Yoga for Primary Dysmenorrhea among Adolescent girls of Ranchi Jharkhand

Recruiting

• Conditions: Primary dysmenorrhea,

• Registration Number: CTRI/2024/06/068323
• Lead Sponsor: NA

Brief Summary

Introduction:Primary dysmenorrhea refers to cyclic menstrual pain without an identifiableunderlying pathology. This common condition is characterized by cramping duringmenstruation, often accompanied by symptoms like low backache, nausea,vomiting, headache, or diarrhea. Prostaglandins play a role in dysmenorrhea bystimulating myometrial contractions and causing ischemia. Despite itsprevalence, dysmenorrhea can significantly impact physical and mentalwell-being.

Empirictherapy, including NSAIDs, oral contraceptives, and other medications, iscommonly 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.

Thestudy aims to assess the effect of yoga on menstrual distress among adolescentgirls suffering from primary dysmenorrhea. Additionally, it aims to addressknowledge gaps related to menstrual and reproductive health in this population.

Aim:Alleviate menstrual distress and improve overall menstrual health in adolescentgirls.

PrimaryObjective: Evaluate the impact of yoga intervention using the MenstrualDistress Questionnaire (MDQ).

Materialsand Methods:

StudyDesign: Randomized Controlled Trial

StudySite: Government high school in Ranchi

StudyPopulation: Adolescent girls (class 8th to 10th) with primary dysmenorrhea fromgovernment and private high schools.

Inclusioncriteria:

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 VAS

3. Having menstrual cycle of 24-38 days with regularity by which no. of days varies ≤ 7-9 days

4. Menstrual bleeding phase of ≤ 8 days

5. Volume of bleed <100 points on Pictorial Blood Assessment Chart (PBAC)

Exclusion criteria:

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.

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 citygovernment  1 school will be selected by Simple Random sampling. Well-informedassent will be taken from the pupils, parents and head of the school prior tothe study. Participantsfor the study will be selected as per eligibility criteria, Randomallocation will be done using Block Randomization for fixed block sizes intoparticipant population/ Intervention group and non- participant / control group, base linedata by pre tested questionnaire will be collected from both the groups. Yoga as an intervention will be given to theintervention group for 3 months period 5 times in a week for a duration of30-40 mins daily depending on the phase of menstrual cycle the participants arein (according to pre designed verified yoga protocol) preferably at the sametime of the day.

Yogagiven 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 necessarytests of significance will be applied to prove the findings statisticallysignificant.

Data entry and record will be maintained in Excel sheets using MS Excel and data analysis will be done by IBM SPSS softwareversion 20.0

Detailed Description

Not available

Study Timeline

• Study Start: 2024-06-15
• Last Update Posted: 2024-06-25

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Female
• Target Recruitment: 250

Inclusion Criteria

• 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.

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Measures

Name	Time	Method
Reduction in school absenteeism after intervention	10 months after the starting of intervention

Trial Locations

Locations (1)

Tikait Umrao Singh Sheikh Bhikhari Project Balika High School; 🇮🇳 Ranchi, JHARKHAND, India

Tikait Umrao Singh Sheikh Bhikhari Project Balika High School

🇮🇳Ranchi, JHARKHAND, India

Dr Apoorva Wasnik

Principal investigator

9907639993

apoorva51191@gmail.com