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Effectiveness of Meditation and Yoga on painful Menstruation among adolescent girls

Not yet recruiting
Conditions
Adolescent girls those who are experiencing dysmenorrhea (2022 ICD-10-CM Diagnosis Code N94.6)
Registration Number
CTRI/2021/11/037703
Lead Sponsor
DSTSATYAM
Brief Summary

The proposed study is conducted in two phases. In the first phase, investigators will identify the prevalence of primary dysmenorrhea among the adolescent girls of the Udupi district. Two thaluks will be selected randomly from the Udupi district. From those two thaluks, the High schools and Pre-university colleges (both government and private) will be randomly selected as per the sample size calculation (≈5000 samples). The probability Proportionate Size (PPS) method will be adopted.

After obtaining permission from Principals and Headteachers of the High schools & Pre-university colleges, the assent will be sent to the parents along with the participant information sheet. Upon approval, the data will be collected on the prevalence of primary dysmenorrhea among adolescent girls by junior research fellow and field workers. Adolescent girls will be given the questionnaire on the prevalence of dysmenorrhea at the school level which will take 20 minutes of their time.

In Phase 2, the adolescent girls with high pain intensity (numerical pain rating scale ≥ 4) will be selected. The calculated sample size for the second phase of the study will be 200 in each group (treatment and control group). After obtaining assent from parents, data on the Numerical pain rating scale, Stress, Academic performance, perceived self-efficacy, and Bio-marker level will be assessed from both groups. Biomarkers (Hb, Prostaglandins, Estrogen & Progesterone) will be collected on the first day of the menstrual cycle, followed by a session of yoga and meditation conducted for a period of 45 minutes for 12 weeks. All the expenditures i.e., for yoga mat and biomarker study will be taken by the funding agency.  The intervention will be conducted at the school level,(as a cluster) during the school hours as per the slots allotted by the school administration.The intervention will take place 5 days a week and Sundays will be excluded. Yogaand Meditation intervention will not be performed for 3 days during menstruation as it can cause discomfort due to unbearable pain. They can continue with SOS medicine in case of unbearable pain.  Yogic intervention includes Loosening exercise, Asanas, Pranayama, Meditation, and Relaxation. These exercises will be introduced gradually, and adolescent girls will be performing the intervention for a duration of 45 minutes under the supervision of the investigator every day for 12 weeks. The students will do the yoga training under the supervision of the research team. After 12 weeks of intervention, the data will be collected by using the same tools as that of the pretest.  After the posttest assessment, the meditation and yoga intervention will be taught for the control group as well.

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Detailed Description

Not available

Recruitment & Eligibility

Status
Not Yet Recruiting
Sex
Female
Target Recruitment
400
Inclusion Criteria
  • Based on simple random sampling, adolescent girls who are in the age group of 12-18 years of Udupi district are selected in phase 1.
  • In phase 2 adolescent girls selected from phase 1 with a numerical pain rating scale score of more than 4 are subjected to Yoga and Meditation.
Exclusion Criteria

Adolescent girls who are not willing to participate are excluded.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
PainBaseline (pretest assessment) | Post-test after 12 weeks of intervention
Secondary Outcome Measures
NameTimeMethod
Stress, Academic performance(Concentration and Absenteeism),Perceived Self-efficacy and Bio-markers(Hb,Progesterone,Estrogen,Prostaglandins)Baseline (pretest assessment)

Trial Locations

Locations (9)

Amratha Bharathi Vidhyalaya HPS

🇮🇳

Udupi, KARNATAKA, India

Amratha Bharathi Vidyakendra

🇮🇳

Udupi, KARNATAKA, India

Dr Shankara Adyanthaya Memorial EMHS

🇮🇳

Udupi, KARNATAKA, India

Govt High School

🇮🇳

Udupi, KARNATAKA, India

Jaycees English Medium School

🇮🇳

Udupi, KARNATAKA, India

Navodaya Vidyalaya

🇮🇳

Udupi, KARNATAKA, India

Shri Venkataramana English Medium higher primary school

🇮🇳

Udupi, KARNATAKA, India

Sri Bhuvanendra Residential School

🇮🇳

Udupi, KARNATAKA, India

St Lawrence High School Atturu

🇮🇳

Udupi, KARNATAKA, India

Amratha Bharathi Vidhyalaya HPS
🇮🇳Udupi, KARNATAKA, India
Aparna Achar
Principal investigator
7259003860
abvschool@gmail.com

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