CTRI Number |
CTRI/2024/06/068323 [Registered on: 04/06/2024] Trial Registered Prospectively |
Last Modified On: |
31/07/2025 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Yoga & Naturopathy |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
|
Yoga for Primary Dysmenorrhea among Adolescent girls of Ranchi Jharkhand |
Scientific Title of Study
|
To Study the Effect of Yoga on Menstrual Distress among Adolescent Girls with Primary Dysmenorrhea: A Randomized Controlled Trial in Ranchi, Jharkhand |
Trial Acronym |
Not Applicable |
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Apoorva Wasnik |
Designation |
Junior Resident Academics |
Affiliation |
Rajendra Institute of Medical Sciences |
Address |
Department of PSM, 4th floor, Rajendra Institute of Medical Sciences, Ranchi
Ranchi JHARKHAND 834009 India |
Phone |
9907639993 |
Fax |
|
Email |
apoorva51191@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr. Mithilesh Kumar |
Designation |
Additional Professor |
Affiliation |
Rajendra Institute of Medical Sciences, Ranchi |
Address |
Department of PSM, 4th Floor, Rajendra Institute of Medical Sciences, Ranchi, Jharkhand
Ranchi JHARKHAND 834009 India |
Phone |
9835808310 |
Fax |
|
Email |
mithilesh2576@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Mithilesh Kumar |
Designation |
Additional Professor |
Affiliation |
Rajendra Institute of Medical Sciences, Ranchi |
Address |
Department of PSM, 4th Floor, Rajendra Institute of Medical Sciences, Ranchi
Ranchi JHARKHAND 834009 India |
Phone |
9835808310 |
Fax |
|
Email |
mithilesh2576@gmail.com |
|
Source of Monetary or Material Support
|
Rajendra Institute of Medical Sciences, Ranchi
834009
Jharkhand
India |
|
Primary Sponsor
|
Name |
NA |
Address |
NA |
Type of Sponsor |
Other [nil] |
|
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 Apoorva Wasnik |
Tikait Umrao Singh Sheikh Bhikhari Project Balika High School |
Indoor room 1, Shastri Block Chowk, Ormanjhi, Ranchi, 835219 Ranchi JHARKHAND |
9907639993
apoorva51191@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 2 |
Name of Committee |
Approval Status |
Institutional Ethics Committee RIMS Ranchi |
Approved |
Tikait Umrao Singh Sheikh Bhikhari Project Balika High School |
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 |
Comparator Agent |
No Intervention given to the Comparator group |
The baseline and follow up data collection will be done from the comparator group at the starting and then again at the end of 4 months.
No active intervention given to them as they naturally are not taking any treatment for the condition.
|
Intervention |
Yoga Asna |
Following yoga asna will be given to the participants During Menstrual bleeding phase:
Pranayama
Yogic sukshma vyayamas/loosening exercises
Marjaryasana-Bitilasana/ cat-cow pose
Baddha konasana /butterfly pose
Supta Baddha Konasana/ goddess pose
Bhujangasan/cobra pose
Balasana/child pose
Yoga Nidra /Savasan
Intervention will be given for 4 months period 5 times in a week for a duration of 30-40 mins daily.
|
|
Inclusion Criteria
|
Age From |
11.00 Year(s) |
Age To |
17.00 Year(s) |
Gender |
Female |
Details |
1. Adolescent girls of class 8th to 10th already attained menarche and willing to participate in the study
2. Menstrual pain grading of 3 to 8 on visual analogue scale
3. Having menstrual cycle of 24 to 38 days with regularity by which no. of days varies less than equal to 7-9 days
4. Menstrual bleeding phase of less than equal to 8 days
5. Volume of bleed less than 100 points on Pictorial Blood Assessment Chart PBAC.
|
|
ExclusionCriteria |
Details |
1. Any pre diagnosed Gynecological condition leading to Secondary dysmenorrhea
2. Already performing Yogic asanas
3. Taking regular medications for Menstrual cramps
4. Any Musculo skeletal disability restricting the intervention.
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Outcome Assessor Blinded |
Primary Outcome
|
Outcome |
TimePoints |
Change in menstrual distress as measured by Menstrual Distress Questionnaire by change in Mean VAS ( Visual Analogue Scale) score after the intervention of yoga. |
end of 4months of intervention |
|
Secondary Outcome
|
Outcome |
TimePoints |
Reduction in school absenteeism after intervention |
10 months after the starting of intervention |
|
Target Sample Size
|
Total Sample Size="250" Sample Size from India="250"
Final Enrollment numbers achieved (Total)= "254"
Final Enrollment numbers achieved (India)="254" |
Phase of Trial
|
N/A |
Date of First Enrollment (India)
|
15/06/2024 |
Date of Study Completion (India) |
31/01/2025 |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
|
Years="0" Months="4" 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)
|
Introduction:
Primary dysmenorrhea refers to cyclic menstrual pain without an identifiable
underlying pathology. This common condition is characterized by cramping during
menstruation, often accompanied by symptoms like low backache, nausea,
vomiting, headache, or diarrhea. Prostaglandins play a role in dysmenorrhea by
stimulating myometrial contractions and causing ischemia. Despite its
prevalence, dysmenorrhea can significantly impact physical and mental
well-being. Empiric
therapy, including NSAIDs, oral contraceptives, and other medications, is
commonly used for management. Non-pharmacological approaches such as exercise,
acupuncture, and yoga have also been studied. Yoga, with its holistic approach,
may not only alleviate menstrual pain but also improve overall health. The
study aims to assess the effect of yoga on menstrual distress among adolescent
girls suffering from primary dysmenorrhea. Additionally, it aims to address
knowledge gaps related to menstrual and reproductive health in this population. Aim:
Alleviate menstrual distress and improve overall menstrual health in adolescent
girls. Primary
Objective: Evaluate the impact of yoga intervention using the Menstrual
Distress Questionnaire (MDQ). Materials
and Methods: Study
Design: Randomized Controlled Trial Study
Site: Government high school in Ranchi Study
Population: Adolescent girls (class 8th to 10th) with primary dysmenorrhea from
government and private high schools. Inclusion
criteria:
- Adolescent
girls of class 8th to 10th already
attained menarche and willing to participate in the study
- Menstrual pain grading of 3 to 8 on VAS
- Having menstrual cycle
of 24-38 days with regularity by which no. of days varies ≤ 7-9 days
- Menstrual bleeding
phase of ≤ 8 days
- Volume of bleed <100
points on Pictorial Blood Assessment Chart (PBAC)
Exclusion criteria:
- Any pre diagnosed Gynecological condition leading to Secondary
dysmenorrhea
- Already performing Yogic asanas
- Taking regular medications for Menstrual cramps
- Any Musculo skeletal disability restricting the intervention.
Sample size: Sample Size calculation: From the previous study Alpha=0.05 / Z(1-α/2) = 1.96 Power=0.80/Z (1-β) = 0.84 Delta=0.91(μ2-μ1) SD (σ) = 2.67 Equating the values into the formula: [{Z(1-α/2)+Z(1-β)}
× (2σ)2] / (μ2-μ1)2 Sample Size in number:125 per group
/ 250 total Method of Sample collection: Out of all the schools of the Ranchi city
government 1 school will be selected by Simple Random sampling. Well-informed
assent will be taken from the pupils, parents and head of the school prior to
the study. Participants
for the study will be selected as per eligibility criteria, Random
allocation will be done using Block Randomization for fixed block sizes into
participant population/ Intervention group and non- participant / control group, base line
data by pre tested questionnaire will be collected from both the groups. Yoga as an intervention will be given to the
intervention group for 3 months period 5 times in a week for a duration of
30-40 mins daily depending on the phase of menstrual cycle the participants are
in (according to pre designed verified yoga protocol) preferably at the same
time of the day. Yoga
given during menstrual bleeding phase
Pranayama
|
3 min
|
Yogic sukshma
vyayamas/loosening exercises
|
3 min
|
Marjaryasana-Bitilasana/
cat-cow pose
|
5 min
|
Baddha konasana
/butterfly pose
|
5 min
|
Supta Baddha
Konasana/ goddess pose
|
5 min
|
Bhujangasan/cobra
pose
|
5 min
|
Balasana/child
pose
|
5min
|
Yoga Nidra
/Savasan
|
6min
|
- Yoga
will be instructed by a certified instructor and
- a detailed booklet of
all the asanas to be performed will be distributed to each participant.
Participants will be instructed in the presence of school teachers/ PTs, accuracy of yoga being done will
be checked fortnightly by the instructor. Investigator
will be monitoring the intervention 2 to 3 times a week to check the
regularity.
- End point
data with the same questionnaire will be collected after the end of 4th month
of intervention at all the phases individually.
- Rescue
treatment for the participants will be provided if the pain or other
complications arise during the course of intervention and the particular
participant will be excluded from analysis.
Data collection and Statistical analysis: Both pre-intervention and post-intervention data will be collected. Baseline characteristics of both the group will be compared, drop out, lost to follow-up will be assessed. Per protocol, analysis will be done. All necessary
tests of significance will be applied to prove the findings statistically
significant.
Data entry and record will be maintained in Excel sheets using MS Excel and data analysis will be done by IBM SPSS software
version 20.0 |