| CTRI Number |
CTRI/2025/07/091082 [Registered on: 17/07/2025] Trial Registered Prospectively |
| Last Modified On: |
06/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect Of A Holistic Intervention And Caregiver Support On Adolescent Girls With Primary Dysmenorrhea |
|
Scientific Title of Study
|
Impact Of Multimodal Intervention On Adolescent Girls With Primary Dysmenorrhea Along With Caregiver Support: A Randomized Controlled 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 |
Harshitha V K |
| Designation |
Post Graduate Student |
| Affiliation |
Nitte Institute Of Physiotherapy |
| Address |
Medical Science Complex, Post Nithyananda Nagar, Deralakatte, Mangaluru
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9964412923 |
| Fax |
|
| Email |
harshitha.24ptms11@student.nitte.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Ms Ruchita Narsia |
| Designation |
Assistant Professor Grade II |
| Affiliation |
Nitte Institute Of Physiotherapy |
| Address |
Medical Science Complex, Post Nithyananda Nagar, Deralakatte, Mangaluru
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9408956388 |
| Fax |
|
| Email |
ruchita.narsia@nitte.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Ms Ruchita Narsia |
| Designation |
Assistant Professor Grade II |
| Affiliation |
Nitte Institute Of Physiotherapy |
| Address |
Medical Science Complex, Post Nithyananda Nagar, Deralakatte, Mangaluru
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9408956388 |
| Fax |
|
| Email |
ruchita.narsia@nitte.edu.in |
|
|
Source of Monetary or Material Support
|
| Nitte Institute of Physiotherapy |
|
|
Primary Sponsor
|
| Name |
Nitte Institute of Physiotherapy |
| Address |
Nitte Institute of Physiotherapy, Nitte Deemed to be University, Nithyananda Nagar, Deralakatte, Mangaluru, Dakshina Kannada, Karnataka 575018, India |
| Type of Sponsor |
Private medical college |
|
|
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 |
| Harshitha V K |
Nitte Institute of Physiotherapy |
Nitte Institute of Physiotherapy, Nitte Deemed to be University, Nithyananda Nagar, Deralakatte, Mangaluru, Dakshina Kannada, Karnataka 575018, India
Dakshina Kannada
KARNATAKA |
9964412923
harshitha.24ptms11@student.nitte.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee of Nitte Institute of Physiotherapy |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Primary Dysmenorrhea
|
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control Group—Education and Management on Primary Dysmenorrhea through Pamphlet |
The participants will receive an educational pamphlet regarding dysmenorrhea education and management in the beginning of the study and advised to follow the intervention for dysmenorrhea for up to 3 menstrual cycles. Baseline data will be collected using the WaLIDD score and EQ-5D. Participants will then be asked to complete the post-intervention WaLIDD score after each menstrual cycle. Participants will complete a final post-intervention WaLIDD score and EQ-5D after three menstrual cycles. |
| Intervention |
Multimodal Intervention Program for the Management of Primary Dysmenorrhea with Caregiver Support |
Group sessions will be provided by the investigator for thirty to fifty minutes. The program begins with an education session, followed by weekly group sessions held three times a week on alternate days for three months.
A new intervention will be introduced every two weeks. The intervention consists of three stages (including education) and a five-phase management plan. It is implemented before and during menstruation. Dysmenorrhea education and its management sessions are tailored to the convenience of both the participants and the school and will be conducted at their respective schools, including both the child and the caregiver for the first and last sessions.
Overall, for the intervention, three sessions of thirty to fifty minutes each will be conducted every week for 12 weeks on alternate days.
In the first session of Week 1 and the first session of Week 11, both the caregiver and the child will be included in the education on dysmenorrhea and its multimodal intervention. In the other sessions, only the child will undergo the interventions. The caregiver will be present during these key sessions to gain a better understanding of the process, enabling her to support her child effectively and assist in implementing the intervention at home.
The intervention sessions include:
Stage 1: Building the Foundation (Weeks 1–4)
Weeks 1–2 (30 minutes):
Education sessions on dysmenorrhea, symptoms, and self-management strategies (20 minutes in Week 1, reduced to 10 minutes in Week 2).
General stretching exercises (neck, shoulders, arms, wrists, hips, thighs) for flexibility and pain relief.
Weeks 3–4 (30–40 minutes):
Reinforcement of dysmenorrhea education.
Continued general stretching, with the addition of specific muscle stretches (iliopsoas, adductors, hamstrings).
Stage 2: Expanding the Program (Weeks 5–8)
Weeks 5–6 (30–40 minutes):
Introduction of yoga-based postures (Baddha Konasana, Balasana, Surya Namaskara) alongside stretching routines.
Weeks 7–8 (40–45 minutes):
Pelvic floor muscle contractions (slow, rapid, and ascending contractions) introduced for core strengthening.
Stage 3: Integration and Reinforcement (Weeks 9–12)
Weeks 9–10 (45–50 minutes):
Relaxation techniques (diaphragmatic breathing) incorporated to manage stress-related symptoms.
Weeks 11–12 (50–55 minutes):
Full implementation of the five-phase intervention on alternate days, ensuring adherence and caregiver involvement for continued support.
Baseline data will be collected using the WaLIDD score and EQ-5D. Participants will then be asked to complete the post-intervention WaLIDD score after each menstrual cycle. After completing all dysmenorrhea education and management sessions (i.e., after 12 weeks), participants will complete a final post-intervention WaLIDD score and EQ-5D after three menstrual cycles. |
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
16.00 Year(s) |
| Gender |
Female |
| Details |
1)Adolescent girls aged 12 to 16 years.
2)Adolescent girls with Moderate – Severe menstrual pain on WaLIDD score.
3)Participants should have a history of regular menstrual cycles (every 21 to 35
days) for at least three months prior to the study.
4)Education level of the caregiver.
5)A willingness of the adolescent girl to take part in the research.
6)Willingness of mothers or primary female caregivers to participate in the
educational and exercise component of the intervention.
|
|
| ExclusionCriteria |
| Details |
1)Adolescent girls who are not willing to participate in the study.
2)Girls with dysmenorrhea resulting from identifiable medical conditions (e.g.,
endometriosis, pelvic inflammatory disease, uterine fibroids) will be excluded.
3)Participants who have engaged in other treatments for dysmenorrhea (such
as alternative therapies) within the last three months prior to the study.
4)Girls currently using hormonal contraceptives or other medications that affect
menstrual symptoms.
5)Physical limitations that would prevent participation in stretching, exercise, or
yoga components of the intervention. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| WaLIDD Score |
The WaLIDD score will be recorded at baseline and then after each menstrual cycle following each monthly intervention session, for a total of three cycles |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| EQ-5D |
The EQ-5D will be assessed at baseline and at 12 weeks, that is, upon completion of the intervention following the final menstrual cycle. The pre and post scores will be then evaluated. |
|
|
Target Sample Size
|
Total Sample Size="52"
Sample Size from India="52"
Final Enrollment numbers achieved (Total)= "52"
Final Enrollment numbers achieved (India)="52" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
01/08/2025 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
27/12/2025 |
|
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
|
Primary dysmenorrhea, affecting 50%–87.8% of adolescent girls in India, causes significant pain and disrupts daily activities and quality of life. Despite its high prevalence, it is often poorly managed due to a lack of awareness, stigma, and misconceptions, with many girls enduring symptoms silently. Caregivers, especially mothers, greatly influence how girls perceive and manage menstrual pain, yet they often have limited or incorrect knowledge.
This study aims to evaluate the effectiveness of a multimodal intervention combining education, lifestyle modifications, and non-pharmacological strategies to reduce dysmenorrhea symptoms, while also assessing the impact of caregiver support. Participants will be divided into an experimental group (receiving structured sessions with caregiver involvement) and a control group (receiving pamphlet-based education only). By actively involving caregivers and educating both groups, the study seeks to improve symptom management and enhance the overall quality of life of adolescent girls. |