| CTRI Number |
CTRI/2026/02/104310 [Registered on: 19/02/2026] Trial Registered Prospectively |
| Last Modified On: |
18/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Health Teaching Programme] |
| Study Design |
Other |
|
Public Title of Study
|
Randomized control Trial of Midwife led counselling programme on tocophobia among Pregnant women |
|
Scientific Title of Study
|
The effect of Midwife Led Counselling Programme on Tocophobia among pregnant women of selected hospitals of central Gujarat: A Randomized Control Trial. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ishita Shah |
| Designation |
PhD Scholar |
| Affiliation |
Manikaka Topawala Institute of Nursing/Charotar University of Science and Technology |
| Address |
Room no 301 Manikaka Topawala Institute of Nursing Charusat
University Changa Anand
Anand
GUJARAT
388421
India
Anand
GUJARAT
388421
India |
| Phone |
7567246289 |
| Fax |
|
| Email |
ishitashah.nur@charusat.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
DrAnjali Tiwari |
| Designation |
Associate Professor |
| Affiliation |
Manikaka Topawala Institute of Nursing/Charotar University of Science and Technology |
| Address |
Room no:109
Manikaka Topawala Institute of Nursing Charusat
University Changa Anand
Anand
GUJARAT
388421
India
Anand
GUJARAT
388421
India |
| Phone |
8141060265 |
| Fax |
|
| Email |
anjalitiwari.nur@charusat.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Ishita Shah |
| Designation |
PhD Scholar |
| Affiliation |
Manikaka Topawala Institute of Nursing/Charotar University of Science and Technology |
| Address |
Room no 301 Manikaka Topawala Institute of Nursing Charusat
University Changa Anand
Anand
GUJARAT
388421
India
Anand
GUJARAT
388421
India |
| Phone |
7567246289 |
| Fax |
|
| Email |
ishitashah.nur@charusat.ac.in |
|
|
Source of Monetary or Material Support
|
| Akshar Gynec Hospital near Shaneshwar Temple, Desai Vago, Kheda, Gujarat, 387001 India |
| CHARUSAT Health Care & Research Foundation is located at CHARUSAT Campus, off Nadiad–Petlad Highway, Changa, Anand, Gujarat, 388421 India |
| Chaturbhai Gangadas General Hospital is situated at Charotar Medical Relief Society, Opposite Yash Papad, near Bus Stand, Uttarsanda, Kheda, Gujarat, 387370 India |
| Himalaya Hospital behind Bachapan School near Indira Gandhi Statue, Anand, Gujarat, 388001 India |
| Kashiben Gordhandas Patel Children Hospital is located at Kashiben Gordhandas Patel Children Hospital, Jalaram Marg, Karelibaug, Vadodara–390018, Gujarat, India |
| N. D. Desai Faculty of Medical Science & Research Dharmsinh Desai University, College Road, Kheda, Gujarat, 387003 India |
| Neeta Maternity & Gynec Hospital C3 B5 Dayal Nagar, near Kalavati Hospital, Warasiya Ring Road, Vadodara, Gujarat 390006 India |
|
|
Primary Sponsor
|
| Name |
Nil |
| Address |
Nil |
| Type of Sponsor |
Other [Nil] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 7 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Gaurav Gadhvi |
Akshar Gynec Hospital |
Shaneshwar Temple, Desai Vago
Kheda
GUJARAT |
6352724288
info@aksharhospitals.com |
| Dr Jagan Mazmudar |
CHARUSAT Health Care & Research Foundation |
CHARUSAT Campus off Nadiad Petlad Highway Changa
Anand
GUJARAT |
02697-265502
coo.ch@charusat.ac.in |
| Dr Anil Gajjar |
Chaturbhai Gangadas General Hospital |
Charotar Medical Relief Society Opposite Yash Papad near Bus Stand Uttarsanda
Kheda
GUJARAT |
7069882113
cggeneral_hospital@outlook.com |
| Dr Sanjay Brahmbhatt |
Himalaya Hospital |
Bachapan School near Indira Gandhi Statue
Anand
GUJARAT |
7859954443
cashlesshimalaya@gmail.com |
| DrJayant Kumar Doshi |
Kashiben Gordhandas Patel Children Hospital |
Jalaram Marg, Karelibaug, Vadodara–390018, Gujarat, India;
Vadodara
GUJARAT |
0265 2463906
kgpchospital1984@yahoo.com |
| Dr Arun Vyas |
N. D. Desai Faculty of Medical Science & Research |
Dharmsinh Desai University College Road
Kheda
GUJARAT |
9979052500
dean.medical@ddu.ac.in |
| Dr Neeta Rangwani |
Neeta Maternity & Gynec Hospital |
C-3/B-5, Dayal Nagar near Kalavati Hospital Warasiya Ring Road
Vadodara
GUJARAT |
9898276715
neetamaternity@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee IEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O94||Sequelae of complication of pregnancy, childbirth, and the puerperium, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Midwife led counselling programme |
The Midwife-Led Counselling Programme is a 21-day structured intervention designed to reduce tocophobia (fear of childbirth) among pregnant women. The programme combines interactive in-person counselling sessions, telephonic follow-ups, and guided home-based activities. Counselling focuses on understanding childbirth fears, debunking myths, developing coping skills, and fostering a positive childbirth mindset. Activities such as letter writing to the unborn baby, progressive muscle relaxation, birth visualization, and affirmation exercises promote emotional connection, relaxation, and self-efficacy. The intervention emphasizes holistic antenatal support, birth preparedness, and postpartum self-care to enhance maternal confidence and wellbeing. |
| Comparator Agent |
NA |
NA |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Who is Primigravida
Age is between 21 to 35 years
Singleton pregnancy
Having a gestational week between 18 to 22 weeks
Who is Having Child Birth Fear
|
|
| ExclusionCriteria |
| Details |
Who is Conceived through ART
Who is diagnosed with the high-risk condition.
Who is diagnosed with any medical & surgical condition.
Who is having the Psychiatric Problem
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Significant change in Level of Tocophobia |
1 week from the day of Recruitment Primary Assessment
Week 2 & 3 is For Intervention
Week 4 is Post test
Note: 1 week pretest time plus 1 week post test time is considered for assessment of Pregnant women as all study participants may not be available at Given point of Time |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
05/03/2026 |
| 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="0"
Months="6"
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
|
This randomized controlled trial aims to evaluate the effect of a Midwife-Led Counselling Programme on tocophobia (fear of childbirth) among pregnant women attending selected hospitals of Central Gujarat. The intervention includes structured counselling sessions led by trained midwives, focusing on understanding childbirth, coping with labour pain, relaxation techniques, and emotional preparedness for delivery. Participants will be randomly assigned to either the intervention group receiving the midwife-led counselling programme or the control group receiving routine antenatal care..The primary outcome is the reduction in fear of childbirth.The study seeks to determine whether midwife-led counselling can serve as an effective, low-cost strategy to reduce tocophobia and promote positive childbirth experiences among pregnant women in Central Gujarat. |