| CTRI Number |
CTRI/2025/10/096223 [Registered on: 21/10/2025] Trial Registered Prospectively |
| Last Modified On: |
17/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Non-randomized, Multiple Arm Trial |
|
Public Title of Study
|
A study to find out how relaxation, breathing, and support before labour help first time mothers to cope better and have smoother deliveries |
|
Scientific Title of Study
|
Effectiveness of Pre labor intervention on maternal coping strategies and delivery outcomes among primigravida women at selected hospital Mangaluru |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ms Vinushahana PR |
| Designation |
Postgraduate |
| Affiliation |
Yenepoya Nursing College |
| Address |
Postgraduate in Department Of Obstetrics and Gynecological Nursing, Yenepoya Nursing College, Naringana, Mangaluru
Yenepoya Nursing Collge, Naringana, Mangaluru
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9108278227 |
| Fax |
|
| Email |
vinushahanarafeeq786@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mrs Amisha S Amin |
| Designation |
Assisstant Professor |
| Affiliation |
Yenepoya Nursing College |
| Address |
Department Of Obstetrics and Gynecological Nursing, Yenepoya Nursing College, Naringana, Mangaluru
Yenepoya Nursing Collge, Naringana, Mangaluru
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
7349400512 |
| Fax |
|
| Email |
amishaamin@yenepoya.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Ms Vinushahana PR |
| Designation |
Postgraduate |
| Affiliation |
Yenepoya Nursing College |
| Address |
Postgraduate in Department Of Obstetrics and Gynecological Nursing, Yenepoya Nursing College, Naringana, Mangaluru
Yenepoya Nursing Collge, Naringana, Mangaluru
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9108278227 |
| Fax |
|
| Email |
vinushahanarafeeq786@gmail.com |
|
|
Source of Monetary or Material Support
|
| Yenepoya Medical College Hospital, Department of Obstetrics And Gynecology, Deralakatte, Mangaluru,575018, Karnataka |
|
|
Primary Sponsor
|
| Name |
Vinushahana PR |
| Address |
Postgraduate, Department of Obstetrics and Gynecological Nursing , Naringana, Mangalore |
| Type of Sponsor |
Other [] |
|
|
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 Janet Prima Miranda |
Yenepoya Medical College Hospital, Deralakatte, Mangalor |
Department of Obstetrics And Gynecology/ Labour room/ Antenatal ward
Dakshina Kannada
KARNATAKA |
9886933804
janetmiranda@yenepoya.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| YENEPOYA ETHICS COMMITEE-3 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Pregnant women who conceived for the first time and is between the gestational weeks of 38-42 |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Pre-labour intervention 9 breathing, rhythemic movement, possitive affirmation, emotional support) |
It includes antenatal education, breathingexcercises,meditation, positive affirmation,and position change
each participant will receive intervention for approximately 45-60 minutes with reinforcement throughout the first stage
|
| Comparator Agent |
routine care |
participants receive the routine labour care provided by hospital staff without additional intervention |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
Primigravida women at 38-42 weeks of gestation
women who can comprehend and participate in educational sessions |
|
| ExclusionCriteria |
| Details |
High risk pregnancies where vaginal delivery is contraindicated
women with prior exposure to formal childbirth preparation classes |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| maternal coping strategies during labour among primigravida women, measured by copibg with labour algorithm |
assessed during active phase of labour and immediately after delivery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| delivery outcomes such as duration of labour, mode of delivery, condition of newborn, need for obstetrics intervention |
assessed immediatlely after delivery & recorded in the intrapartum & immediate post partum period |
|
|
Target Sample Size
|
Total Sample Size="74"
Sample Size from India="74"
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)
|
29/10/2025 |
| 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="11"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
This study aims to evaluate the effectiveness of a pre-labour intervention including breathing exercises, emotional support, and rhythmic movement on maternal coping and delivery outcomes in first-time mothers. Participants will be divided into two groups: one receiving the intervention and the other receiving routine hospital care. The main outcome is maternal coping during labour, assessed using observation tool, while secondary outcomes include duration of labour, mode of delivery, and maternal well-being. The study will be conducted at Yenepoya Medical College Hospital, Mangaluru, among primigravida women aged 18–35 years.
|