| CTRI Number |
CTRI/2025/09/094648 [Registered on: 11/09/2025] Trial Registered Prospectively |
| Last Modified On: |
30/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
"Understanding How Women with Endometriosis Cope with Pain and How It Affects Their Daily Life: A Study from a Hospital in Bhopal" |
|
Scientific Title of Study
|
A descriptive study to assess the impact of Pain Cognition on the daily functioning of women diagnosed with Endometriosis in tertiary care hospital of Bhopal |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Suhani Mittal |
| Designation |
M.Sc. nursing Student |
| Affiliation |
All India Institute of Medical Sciences Bhopal |
| Address |
Dept of obstetrics and Gynaecological nursing, Nursing college, AIIMS Bhopal, Madhya Pradesh
Bhopal
Madhya Pradesh
462020
India
Bhopal
MADHYA PRADESH
462020
India |
| Phone |
8739810382 |
| Fax |
|
| Email |
suhani.mscnursing2024@aiimsbhopal.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Naseema Shafqat |
| Designation |
Assistant professor |
| Affiliation |
All India Institute of Medical Sciences Bhopal |
| Address |
Dept of obstetrics and Gynaecological nursing, Nursing college, AIIMS Bhopal, Madhya Pradesh,462020, India
Bhopal
MADHYA PRADESH
462020
India |
| Phone |
9907116675 |
| Fax |
|
| Email |
naseema.nursing@aiimsbhopal.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Naseema Shafqat |
| Designation |
Assistant professor |
| Affiliation |
All India Institute of Medical Sciences Bhopal |
| Address |
Dept of obstetrics and Gynaecological nursing, Nursing college, AIIMS Bhopal, Madhya Pradesh,462020, India
Bhopal
MADHYA PRADESH
462020
India |
| Phone |
9907116675 |
| Fax |
|
| Email |
naseema.nursing@aiimsbhopal.edu.in |
|
|
Source of Monetary or Material Support
|
| Self-Funded, AIIMS Bhopal, 462020 India |
|
|
Primary Sponsor
|
| Name |
Suhani Mittal |
| Address |
Dept of obstetrics and Gynaecological nursing, Nursing college, AIIMS Bhopal, Madhya Pradesh
Bhopal
Madhya Pradesh
462020
India |
| Type of Sponsor |
Other [Self funded] |
|
|
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 Naseema Shafqat |
All India Institute of Medical Sciences Bhopal |
Nursing College, All India Institute of medical Sciences, Bhopal Madhya Pradesh
Bhopal
MADHYA PRADESH |
9907116675
naseema.nursing@aiimsbhopal.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committe-Student Research(IHEC-SR) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N809||Endometriosis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1) Women diagnosed with endometriosis, confirmed through clinical diagnosis and medical records.
2) Women belonging to reproductive age group(15-45)years
3) Women who can understand, read, speak and write either Hindi or English language
4) Willing to participate and provide informed consent.
5) Women who are receiving care at the tertiary care hospital in Bhopal.
|
|
| ExclusionCriteria |
| Details |
1) Women with a history of other chronic pain conditions (e.g., fibromyalgia, irritable bowel syndrome) or any serious comorbidities (e.g., cancer, neurological disorders)that might interfere with the assessment of pain specific to endometriosis.
2) Women diagnosed with psychiatric disorders (e.g., severe depression, anxiety, or psychosis) that could affect their perception of pain cognition or daily functioning.
3) Women who are pregnant or breastfeeding.
4) Women who have undergone surgical treatment for endometriosis (such as hysterectomy) in the past 6 months.
5) Women receiving intensive Pain medications or interventions that can alter Pain perceptions.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1) To assess the cognitive Perception of Pain among women diagnosed with endometriosis.
2) To evaluate the current level of daily functioning among women of diagnosed with endometriosis
|
12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) To find out the correlation between Pain cognition and level of daily functioning among women diagnosed with endometriosis.
2) To explore the coping mechanism used by women to manage Pain.
3) To find out the association between pain cognition and selected socio-demographic variables among women diagnosed with endometriosis.
|
12 months |
|
|
Target Sample Size
|
Total Sample Size="115"
Sample Size from India="115"
Final Enrollment numbers achieved (Total)= "115"
Final Enrollment numbers achieved (India)="115" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
11/09/2025 |
| Date of Study Completion (India) |
12/09/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
05/11/2025 |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
Modification(s)
|
This study aims to assess the impact of pain cognition on the daily functioning of women diagnosed with endometriosis in a tertiary care hospital in Bhopal. Using a combination of sociodemographic and clinical data, the research will explore how factors like pain anxiety, catastrophizing, and pain intensity affect everyday activities such as work, social interactions, and self-care. Through validated tools like the Pain Catastrophizing Scale (PCS), Pain Anxiety Symptoms Scale (PASS), SF-36, EHP-30, and DASI, the study will analyze relationships between pain cognition, daily functioning, and sociodemographic variables. The findings will help identify key predictors of daily functioning and offer insights into personalized treatment approaches that address both the physical and psychological aspects of endometriosis. |