| CTRI Number |
CTRI/2025/07/091983 [Registered on: 30/07/2025] Trial Registered Prospectively |
| Last Modified On: |
29/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
"A study that helped mothers of premature babies deal with stress and anxiety by giving them planned guidance and support." |
|
Scientific Title of Study
|
Effectiveness of planned teaching
on knowledge and attitude regarding
coping with stress and anxiety
among mothers of preterm babies. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shardul Timande |
| Designation |
Post graduate student |
| Affiliation |
Datta Meghe Institute Of Higher Education and Research |
| Address |
Department of Child Health Nursing Smt Radhikabai Meghe Memorial College Of Nursing Sawangi Meghe Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
8308258319 |
| Fax |
|
| Email |
shardultimande046@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bibin Kurian |
| Designation |
HOD and Professor of Department of Child Health Nursing |
| Affiliation |
Datta Meghe Institute Of Higher Education and Research |
| Address |
Department of Child Health Nursing in Smt Radhikabai Meghe Memorial College Of Nursing near polic station , meghe apartment 201 room no. Sawangi Meghe Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
7020156450 |
| Fax |
|
| Email |
bibinkurian546@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Bibin Kurian |
| Designation |
HOD cum Professor of Department of Child Health Nursing |
| Affiliation |
Datta Meghe Institute Of Higher Education and Research |
| Address |
Department of Child Health Nursing in Smt Radhikabai Meghe Memorial College Of Nursing near polic station , meghe apartment 201 room no. Sawangi Meghe Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
7020156450 |
| Fax |
|
| Email |
bibinkurian546@gmail.com |
|
|
Source of Monetary or Material Support
|
| Datta Meghe Institute Of Higher Education and Research Sawangi Meghe Wardha Indian 442001 |
|
|
Primary Sponsor
|
| Name |
Datta Meghe Institute Of Higher Education and Research |
| Address |
Sawangi Meghe Wardha Indian 442001 |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Abhay Mude |
Acharya Vinoba Bhave Rural Hospital |
Acharya Vinoba Bhave Rural Hospital near polic station room no 201 at Sawangi Meghe Wardha 442001
Wardha
MAHARASHTRA |
07123521211
info@avbrhsawangimeghe.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F419||Anxiety disorder, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Planned Teaching Program on Coping with Stress and Anxiety |
The intervention was a 30–45 minute planned teaching session for mothers of preterm babies, focused on coping with stress and anxiety. It covered basic information about stress, its effects, and simple coping techniques like deep breathing, positive thinking, and seeking support. Teaching aids such as flipcharts and handouts were used. A post-test was conducted after 7 days to assess improvement in knowledge and attitude. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1. Mothers who are willing to participate in the study
2. Mothers of preterm infants born before 37 weeks of gestation admitted to a Neonatal Intensive Care Unit NICU or special care nursery
3. Mothers who can read or write English Hindi or Marathi |
|
| ExclusionCriteria |
| Details |
1. Mothers with post natal complication
2. Mothers who have previously received significant psychological or counseling interventions for stress or anxiety related to their infants care
3. Mothers who are health professionals |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary outcomes of the study were improved knowledge and a more positive attitude among mothers of preterm babies regarding coping with stress and anxiety after the planned teaching session. |
The primary outcomes of the study were improved knowledge and a more positive attitude among mothers of preterm babies regarding coping with stress and anxiety. These outcomes were assessed at three specific time points: at baseline (before the planned teaching), at 4 weeks post-intervention to measure immediate effectiveness, and at 8 weeks post-intervention to evaluate the retention and long-term impact of the teaching program.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The secondary outcomes included increased use of coping strategies, improved emotional well-being, better mother-infant bonding, greater involvement in newborn care, & a higher willingness to seek support when needed. |
The secondary outcomes of the study included increased use of coping strategies, improved emotional well-being, better mother-infant bonding, greater involvement in newborn care, & a higher willingness to seek support when needed. These outcomes were assessed at three time points: at baseline (before the intervention), at 4 weeks after the planned teaching to evaluate early changes, & at 8 weeks to assess sustained behavioral & emotional improvements over time.
|
|
|
Target Sample Size
|
Total Sample Size="84"
Sample Size from India="84"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
15/10/2025 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
“Effectiveness of Planned Teaching on Knowledge and Attitude Regarding Coping with Stress and Anxiety Among Mothers of Preterm Babies”
Abstract:
Preterm birth can be a highly stressful experience for mothers, often leading to anxiety and emotional distress. This study aimed to assess the effectiveness of a planned teaching program in improving the knowledge and attitude of mothers regarding coping with stress and anxiety. A pre-experimental one-group pre-test and post-test design was used. The study was conducted among mothers of preterm babies admitted to the neonatal intensive care unit (NICU) in a selected hospital. A structured questionnaire and attitude scale were used to assess baseline knowledge and attitude. A 30–45 minute planned teaching session was delivered using simple language, visual aids, and interactive discussion. The content focused on understanding stress and anxiety, their impact on maternal and infant well-being, and practical coping strategies such as relaxation techniques, positive thinking, and emotional support. A post-test was conducted on the 7th day to measure the effectiveness of the intervention.
The results showed a significant improvement in post-test knowledge and attitude scores compared to the pre-test. Mothers reported better emotional awareness and the use of healthy coping mechanisms. The study concludes that planned teaching is an effective method to enhance knowledge and foster a positive attitude among mothers of preterm babies in managing stress and anxiety. Regular education and emotional support in hospital settings can empower mothers and improve maternal-infant outcomes.
Keywords: Preterm baby, stress, anxiety, mothers, planned teaching, coping, knowledge, attitude. |