| CTRI Number |
CTRI/2024/03/063915 [Registered on: 11/03/2024] Trial Registered Prospectively |
| Last Modified On: |
27/02/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Prevalence of Tokophobia among pregnant women electing for Normal Vaginal Delivery and Cesarean-Section |
|
Scientific Title of Study
|
PREVALENCE OF TOKOPHOBIA AMONG PREGNANT WOMEN ELECTING FOR NORMAL VAGINAL DELIVERY(NVD) AND CAESAREAN-SECTION: A CROSS-SECTIONAL STUDY
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Isha |
| Designation |
BPT student |
| Affiliation |
Maharishi Markandeshwar Medical College and Hospital |
| Address |
Maharishi Markandeshwar Medical College and Hospital, Orthopedics Department, Physiotherapy OPD, Room number 510, Kumarhatti, Solan, HP
Solan
HIMACHAL PRADESH
173229
India |
| Phone |
7876312931 |
| Fax |
|
| Email |
waliaisha74@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pooja Mehra |
| Designation |
Assistant professor |
| Affiliation |
Maharishi Markandeshwar Medical College and Hospital |
| Address |
Maharishi Markandeshwar Medical College and Hospital, Orthopedics Department, Physiotherapy OPD, Room number 510, Kumarhatti, Solan, HP
Solan
HIMACHAL PRADESH
173229
India |
| Phone |
9896644741 |
| Fax |
|
| Email |
mehra.drpooja@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Geetanjali Kaul |
| Designation |
Assistant professor |
| Affiliation |
Maharishi Markandeshwar Medical College and Hospital |
| Address |
Maharishi Markandeshwar Medical College and Hospital, Orthopedics Department, Physiotherapy OPD, Room number 510, Kumarhatti, Solan, HP
Solan
HIMACHAL PRADESH
173229
India |
| Phone |
7018518005 |
| Fax |
|
| Email |
drgeetanjalikaul@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maharishi Markandeshwar Medical College and Hospital Kumharhatti,Solan |
|
|
Primary Sponsor
|
| Name |
Isha |
| Address |
Maharishi Markandeshwar College and Hospital Kumharhatti, Solan |
| Type of Sponsor |
Other [Self] |
|
|
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 Pooja Mehra |
Physiotherapy OPD |
Department of Orthopaedics, Physiotherapy OPD, Room no- 510, Maharishi Markandeshwar Medical College and Hospital Kumarhatti, Solan
Solan
HIMACHAL PRADESH |
9896644741
mehra.drpooja@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee MMMC&H, Kumarhatti, Solan |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
healthy pregnant females |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
Age group between 18 – 35 years
Pregnant women
Able to understand English and Hindi
|
|
| ExclusionCriteria |
| Details |
Previous gynecological surgery
Less than 18 year
Psychological disorder
Non-coperative patient
Haemodynamic unstable
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Wijma Delivery Expectancy Questionnaire Version-a |
one time measurement |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Numeric Pain Rating Scale |
baseline |
|
|
Target Sample Size
|
Total Sample Size="230"
Sample Size from India="230"
Final Enrollment numbers achieved (Total)= "230"
Final Enrollment numbers achieved (India)="230" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
17/03/2024 |
| Date of Study Completion (India) |
14/05/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
NO |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Pregnancy and delivery is a natural phenomenon in women life and becoming a mother is one of the most important achievement in women’s life. Pregnant women may experience fear, anxiety, discomfort, worry, depression or even fear of dying when thinking about her delivery. Most of the time women who are getting pregnant for the first time experiences stress and anxiety which is a pathological fear of childbirth. Because of this some women may chose cesarean section over normal delivery. Fear of childbirth in multiparous women can be because of previous traumatic experiences from the delivery. Previous literature mainly focus on the prevalence of Tokophobia among primigravida or multigravida women. In India, till date there is no literature available which find out the prevalence of Tokophobia among pregnant female opting for Normal Vaginal delivery and Cesarean -section. Therefore, the purpose of this study is to find out the prevalence of Tokophobia among pregnant women electing for Normal Vaginal Delivery and Cesarean-Section and to prevent the fear of childbirth. |