| CTRI Number |
CTRI/2026/02/103926 [Registered on: 16/02/2026] Trial Registered Prospectively |
| Last Modified On: |
14/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Experiences about menstrual pain in women with pelvic pain |
|
Scientific Title of Study
|
Perspectives of women with endometriosis-associated dysmenorrhea on pain management: A Exploratory Qualitative 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 |
Shruthi |
| Designation |
MPT student |
| Affiliation |
Manipal College of Health Professions |
| Address |
Department of Physiotherapy Second Floor, Manipal College of Health Professions, Manipal Academy of Higher Education, Madhav Nagar, Manipal- 576104 Udupi Karnataka 576104 India
Udupi
KARNATAKA
576104
India |
| Phone |
8971047213 |
| Fax |
|
| Email |
shruthi.mchpmpl2025@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Preetha R |
| Designation |
Associate Professor |
| Affiliation |
Manipal College of Health Professions |
| Address |
Room no 211 Department of Physiotherapy Second Floor, Manipal College of Health Professions, Manipal Academy of Higher Education, Madhav Nagar, Manipal- 576104 Udupi Karnataka 576104 India
Udupi
KARNATAKA
576104
India |
| Phone |
9945670669 |
| Fax |
|
| Email |
preetha.r@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Mrs Anupama Prabhu |
| Designation |
Assistant Professor |
| Affiliation |
Manipal College of Health Professions |
| Address |
Department of Physiotherapy Second Floor, Manipal College of Health Professions, Manipal Academy of Higher Education, Madhav Nagar, Manipal- 576104 Udupi Karnataka 576104 India
Udupi
KARNATAKA
576104
India |
| Phone |
9986451010 |
| Fax |
|
| Email |
anupama.prabhu@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Room no 211 Department of Physiotherapy Second floor, Manipal College of Health Professions Manipal Academy of Higher Education Madhav Nagar Manipal-576104 |
|
|
Primary Sponsor
|
| Name |
Manipal College of Health Professions |
| Address |
Manipal College of Health Professions Manipal Academy of Higher Education Madhav Nagar-576104 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Ms Shruthi |
Manipal Academy of Higher Education |
Women and Children Block, Ground floor OPD near the scan room, Kasturba Hospital, Manipal-576104 Udupi Karnataka
Udupi
KARNATAKA |
8971047213
shruthi.mchpmpl2025@learner.manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: PCS||, (2) ICD-10 Condition: N711||Chronic inflammatory disease of uterus, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Clinical or laparoscopic diagnosis of endometriosis by clinician
Women aged between 18-45 years with experience of dysmenorrhea
Ability to speak and understand English or Kannada
|
|
| ExclusionCriteria |
| Details |
Pregnant woman or postpartum woman less than 6 months
Previous gynecological surgeries(oophorectomy, salpingectomy)
Any known neurologic, genitourinary, gastrointestinal disease including irritable bowel syndrome |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
The primary outcome of this qualitative study is to explore and understand the perceptions, experiences, beliefs and challenges related to pain management in women with endometriosis-associated dysmenorrhea. Specifically , it aims to capture participants self-reported perspectives on pain management who is having endometriosis-associated dysmenorrhea
|
Data will be collected at a single time point through an in-depth interview of women with endometriosis- associated dysmenorrhea. Each participant will undergo one interview session lasting approximately 30-45 minutes. No follow up sessions are planned as the study is cross sectional and exploratory in nature
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
NA |
|
|
Target Sample Size
|
Total Sample Size="15"
Sample Size from India="15"
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)
|
15/03/2026 |
| 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="10"
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 is on women who are having endometriosis-associated dysmenorrhea will be taken for face to face in-depth interview. Patient will be screened on the mentioned inclusion and exclusion criteria. Face-to-face interview will be conducted in Kannada or English language and audio recording will be done. Converting the audio recording into codes. Coding will be done based on following stages transcription, familiarization with the interview, coding, developing an analytical framework, applying the analytical framework, charting data into framework matrix, interpreting the data. |