| CTRI Number |
CTRI/2025/08/092667 [Registered on: 08/08/2025] Trial Registered Prospectively |
| Last Modified On: |
05/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Comparing Billig’s Exercise and Hot Water Application to Reduce Menstrual Pain in Teenage Girls at a Selected High School |
|
Scientific Title of Study
|
Effectiveness of billigs exercise Vs plain hot water application in reducing primary dysmenorrhoea among adolescent girls at selected high school |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
pranjali Saranjami Jode |
| Designation |
POST GRADUATE STUDENT |
| Affiliation |
DATTA MEGHE INSTITUTE OF HIGHER EDUCATION AND RESEARCH |
| Address |
Department of community health nursing Smt. Radhikabai Meghe Memorial College of Nursing, Sawangi (Meghe), Wardha, India, Maharashtra
Wardha
MAHARASHTRA
442001
India |
| Phone |
09637073836 |
| Fax |
|
| Email |
pranjalijode@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Deeplata Mendhe |
| Designation |
HOD cum Professor |
| Affiliation |
DATTA MEGHE INSTITUTE OF HIGHER EDUCATION AND RESEARCH |
| Address |
Department of community health nursing Smt. Radhikabai Meghe Memorial College of Nursing, Sawangi (Meghe), Wardha, India, Maharashtra
Wardha
MAHARASHTRA
442001
India |
| Phone |
9527538397 |
| Fax |
|
| Email |
mendhedeeplata@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Deeplata Mendhe |
| Designation |
HOD cum Professor |
| Affiliation |
DATTA MEGHE INSTITUTE OF HIGHER EDUCATION AND RESEARCH |
| Address |
Department of community health nursing Smt. Radhikabai Meghe Memorial College of Nursing, Sawangi (Meghe), Wardha, India, Maharashtra
Wardha
MAHARASHTRA
442001
India |
| Phone |
9527538397 |
| Fax |
|
| Email |
mendhedeeplata@gmail.com |
|
|
Source of Monetary or Material Support
|
| DATTA MEGHE INSTITUTE OF HIGHER EDUCATION AND RESEARCH SAWANGI MENGHE WARDHA INDIA 442001 |
|
|
Primary Sponsor
|
| Name |
DATTA MEGHE INSTITUTE OF HIGHER EDUCATION AND RESEARCH |
| Address |
SAWANGI MENGHE WARDHA INDIA 442001 |
| 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 |
| Pranjali Saranjami Jode |
Smt Radhikabai Meghe Memorial college of nursing |
Department of community health nursing ground floor Smt Radhikabai Meghe Memorial college of nursing
Wardha
MAHARASHTRA |
09637073836
pranjalijode@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee, Datta meghe higher education and research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N944||Primary dysmenorrhea, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Billigs exercise |
Billigs exercise is a non-pharmacological approach to managing primary dysmenorrhea, which is painful menstruation, in adolescent girls. It involves specific exercises that focus on strengthening and stretching muscles in the pelvic and lower back area |
| Comparator Agent |
Plain hot water application |
Applying plain hot water to the lower abdomen can help relax muscles and reduce menstrual cramps. This simple heat therapy increases blood flow and eases pain associated with dysmenorrhea. |
|
|
Inclusion Criteria
|
| Age From |
11.00 Year(s) |
| Age To |
21.00 Year(s) |
| Gender |
Female |
| Details |
Willing to participate
Who understand the Marathi and English language.
Adolescent girls between the age group 12 + 18 years
Only adolescent girls who experience menstrual pain could be included in a study on dysmenorrhea treatments. Having the moderate to severe Dysmenorrhea.
|
|
| ExclusionCriteria |
| Details |
Girls with conditions such as polycystic ovary syndrome (PCOS) or endometriosis |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Visual analog scale for pain assessment |
At baseline Days 1 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Dysmenorrhea symptom interference |
Day 7 |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
01/09/2025 |
| 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="6"
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
|
Effectiveness of billig’s exercise vs plain hot water application in reducing primary dysmenorrhoea among adolescent girls at selected high school present study will help to find the better treatment availability for dysmenorrhea problem among adolescent girls
|