| CTRI Number |
CTRI/2023/01/048657 [Registered on: 02/01/2023] Trial Registered Prospectively |
| Last Modified On: |
18/01/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Depression, anxiety among pregnant women |
|
Scientific Title of Study
|
Depression, anxiety and its associated factors among pregnant women |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
KANKANA CHAKRABORTY |
| Designation |
M. Sc. Nursing Student |
| Affiliation |
LGBRIMH, Tezpur |
| Address |
Academic Building, Department of Psychiatric Nursing, LGBRIMH, Tezpur, Assam, 784001
Sonitpur
ASSAM
784001
India |
| Phone |
9874517927 |
| Fax |
|
| Email |
kankanachakraborty22@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mrs Chitra Bora |
| Designation |
Nursing Tutor |
| Affiliation |
LGBRIMH, Tezpur |
| Address |
Academic Building, Department of Psychiatric Nursing, LGBRIMH, Tezpur, Assam, 784001
Sonitpur
ASSAM
784001
India |
| Phone |
7002539715 |
| Fax |
|
| Email |
chitraborarajbongshi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mrs Chitra Bora |
| Designation |
Nursing Tutor |
| Affiliation |
LGBRIMH, Tezpur |
| Address |
Academic Building, Department of Psychiatric Nursing, LGBRIMH, Tezpur, Assam, 784001
Sonitpur
ASSAM
784001
India |
| Phone |
7002539715 |
| Fax |
|
| Email |
chitraborarajbongshi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Self sponsored
Kanaklata Civil Hospital, Tezpur Assam and Selected Subcenters in Tezpur |
|
|
Primary Sponsor
|
| Name |
Kankana Chakraborty |
| Address |
Academic Building, Department of Psychiatric Nursing, LGBRIMH, Tezpur , Assam, 784001 |
| Type of Sponsor |
Other [Self sponsored] |
|
|
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 |
| Kankana Chakraborty |
OPD of Kanaklata Civil hospital |
Kanaklata Civil hospital, PPC Unit Room no 3 Tezpur and Bihaguri PHC
Sonitpur
ASSAM |
9874517927
kankanachakraborty22@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O00-O9A||Pregnancy, childbirth and the puerperium, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1. Pregnant women of age 18-45 years.
2. Pregnant women who can read, write and understand Assamese and/or English. |
|
| ExclusionCriteria |
| Details |
Pregnant women who can read, write, and understand Assamese and/or English |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
Depression
Anxiety
Associated factors |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Associated factors of Anxiety and Depression |
9 months |
|
|
Target Sample Size
|
Total Sample Size="333"
Sample Size from India="333"
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
|
N/A |
|
Date of First Enrollment (India)
|
02/01/2023 |
| 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)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Pregnancy is a unique period where there is a physical as well as psychological changes. Pregnant women are more vulnerable to depression, anxiety, stress, and psychosis. Globally around 10% of women during pregnancy experience mental disorders, particularly depression. Anxiety and depression are not only affecting women’s health but also have an impact on labor and the postpartum period. Literature suggests that interventions like cesarean section and epidural analgesia during labor are more common among women who had high anxiety and fear during pregnancy. It was also found that an increase in anxiety and depression during pregnancy is associated with postpartum depression, low-birth-weight babies, reduced odds of breastfeeding, and infant negative behavioral reactivity. There is a paucity of studies on depression, anxiety, and its associated factors among pregnant women in North -East region of India. So, this study aims to estimate depression, anxiety, and its associated factors among pregnant women in Tezpur, Assam. A descriptive research design with a quantitative approach will be used for the study. The study will be conducted at Kanaklata civil hospital and selected subcenters in and around Tezpur. Pregnant women in Tezpur will be the population for the study. A total of 333 antenatal women will be included in the study through purposive sampling techniques. A self-structured sociodemographic and clinical proforma, Generalized Anxiety Disorder 7, and Edinburgh Postnatal Depression Scale will be used to collect data on the variables. The tools will be translated to Assamese. Informed consent after proper explanation and assurance of confidentiality and anonymity will be obtained before data collection. After getting the ethical clearance the tools will be applied and the results will be analyzed. Frequency and percentage distribution will be used to describe the demographic data and the Regression analysis will be done to determine the association. |