| CTRI Number |
CTRI/2025/07/091849 [Registered on: 28/07/2025] Trial Registered Prospectively |
| Last Modified On: |
28/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Avoidance Of Negative Experience, Emotional Regulation, and Pain Sensitivity among Female Emerging Adults with Menstrual Pain. |
|
Scientific Title of Study
|
Role of Experiential Avoidance on Emotional Regulation and Pain Catastrophizing among female emerging adults with Dysmenorrhea |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rhea Malhotra |
| Designation |
Student |
| Affiliation |
Manipal College of Health Professions |
| Address |
Department of Clinical Psychology, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal 576104
Madhavanagar, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
09492197303 |
| Fax |
|
| Email |
rhea1.mchpmpl2024@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Anagha S Deshmukh |
| Designation |
Assistant Professor |
| Affiliation |
Manipal College of Health Professions |
| Address |
Department of Clinical Psychology, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal 576104
Madhavanagar, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
7259619947 |
| Fax |
|
| Email |
anagha.deshmukh@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Rhea Malhotra |
| Designation |
Student |
| Affiliation |
Manipal College of Health Professions |
| Address |
Department of Clinical Psychology, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal 576104
Madhavanagar, Manipal
KARNATAKA
576104
India |
| Phone |
09492197303 |
| Fax |
|
| Email |
rhea1.mchpmpl2024@learner.manipal.edu |
|
|
Source of Monetary or Material Support
|
| Manipal College of Health Professionals (MCHP),Manipal Academy of Higher Education (MAHE) Madhav Nagar, Eshwar Nagar, Manipal, Karnataka 576104 |
|
|
Primary Sponsor
|
| Name |
Rhea Malhotra |
| Address |
Department of Clinical Psychology, MCHP, MAHE, Manipal 576104 |
| 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 |
| Rhea Malhotra |
Manipal Academy of Higher Education |
Department of Clinical Psychology, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal 576104
Madhavanagar, Manipal
Udupi
KARNATAKA |
09492197303
rhea1.mchpmpl2024@learner.manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College & Kasturba Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Primary Dysmenorrhea |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
24.00 Year(s) |
| Gender |
Female |
| Details |
1) 18 to 24 years
2) Females
3) Women with primary dysmenorrhea and those who have a pain score of 1 or higher (on a scale from 0 to 5) on the Menstrual Pattern Questionnaire.
|
|
| ExclusionCriteria |
| Details |
1) Women diagnosed with secondary dysmenorrhea, including cases of Endometriosis, PCOS, or PCOD
2) Any current diagnosis of a psychiatric disorder
3) Severe history of mental health conditions
Participants scoring more than 25 on the Kessler Psychological Distress Scale (K10)
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To study the relationship between experiential avoidance, emotional regulation and pain catastrophizing in females emerging adults with dysmenorrhea
2. To study the moderating role of experiential avoidance on the relationship between emotional regulation and pain catastrophizing in females emerging adults with dysmenorrhea (weight and self-medication as covariates). |
Pain sensitivity will be assessed at baseline"
"Emotional regulation will be measured at baseline using the DERS scale. |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="168"
Sample Size from India="168"
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)
|
01/08/2026 |
| 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="7"
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 examine the role of experiential avoidance in the relationship between emotional regaulation and pain catastrophizing among female emerging adults experiencing primary dysmenorrhea. It is a cross-sectional, observational study that will be conducted both offline and online. Participants aged 18-24 years who meet the inclusion criteria will be recruited using convenience sampling. Data will be collected using standardized tools: The difficulties in Emotion Regulation Scale (DERS-16), Brief Experiential Avoidance Questionnaire (BEAQ-15), Pain Catastrophizing Scale (PCS) and Menstrual Pattern Questionnaire. This study will analyze whether experiential avoidance moderates the relationship between emotional dysregulation and pain catastrophizing. The findings are expected to contribute to the understanding of psychological coping stategies associated with dysmenorrhea and may have implications for mental health interventions and pain management practices among women |