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CTRI Number  CTRI/2017/11/010666 [Registered on: 27/11/2017] Trial Registered Retrospectively
Last Modified On: 27/05/2015
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Behavioral 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A study to assess the effect of listening visits implemented by village health nurses on postpartum depression 
Scientific Title of Study   A STUDY TO DEVELOP NURSING PROTOCOL ON MANAGEMENT OF POSTPARTUM DEPRESSION FOR VILLAGE HEALTH NURSES AND EVALUATE ITS EFFECTIVENESS AMONG MOTHERS WITH POSTPARTUM DEPRESSION IN COIMBATORE DISTRICT, TAMILNADU. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Yasodha P 
Designation  Assistant Professor 
Affiliation  College of Nursing Sri Ramakrishna Institute of Paramedical Sciences Coimbatore 
Address  14/ 1A1 alamelumangapuram, Ganapathy, Coimbatore- 641006.
395, Sarojini naidu road, Siddhapudhur, Coimbatore-641 044
Coimbatore
TAMIL NADU
641 006
India 
Phone  9944033720  
Fax  04222240521  
Email  yasodhagopi@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Yasodha P 
Designation  Assistant Professor 
Affiliation  College of Nursing Sri Ramakrishna Institute of Paramedical Sciences Coimbatore 
Address  395, Sarojini naidu road, Siddhapudhur, Coimbatore-641 044
395, Sarojini naidu road, Siddhapudhur, Coimbatore-641 044
Coimbatore
TAMIL NADU
641 006
India 
Phone  9944033720  
Fax  04222240521  
Email  yasodhagopi@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Yasodha P 
Designation  Assistant Professor 
Affiliation  College of Nursing Sri Ramakrishna Institute of Paramedical Sciences Coimbatore 
Address  395, Sarojini naidu road, Siddhapudhur, Coimbatore-641 044
395, Sarojini naidu road, Siddhapudhur, Coimbatore-641 044
Coimbatore
TAMIL NADU
641 006
India 
Phone  9944033720  
Fax  04222240521  
Email  yasodhagopi@gmail.com  
 
Source of Monetary or Material Support    
Primary Sponsor  
Name  P Yasodha 
Address  College of Nursing Sri Ramakrishna Intitute of Paramedical Sciences 395, sarojini naidu road New siddhapudur Coimbatore-44 
Type of Sponsor  Other [P Yasodha] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
PYasodha  Primary Health Center , Thudiyalur  Thudiyalur Priyanaikan palayam coimbatore - 641 034
Coimbatore
TAMIL NADU 
9944033720

yasodhagopi@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Sri Ramakrishna Hospital Ethical Coimttee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Village health Nurses and Postpartum Mothers 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  listening visits  protocol will be prepared for village health nurses on management of postpartum depression it includes steps on listening visits for 8 sessions one hour each 
Comparator Agent  Routine treatment for postpartum depression by village health nurses  Routine treatment for postpartum depression by village health nurses at 8thweek 12thweek and 16th week. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  Mother with EPDS score of > 8 without suicidal ideation.
-Mother who delivered within 4 weeks to 6 months of the period of data collection
 
 
ExclusionCriteria 
Details  mother with known history of psychiatric disease
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Mean Edinburgh Postnatal Depression Scale Score.  24 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
village health nurses competency to identify and manage postpartum depression   7th day, 15 day and 30th day 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 1/ Phase 2 
Date of First Enrollment (India)   14/08/2015 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="6"
Days="1" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   not applicable 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

INTRODUCTION AND BACKGROUND

Depression is a significant contributor to the global burden of disease in terms of its prevalence, suffering, dysfunction, morbidity and economic burden. The burden of depression is increased over decades, in 1990 depression ranked as the fourth leading cause of disease burden worldwide after lower respiratory infections, diarrheal diseases, and conditions arising during the perinatal period. In the year 2000 depressive disorders were the third leading cause of disease behind lower respiratory infections and diarrheal disease. Depressive disorders now rank second in terms of global disability burden, according to the 2010 Global burden of Disease report.1 In 2012, depression is estimated to affect 350 million people in all communities at all age groups across the world. It also reported that, if current trends for demographic and epidemiological transition continue, by the year 2020 depression would be the foremost cause of disability – adjusted life years (DALYs), secondary to ischemic heart disease.2

Though depression is the primary cause of disability for both genders, the burden is 50% higher for females than males. In fact, depression is the leading cause of disease burden for women in both high- income and low- and middle-income countries. The report on Global burden of Disease estimates the point prevalence of unipolar depressive episodes to be 1.9% for men and 3.2% for women, and the one-year prevalence has been estimated to be 5.8% for men and 9.5% for women.2 In women’s life time the risk is particularly high around child birth period, especially the postnatal period is well established as an increased time of risk for the development of serious mood disorders. Depression after child birth is known as postpartum depression.

Postpartum depression is a mood disorder characterized by a prolonged period of emotional disturbance, occurring at a time of major life change and increased responsibilities in the care of a newborn that begins after childbirth and usually lasts beyond six weeks.71 By definition postpartum depression is a non psychotic depressive episode of mild to moderate severity, beginning in or extending into the first postnatal year. Beck described it as a thief that steals motherhood.4

Studies reported that the global prevalence of postpartum depression is from 5% to 25%.5Halbreich and Karkun, reviewed 143 studies to identify the prevalence of postpartum depression around worldwide. The results found that there is a wide range of reported prevalence of postpartum depression ranging from 0% to 60%. The authors concluded that the widely cited mean prevalence of postpartum depression 10% to 15% is not representative of the actual global prevalence and magnitude of the problem, due to wide range of reports.72

Bener et al reported that among Arab women prevalence of postpartum depression was 18.6%, compared to the prevalence of anxiety 13.1% and stress 8.7%.73 A study by Matthey et al also showed similar psychological morbidity among postpartum mothers, with 17% of prevalence for postpartum depression and 13% for anxiety.74 In the same range, a population – based survey of Australian women reported that the prevalence rate 17.4% for postpartum depression and 12.7% for anxiety.75

Hegde et al, found that in India the prevalence of depression was 11.3% in the immediate postpartum week, 15.8% at six weeks and 15.5% at fourteen weeks after delivery.6 Patel reported that prevalence of post-partum depression was  23% among Goa women in India.7 Nimisha et al found that, 12.5 % of Gujarati women affected with postpartum depression .8 Chandran M, reported the incidence of postpartum depression was 11%  among women from rural area of Tamil Nadu, India.9  These results consistently suggest that more than 10% of mothers suffer from depression, in the postpartum period.

Commonly identified predictors of maternal common mental disorders in South Asia include low socio-economic status, lack of social support, adverse life events, disappointment with the sex of the baby and a bad relationship with a mother-in-law or partner.9A cross-sectional community-based study identified  that high maternal age, low asset ownership, health problems in the ante partum, delivery or postpartum periods, caesarean section, an unwanted pregnancy for the mother, small perceived infant size and a stillbirth or neonatal death are the predictors of maternal psychological distress in a rural, largely tribal community sample in eastern India.12 Another qualitative study in the community from rural south India shows that the following factors were associated with postpartum depression: age less than 20 or over 30 years, schooling less than five years, thoughts of aborting current pregnancy, unhappy marriage, physical abuse during current pregnancy and after childbirth, husband’s use of alcohol, girl child delivered in the absence of living boys and a preference for a boy, low birth weight and a family history of depression.13

A study of mothers in Goa shows that economic deprivation, poor marital relationship, the gender of infant as important risk factors for occurrence of postpartum depression.7 Nimisha,  identified that the gender of the child especially birth of girl when boy desired was the significant factor for PPD. Other factors include, multi gravida, women having past history of miscarriage, women feeling tense during pregnancy, women who could not share a confidence with partner and absence of someone other than mother and partner in whom the woman could confide were found to be the strongest predictors for developing postpartum depression among Guajarati women.8

In a cohort study from rural area of Tamil Nadu found that, Low income, birth of a daughter when a son was desired, relationship difficulties with mother in law and parents, adverse life events during pregnancy and lack of physical help were risk factors for the onset of post partum depression.9According to Sichel and Driscoll’s ‘EARTHQUAKE MODEL’, these risk factors can repeatedly weaken a mother’s fault line placing her in a dangerous position for an emotional earthquake, such as post partum depression.14

There is now considerable evidence to show that postpartum depression has a substantial impact on the mother and her partner, 15 the family, 16mother baby interactions, 17 and the longer term emotional and cognitive development of the baby, 18 especially when depression occurs in the first year of life.19 Though clinically and cost effective treatments are available, 20, 21 less than half of cases of postpartum  depression are detected in routine clinical practice.21, 22 Considering not only the high prevalence, and also the consequences of postpartum depression make it important public health issue need to be identified and treat as early as possible. So many studies addressed that postpartum depression screening is feasible in the outpatient setting and can improve the rates of detection and treatment.76, 77In a recent Md current- India survey, 70% of doctors delivering 5 are more babies a week did not always screen for postpartum depression.

Key components of postpartum depression screening includes, which screening test or instrument to use, when to screen, who should screen and how to use the results of the screening test. Edinburgh postnatal Depression Scale (EPDS) is a validated instrument for screening of postpartum depression. EPDS is a short screening tool, easy to complete, free to providers, has been used in multiple ethnic and socioeconomic groups and settings and is available in multiple languages. Tamil version of Edinburgh postpartum depression scale available with a sentivity of 94.1% and a  specificity of 90.2% .EPDS increased the rate of diagnosis of postpartum depression  from 3.7% before screening to 10.7% post screening, with 19.8% of women having an abnormal screening test.

The Postpartum depression screening may be administered at any stage after birth. Very high scores within the first week may indicate severe “baby blues” and in this, in turn, may signal that postnatal depression likely to eventuate. Routine administration at 6-8 week, with repetition between 3-6 months is recommended, however, screening through to 12 months is beneficial. The minimum time period which the EPDS should be re administered    is after two weeks of initial assessment. The provider and the nature of his/her relationship with the mother may affect the willingness of the women to admit the symptoms of depression. Postpartum screening tool can be administered by any health professional who understands its use.

Several treatments options are available for postpartum depression, including antidepressants, psychotherapy and counselling. Many mothers with postpartum depression are hesitant to take antidepressants due to concerns about infant exposure to medication through breast milk or concerns about potential side effects48, and therefore often prefer psychological treatments.49 A Cochrane meta-analysis of ten randomized controlled trials of psychosocial and psychological treatments for postpartum depression concluded that both psychosocial and psychological interventions are effective in decreasing depression and are viable treatment options for postpartum depression.50

A qualitative systematic review was done by Dennis CL, Chung-Lee L, to identify postpartum depression help-seeking barriers and maternal treatment preferences. A common help-seeking barrier was women’s inability to disclose their feelings, which was often reinforced by family members and health professionals’ reluctance to respond to the mothers’ emotional and practical needs. The lack of knowledge about postpartum depression or the acceptance of myths was a significant help-seeking barrier and rendered mothers unable to recognize the symptoms of depression. Women preferred to have "talking therapies" with someone who was nonjudgmental rather than receive pharmacological interventions.24

Previous research on depression in primary care practices has identified 3 general types of barriers to effective depression diagnosis and treatment: patient-centered, physician-centered, and systems barriers.52  Patient-centered variables include cost and lack of insurance coverage,time constraints,53,57 social stigma,53,55 non adherence to depression treatment, lack of follow-through with mental health referrals, and lack of access to care for various reasons.55 Physician centered variables include lack of time,56,55 managed care policies, competing demands,54 insufficient training/knowledge, insurance or payment problems, and fear of legal repercussions. Systems based variables also play a role and include infrequent follow-up visits for mothers, lack of objective, proactive monitoring of recovery, and separation of primary care and mental health services.54 In addition, mothers of infants may experience barriers that are unique to the postpartum or early child-rearing period, such as need for childcare during mental health visits, 57 concern about medication effects on nursing infants,58 and fear of judgment and referral to child protection.59

Despite these numerous barriers, the opportunities afforded by postpartum depression screening and treatment are potentially vast and include not only improving the signs and symptoms of postpartum depression, but also enhancing the new mother’s ability to parent, and her ability to continue to actively participate in a marriage or relationship. Recognizing and treating postpartum depression provides opportunities to decrease divorce rates, improve rates of normal child development and lower suicide and infanticide rates.60-65

NEED FOR THE STUDY

Postpartum depression is a hidden but important public health problem, depression during postpartum period compromises a woman’s parenting ability this, in turn, is associated with delays in cognitive, social and emotional development of exposed children.

Given the potentially serious consequences of postpartum depression, it is unfortunate that the rates of diagnosis and treatment of this serious problem are low38-40 primarily because of lack of recognition.  According to WHO depression can be reliably diagnosed and treated in primary care. Studies that have addressed postpartum depression screening demonstrate that screening is feasible in the outpatient setting and can improve the rates of detection and treatment.42

Vaishnavi et al studied on inequity in provision of maternal health care services in Tamil Nadu and Kerala, by using the National sample survey organization database on morbidity and health care (2004). The results found that, In Tamil Nadu public sector  antenatal care utilization was 68 percent in rural regions and 53 percent in urban regions, few (5%,n=35,489) and urban(1%; n=5937) women did not seek antenatal care . Regarding patterns of utilization of Institutional delivery, Urban Tamil Nadu had 97 percent institutional delivery, while in rural regions institutional delivery was 88 percent. In rural Tamil Nadu home deliveries were about 12 percent, of which 85 percent was concentrated among lower three quintiles. Patterns of utilization in postnatal care reveals that, public health system was the major provider of postnatal care in rural Tamil Nadu(54%), While 40% of postnatal care was provided by public providers in urban regions, about 22 percent(n=587834) rural women and 26 percent(n=301596) urban women did not seek postnatal care, of which more than 77 per cent belonged to lower quintiles. Authors concluded that in Tamil Nadu, improvement in all the three maternal health care services particularly in rural region is required.

Though most of the women receives postnatal care, in routine postnatal care were importance given to general examination of the mother and baby were mental health of the mother were largely neglected. Many literatures found that, postpartum mood disorders can be reliably diagnosed by community health workers.

Segre LS et al assessed nurses’ views of a nursing model in which nurses’ screen and also treat new mothers who exhibit symptoms of depression. Results found that, the majority of nurses “strongly agreed” or “agreed” with the statement “having nurses screen for depression using a brief screening tool is a good idea”. Most (67.1%) chose the Ob-Gyn Clinic as the appropriate site for such screening.45  A descriptive qualitative study explores the use of a procedure for postpartum depression screening by public health nurses in a Norwegian municipality, and is based on in-depth interviews. The 11 nurses regarded the screening procedure as valuable and felt that the training they had received in its use made them more confident about supporting parents by discussing mental health problems. They found the Edinburgh Postnatal Depression Scale easy to score and easy for the mothers to complete, and they identified PPD more frequently than before.46Women also had favourable views of being screened by nurses for depression. According to the study conducted by Segre, the majority (95.4%) indicated a willingness to complete a depression screening tool given by a nurse. When asked to indicate appropriate settings for a screening program (respondents could choose more than one), the most frequently chosen settings were the home, the Family Practice clinic (51.9 %,), and the Ob-Gyn clinic.47

In the study on Nurses views on offer both Screening and Counselling for postpartum depression, the vast majority of nurses (93.7%) “Agreed” or “strongly agreed” with the statement “nurse-delivered counselling with mildly depressed women is a good idea.” Almost one-half of the nurses already regularly provided some form of counselling and approximately three quarters were willing to participate in a counselling skills training program. Respondents were evenly divided regarding whether nurse-delivered counselling should be taught to all nurses working with pregnant and postpartum women or whether it should be a specialty area for those nurses who would provide treatment. Less than 1.0% indicated that nurse-delivered counselling should not be implemented. The most frequently chosen setting for a nurse-delivered counselling program was home visits followed by the Ob-Gyn Clinic, the Family Practice Clinic, and the Paediatric Clinic . The extent to which the nurses in this sample already provided counselling differed significantly according to employment setting, with three distinct groups emerging: 1) administrators rated themselves as “never” providing counselling; 2) nurses in clinics frequented by postpartum women rated themselves as “occasionally” providing counselling, and 3) psychiatric nurses rated themselves as “usually” providing counselling.45

Women also reported positive views of being counselled for depression by a nurse: most felt “depression counselling by a nurse is better than not receiving any treatment.” Fewer than one in five considered depression counselling by nurses to be risky. Only eight out of 132 indicated they would not be willing to see a nurse for treatment. In fact, most of the mother “strongly agreed” or “agreed” with the item, “I would be more likely to obtain help from a nurse than another type of mental health professional.” When asked from which type of professional they would prefer to obtain mental health care, this sample of low-income women most frequently chose nurses followed by social workers ,and then obstetricians or other physicians . When asked to indicate appropriate settings for a nurse delivered counselling program (respondents could choose more than one) these women most frequently chose the home, followed by the Family Practice clinic, the Ob-Gyn clinic, and the Paediatric clinic.47

Appleby et al recommended that training health visitors in psycho social therapies leads to improved counselling skills and corresponding changes in management of postpartum depression, without increasing the costs of health visitor practice.  Authors also suggested that nurses in perinatal settings should screen their patients for depression, both as a part of a woman’s care and during paediatric care for their children. Implementation of a nurse-delivered perinatal screening will require educational programs for staff as well as the establishment of a screening protocol and referral sources. Screening and referral often highlight the lack of treatment resources and/or reluctance on the part of women to see a mental health professional.51 Glavin K et al examined the effect of supportive counselling by public health nurses on postpartum depression. Results found that Supportive counselling based on a non-directive counselling method provided by public health nurses is an effective treatment method for postpartum depression.67

Morrell C et al did a clustered randomised trial to assess the effectiveness of training health visitors on screening and deliver psychologically informed interventions for postnatal depression. Health visitors are randomly divided in to one of three groups, first group trained to deliver cognitive behavioural approaches for postpartum depression, another group for person centred approach and control group health visitors delivered routine care and the outcomes are assessed with Edinburgh Postnatal Depression Scale. Results found that health visitor training reduced the proportion of women who were still at risk after 6 months compared with usual care 33.9% with training 45.6% with usual care; this effect remained for 1 year. Within the training group, there was no significant difference in the proportion of women remaining at risk between the cognitive behavioural approach and person centred approach. Economic analyses found that the training was highly likely to be cost effective compared with the control.66

Literature shows, well documented prevalence and consequences of postpartum depression if left unidentified and untreated. In primary care psychological interventions are as clinically effective in the management of depression as routine care from a village health nurse. In spite of this evidences, researcher identified there is a gap in the identification and management of postpartum depression in the primary care setup especially in India. Hence, the researcher planned to develop and nursing protocol for village health nurses on postpartum depression management.

 

 

 

STATEMENT OF THE PROBLEM

A STUDY TO DEVELOP NURSING PROTOCOL ON MANAGEMENT OF  POSTPARTUM DEPRESSION  FOR VILLAGE HEALTH NURSES AND EVALUATE ITS EFFECTIVENESS AMONG MOTHERS WITH POSTPARTUM DEPRESSION  IN COIMBATORE DISTRICT, TAMILNADU.

RESEARCH QUESTIONS

1.      Does the nursing protocol useful for village health nurses in acquiring adequate knowledge and competency in screening and managing postpartum depression?

2.      Does the training of village health workers in using of nursing protocol result in improvement of knowledge and competency of village health nurses on screening and management of postpartum depression?

3.      Does nursing protocol on management of postpartum depression will be effective in decreasing the level of depression among mothers with postpartum depression?

 

4.      Were the mothers with postpartum depression satisfied with the care given by village health nurses?

 

 

 

 

 

 

 

OBJECTIVES

·         To develop a nursing protocol on management of postpartum depression for village health nurses.

·         To develop and conduct a training programme on screening and management of postpartum depression for village health nurses.

·         To evaluate the knowledge and competency  of village health nurses in screening and management of postpartum depression before and after the training programme in the experimental group and control group

·         To determine the relationship between knowledge and competency of village health nurses after the training programme on screening and management of postpartum depression.

·         To determine the association between knowledge, competency of village health nurses with selected demographic variables.

·          To evaluate the level of depression among postpartum mothers before and after implementation of nursing protocol on management of postpartum depression by village health nurses in experimental group.

·         To determine the level of satisfaction of the postpartum mothers regarding screening and management of postpartum depression by village health nurses using nursing protocol.

·          To determine the utility of nursing protocol on management of postpartum depression among village health nurses.

 

 

 

RESEARCH HYPOTHESES

H1:  The mean post test knowledge score on nursing protocol in 7th, 15th and 30th day will be significantly higher than the mean pre test knowledge score on nursing protocol of village health nurses in experimental group as measured by structured knowledge questionnaire at 0.05 level of significance.

H2:  The mean post test knowledge score of nursing protocol on day 7th, 15th and 30th of village health nurses in experimental group will be significantly higher than the mean post test knowledge score of control group as measured by structured knowledge questionnaire at 0.05 level of significance.

H3: The mean post test competency score related to nursing protocol on 7th, 15th and 30th day will be significantly higher than the mean pre test competency score of village health nurses in the experimental group as measured by counselling competencies scale at 0.05 level of significance.

H4:  The mean post test competency score of nursing protocol on day 7th,15th and 30th  of village health nurses in experimental group will be significantly higher than the mean post test competency score of control group as measured by counselling competencies scale at 0.05 level of significance.

H5: There will be significant relationship between the knowledge and competency level on nursing protocol of the village health nurses in the experimental group after the training programme at 0.05 level of significance.

H6: There will be a significant association between the knowledge, competency on nursing protocol of the village health nurses in the experimental group with selected variables at 0.05 level of significance.

H7: The mean post test EPDS score  on 8th,12th and 24th week  will be significantly lower than the mean pre test EPDS of mothers with postpartum depression in experimental group as measured with EPDS at 0.05 level of significance.

H8: The mean post test EPDS score on 8th, 12th and 24th week will be significantly lower than the mean post test EPDS score of control group as measured by EPDS at 0.05 level of significance.

OPERATIONAL DEFINITIONS

Nursing protocol on management of postpartum depression:

It includes specific guidelines for village health nurses regarding screening and management of postpartum depression. It includes the following aspects:

Part I: Includes definition, risk factors, clinical manifestations and complications of postpartum depression.

Part II: Screening of postpartum depression, application of EPDS its scoring and interpretation.

Part III: Steps of Listening visits

Part IV: Referring the mother to specialist consultation.

Village health nurse: Refers to Auxiliary Nurse Midwives/MPHW who is working at sub centre level of Coimbatore district.

Postpartum depression: Non psychotic depressive episode with onset of 4 weeks after childbirth, which will be assessed with EPDS score of > 8 on EPDS, indicates probable risk of developing postpartum depression.

Postpartum mother: Refers to a mother who are in the period of 4 weeks to 6 months of postpartum period, above 18 years of age, not an anaemic and without suicidal ideas.

Training programme: It refers to a programme which aims at training of village health nurses on screening and management of postpartum depression.

The training programme includes,

·         Postpartum depression screening workshop, which includes,

§  Definition of postpartum depression

§  Prevalence and risk factors

§  Clinical manifestations

§  Negative effects of postpartum depression.

§  Screening methods

§  EPDS – application and scoring

·         Listening visits workshop

§  Description of listening visit

§  Teaches the component of listening visit

·         Introducing listening visits to the mothers

·         Active reflective listening

·          Collaborative problem solving

Through lectures, exercises and video-demonstrations.

·         Knowledge:

It refers to the ability of the village health nurses to respond to the questions regarding screening and management of postpartum depression as evident from knowledge score as measured by structured knowledge questionnaire.

 

·         Competency: 

Refers to the ability of the village health nurses to perform non-directive counselling in the form of listening visit as evident from competency score measured by counselling competencies scale.

CONCEPTUAL FRAMEWORK

Context, Input, Process, and Product Evaluation Model (CIPP)

The CIPP model of evaluation was developed by Daniel Stufflebeam and colleagues in the 1960s. The CIPP model represents a holistic approach to conducting evaluations of education, health and other public programs. The acronym CIPP represents the four main components of this type of evaluation: context, input, process and product. According to Stufflebeam, the objective of context evaluation is to assess the overall environmental readiness of the project, examine whether existing goals and priorities are attuned to needs, and assess whether pro­posed objectives are sufficiently responsive to assessed needs. The purpose of an input evaluation is to help prescribe a program by which to make needed changes. During input evaluation, experts, evaluators, and stakeholders identify or create potentially relevant approaches. Then they assess the potential approaches and help formulate a responsive plan. Process evaluation affords opportuni­ties to assess periodically the extent to which the project is being carried out appropriately and effectively. Product evaluation identi­fies and assesses project outcomes, both intended and unintended.68

Specifically, CIPP evaluation model as a comprehensive framework to guide the planning, implementation, and assessment of service-learning programs this can help to identify service providers’ learning needs and the community’s needs. The input evaluation component can then help prescribe a responsive project that can best address the identified needs. Next, the process evaluation component monitors the project process and potential procedural barriers, and identifies needs for project adjustments. Finally, the product evaluation component measures, interprets, and judges project outcomes and interprets their merit, worth, sig­nificance, and probity.6

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 





                                

 



 

 


                                                                          


 

 

 

 

 

 


RESEARCH METHODOLOGY

APPROACH         

 For the present study the researcher plans to adopt quantitative approach to achieve the objectives of the study.

DESIGN 

The researcher plans to adopt true experimental pre test-post test with control group design to fulfil the objectives of the study. 

The study will be conducted in two phases

Phase I : Development of Nursing protocol and training of Village Health Nurses in  implementation of  nursing protocol

Phase II: Implementation of Nursing protocol on management of postpartum depression by Village health nurses and evaluating its effectiveness in terms of reduction in level of depression among mothers with postpartum depression.

PHASE- I      (TRAINING OF VILLAGE HEALTH NURSES)

Group

Pre test

( Day 1)

Intervention

( Day 1)

Post test

( Day 7)

Post test

(Day 15)

Post test

( Day 30)

RE

OK1  OC1

X

OK2  OC2

OK3  OC3

OK4     OC4

Rc

OK1  OC1

--

OK2  OC2

OK3  OC3

OK4     OC4

 

RE - Randomly selected Experimental group of VHNs

RC - Randomly selected Control group of VHNs

OK1 – Assessment on Knowledge of VHNs before administration of Training programme.

OC1- Assessment on Competency of VHNs on non directive counselling before administration of Training programme.

X- Administration on training programme for VHNs on screening and management of postpartum depression

OK2- Assessment on Knowledge of VHNs on 7th day of after administration of Training programme.

OC2- Assessment on Competency of VHNs on 7th day of after administration of Training programme.

OK3- Assessment on Knowledge of VHNs on 15th day of after administration of Training programme.

OC3- Assessment on Competency of VHNs on 15th day of after administration of Training programme.

OK4- Assessment on Knowledge of VHNs on 30th day of after administration of Training programme.

OC4- Assessment on Competency of VHNs on 30th day of after administration of Training programme.

 

PHASE- II (EVALUATION OF EFFECTIVENESS OF NURSING PROTOCOL OF MANAGEMENT OF POSTPARTUM DEPRESSION)

Group

Pre test

( Day 1)

Intervention

(8 Weeks )

Post test

( End of 8th week)

Post test

(End of 12th week)

Post test

( End of 24th week)

RE

OD1

X

OD2

OD3

OD4

Rc

      OD1

--

OD2

OD3

OD4

 

RE – Randomly selected experimental group of mothers with postpartum depression

 

RC – Randomly selected control group of mothers with postpartum depression

 

OD1- Assessment on level of depression with EPDS before administration of listening visits.

OD2- Assessment on level of depression with EPDS at the end of 8th week after administration of listening visits.

 

OD3- Assessment on level of depression with EPDS at the end of 12th week after administration of listening visits.

 

OD4- Assessment on level of depression with EPDS at the end of 24th week after administration of listening visits.

 

VARIABLES IN THE STUDY

 

PHASE I:

·         Independent variable:  Training programme on screening and management of PPD

·         Dependent  variable: Knowledge and competency of VHNs

 

 PHASE II:

·         Independent variable:  Nursing protocol on management of Postpartum depression

·         Dependent variable:  Level of depression among mothers with postpartum depression.

 

SETTING OF STUDY

This proposed research will be conducted in Coimbatore district. In Coimbatore primary health care was delivered through primary health centres and sub centres. There will be one village health nurse for each sub centre which covers 8,000 to 20,000 populations. Coimbatore district includes 328 sub centres. The eligibility of setting was determined based on availability of village health nurses in sub centre, 67 sub centres were excluded because of non availability of village health nurse. Remaining of 251 sub centres was included as setting in the study.

POPULATION

PHASE I: All the VHN’s who are working at the sub centre level in Coimbatore district

PHASE II: All  Mothers with postpartum depression who are attending sub center

SAMPLING

PHASE I:  Multi stage random sampling

Initial stage blocks in Coimbatore district will be randomly selected

PHC’s will be randomly selected from each block

Sub centres under each PHC will be further selected through randomization

The sub centres will be randomly allocated to experimental and control group

The VHN’s belong to the experimental sub centres will be the experimental group and who belongs to control group sub centres will be the control group.

PHSAE II: Simple random sampling by using lottery method.

Mothers with postpartum depression belongs to selected sub centre population will be randomly selected by using simple random sampling.

 

Sample size:

PHASE I:    60 Village health nurses

Experimental group – 30, Control group – 30

PHASE II:  120   mothers with postpartum depression

Experimental group – 60, Control group - 60

CRITERIA FOR SELECTION OF SAMPLES

Inclusion criteria:-

-          Mother with EPDS score of > 8 without suicidal ideation.

-          Mother who delivered within 4 weeks to 6 months of the period of data collection.

-          Aged 18 years are more.

Exclusion criteria:-

-          Pregnant at baseline.

-          With pervious history of psychosis.

-          Mothers who are taking anti psychotic medication.

-          Mothers who are anaemic having haemoglobin less than 8 gm/ dl.

TOOLS & TECHNIQUES

PHASE I:

ASSESSMENT

TOOL

TECHNIQUE

Assessment on knowledge of VHNs regarding screening and management of postpartum depression.

Structured  knowledge  questionnaire

Paper pencil technique.

Assessment  on competency of  VHNs  on  listening visits     

Counselling competencies scale

Observation

 

 

PHASE II

ASSESSMENT

TOOL

TECHNIQUE

 Assessment of suicidal ideation

 

Suicide  behaviour questionnaire – revised

Paper  pencil technique

Haemoglobin level of the mother

 WHO Haemoglobin  colour scale

Observation

Assessment on  level of depression among mothers with postpartum depression

Edinburgh postnatal depression scale

 

Paper pencil technique.

Assessment on   level of satisfaction of the postpartum mothers regarding screening and management of postpartum depression by village health nurses.

 

 Satisfaction scale

 

Paper pencil technique

Assessment of the utility of nursing protocol on management of postpartum depression among village health nurses.

Opinionaire question on ?

Paper pencil technique

 

DESCRIPTION OF THE TOOL

STRUCTURED KNOWLEDGE QUESTIONNAIRE

The structured knowledge questionnaire comprises of two sections

 Section A: comprises of information pertaining to the VHN’s background characteristics

Section B: comprises of items pertaining to knowledge covering the following areas:

Ø  Definition of postpartum depression

Ø  Risk factors for postpartum depression

Ø  Clinical manifestations

Ø  Screening of postpartum depression

Ø   Management of postpartum depression

COUNSELLING COMPETENCIES SCALE

The Counselling Competencies Scale (CCS) includes three parts,

Ø  Primary counselling skills

Ø  Professional dispositions

Ø  Primary professional behaviours

Jacqueline et al examined the psychometric properties of the Counselling Competencies Scale. The results found that interrater reliability for the CCS score was .570, and criterion- related validity was .407. Thus, the results provided support for using the CCS to assess the counselling professional competencies.

SUICIDE BEHAVIOUR QUESTIONNAIRE – REVISED         

The Suicide Behaviors Questionnaire- Revised ( SBQ- R) has 4 items,

·         Item 1 taps into lifetime suicide ideation and /or suicide attempt

·         Item 2 assesses  the frequency of suicidal ideation over the past twelve months

·         Item 3 assesses the threat of suicide attempt

·         Item 4 evaluates self reported likelihood of suicidal behaviour in the future.

This scale is available with sensitivity of 93% and specificity of 95%.

 

 

WHO HAEMOGLOBIN COLOUR SCALE

WHO haemoglobin colour scale is a scale which indicates haemoglobin level by dropping of blood on a test strip provided with six colours to find the closest match. The six shades of red reflect haemoglobin levels at 4, 6, 8, 10, 12, and 14 g/dl. The haemoglobin level will indicate whether the patient is anaemic and the severity of anaemia

EDINBURGH POSTNATAL DEPRESSION SCALE

EPDS is a self report scale includes, 10 – item instrument to assess the depressive symptoms in postpartum period. Tamil version of EPDS available with sensitivity 86% and   specificity of 78%.

INTERVENTION

PHASE I:

Training programme on screening and management of postpartum depression among VHNs.

PHASE II:

            Implementation of nursing protocol on management of postpartum depression by VHN for mothers with postpartum depression.

 

ETHICAL CONSIDERATIONS AND CLEARANCE

-          The ethical approval will be obtained from the institutional ethical committee.

-          The formal administrative permission will be obtained from District directorate Health, Coimbatore.

-          Informed consent will be    taken from the VHN’s willing to participate in the study

-          Written consent will be obtained from the mothers before proceeding.

-          Anonymity and confidentiality of the data will be maintained.

 

 

PLAN FOR PILOT STUDY

-          The pilot study will be conducted in the Thudiyalur block which includes 10 sub centres to find out the feasibility of the tool and the study.

-          Pilot study will be conducted on 10 VHNs in Phase I ( 5 in experimental group and 5 in control group)

-          In Phase II 20 mothers with postpartum depression will be selected.( 10 for experimental group and 10 for control group)

PROCEDURE OF DATA COLLECTION

·         Formal administrative permission will be obtained from the medical officer of the concerned PHC under which the sub centre falls.

·         The VHNs will be informed about the training programme during the monthly review meeting at the PHC by the medical officer and the investigator.

·         The sample will be selected as per the sampling process for the experimental and control group.

DURING PHASE I OF THE STUDY:

·         On day one : Assessment on  knowledge and  competency of the VHN’s will  be done using structured knowledge questionnaire followed by the counselling competencies scale will be carried out in experimental and control group.(Pre test)   

·         On the same day :  Intervention ( Training programme on screening and management of postpartum depression ) will be administered to experimental group whereas no treatment will be given to the control group ( treatment)

·         On day 7th 15th and 30th day: Assessment of the  knowledge and competency of the VHN’s will be done when they are called for the follow up meeting during which the structured knowledge questionnaire  and counselling competency scale will be administered for  experimental and control group  to evaluate the effectiveness of the training programme ( post test).

              DURING PHASE II OF THE STUDY:

·         Formal administrative permission will be obtained from the medical officer of the concerned PHC under which the sub centre falls.

·         The subjects ( mother with postpartum depression) will be selected as per the sampling process for the experimental and control group

·         The subjects will be informed about the research and informed consent will be taken.

·         On day one:  Assessment on  level of depression among mothers with postpartum depression will be done by using EPDS in experimental and control group ( Pre test)

·         Day one to eight weeks (Weekly once / one hour):  Experimental group mothers will be receives listening visits by VHNs based on nursing protocol on management of postpartum depression whereby control group receives routine care by VHNs.(Treatment)

·         End of 8th, 12th and 24th week:  Assessment on the level of depression among mothers with postpartum depression will be assessed for both experimental and control group to evaluate the effectiveness of the nursing protocol on management on postpartum depression implemented by VHNs. ( post test)

·         The satisfaction of the mothers with regard to the care provided to them by VHNs will be assessed at end of 24th week.

·         The utilization of the nursing protocol will be assessed among VHNs at the end of 24th week

 

PLAN FOR DATA ANALYSIS & STATISTICAL APPLICATION

·         The data will be analysed using descriptive and inferential statistics (Phase I &Phase II)

·         Frequency and percentage will be used to describe the sample characterises

·         Mean, median, standard deviation will be calculated

·         “t” test will be done to determine the difference between per test and post test mean in experimental and control group

·         Co efficient of correlation between pre test and post test knowledge and competency score mean will be calculated for experimental group.

·         Chi square test will be done to determine the association of knowledge and competency of VHNs with selected variables.

CONCLUSION                                                                                       

Postpartum depression is a disorder of major public health importance, in terms of its prevalence and consequences. In spite of well documented risk factors and health consequences it often remains undetected and untreated. There are numerous barriers for identification and management of postpartum depression includes social stigma, non availability of services, and lack of recognition from health care team, concern about medication effects and fear of being diagnosed with mental disorder. Regardless of these barriers, the opportunities for early identification and management of postpartum depression are vast, including screening and care by primary health care workers and following proper referral system. Hence the researcher plan to develop and evaluate the effectiveness of nursing protocol on postpartum depression management for the use of village health nurses to screen and manage postpartum depression and follow appropriate referral system.

 

 

ACTION PLAN

Particulars

year

Time line

Problem selection & approval

2012

July 2012

Review of literature

 

July 2012 to continue till end of the study

Development of synopsis

2013

July to January 2013

Construction of tools

 

February – September 2013

Proposal defence presentation

2014

January 2014

Ethical Clearance

 

February 2014

Translation and testing of instruments

 

February 2014 – April 2014

Pilot study and analysis

 

May 2014 – December 2014

Data Collection for final study

2015

January 2015- August 2015

Analysis and interpretation

 

September 2015- December 2015

Report writing

2016

January 2016 – July 2016

Submission to the University

 

July 2016

 

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