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CTRI Number  CTRI/2021/11/037703 [Registered on: 01/11/2021] Trial Registered Prospectively
Last Modified On: 25/10/2021
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Yoga & Naturopathy 
Study Design  Cluster Randomized Trial 
Public Title of Study   Effectiveness of Meditation and Yoga on painful Menstruation among adolescent girls 
Scientific Title of Study   Meditation and Yoga impact on Dysmenorrhea (MY ID Study) 
Trial Acronym  MY ID  
Secondary IDs if Any  
Secondary ID  Identifier 
NA  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Anice George 
Designation  Professor and Former Dean  
Affiliation  Manipal College of Nursing, MAHE 
Address  Professor and Former Dean, Department of Child Health Nursing, Room No: 604 Manipal College of Nursing Manipal,Manipal Academy of Higher Education, Madhavnagar, Manipal,Udupi

Udupi
KARNATAKA
576104
India 
Phone  9632094766  
Fax    
Email  anice.george@manipal.edu  
 
Details of Contact Person
Scientific Query
 
Name  Mrs Shalini G Nayak 
Designation  Assistant Professor 
Affiliation  Manipal College of Nursing, MAHE 
Address  Assistant Professor Department of Medical Surgical Nursing Room no: 404 Manipal College of Nursing Manipal,Manipal Academy of Higher Education, Madhavnagar, Manipal,Udupi

Udupi
KARNATAKA
576104
India 
Phone  9481375675  
Fax    
Email  shalini.mcon@manipal.edu  
 
Details of Contact Person
Public Query
 
Name  Anil Raj 
Designation  PhD Scholar & Former faculty 
Affiliation  Manipal College of Nursing, MAHE 
Address  PhD Scholar & Former faculty Department of Medical Surgical Nursing Room No: 404 Manipal College of Nursing Manipal Academy of Higher Education Manipal
Manipal College of Nursing Manipal Academy of Higher Education Manipal
Udupi
KARNATAKA
576104
India 
Phone  07411892986  
Fax    
Email  anilrajan1987@gmail.com  
 
Source of Monetary or Material Support  
DST:SATYAM (Department of Science and Technology) 
 
Primary Sponsor  
Name  DSTSATYAM 
Address  Technology Bhavan New Mehrauli Road New Delhi-110016 
Type of Sponsor  Government funding agency 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NA 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 9  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Aparna Achar  Amratha Bharathi Vidhyalaya HPS   Hebri, Karkala taluk Pin-576112
Udupi
KARNATAKA 
7259003860
1
abvschool@gmail.com 
Arun H Y  Amratha Bharathi Vidyakendra  Mithilanagara, Hebri, Karkala taluk Pin-576112
Udupi
KARNATAKA 
7259003865
1
abvkhebri@gmail.com 
Radha Prabhu  Dr Shankara Adyanthaya Memorial EMHS  Nitte post, Kemmannu road,Karkala Pin-576110
Udupi
KARNATAKA 
9972030019
1
drnsampuc_nitte@yahoo.com 
Indira  Govt High School   Kabettu, Karkala taluk, Pin-574104
Udupi
KARNATAKA 
9449470374
1
ghskabettu@gmail.com 
Sudharani  Jaycees English Medium School  Swarajya Maidhan, Karkala Pin-574104
Udupi
KARNATAKA 
9483824740
1
jayceesschool@gmail.com 
T Palanivelu  Navodaya Vidyalaya  Chara, Hebri, Karkala taluk Pin-576112
Udupi
KARNATAKA 
7022535020
1
jnvudupi@gmail.com 
Mohini  Shri Venkataramana English Medium higher primary school  Karkala Pin-574104
Udupi
KARNATAKA 
9591272072
1
svtems@gmail.com 
Ragavendra  Sri Bhuvanendra Residential School  Madhav Nagar, Karkala Pin-574104
Udupi
KARNATAKA 
8197421795
1
sbrs2002@gmail.com 
Sr Precilla  St Lawrence High School Atturu  Atturu church road, Karkala taluk Pin- 574117
Udupi
KARNATAKA 
8762977213
1
stlawrencehsattur@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 9  
Name of Committee  Approval Status 
Amratha Bharathi Vidhyakendra  Approved 
Amratha Bharathi Vidyalaya HPS  Approved 
Dr Shankara Adyanthaya Memorail EMHS  Approved 
Govt High School Kabettu  Approved 
Jaycees English Medium School  Approved 
KMC& KH IEC  Approved 
Navodaya Vidyalaya  Approved 
Shri Venkataramana English Medium higher primary school  Approved 
Sri Buvanendra Residential School  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Adolescent girls those who are experiencing dysmenorrhea (2022 ICD-10-CM Diagnosis Code N94.6)  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Meditation and Yoga  Adolescent girls under control group will be subjected for Yoga and Meditation only after the posttest assesment. 
Intervention  Meditation and Yoga  Adolesecnt girls with the pain intensity more than 4 will be subjected to Yoga and Meditation.Intervention will be carried out for 5 days a week for a period of 12 weeks. Time taken for intervention will be 45 minutes. Intervention will not be performed for initial 3 days of menstruation. 
 
Inclusion Criteria  
Age From  12.00 Year(s)
Age To  18.00 Year(s)
Gender  Female 
Details  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. 
 
ExclusionCriteria 
Details  Adolescent girls who are not willing to participate are excluded. 
 
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 
Pain  Baseline (pretest assessment)
Post-test after 12 weeks of intervention  
 
Secondary Outcome  
Outcome  TimePoints 
Stress, Academic performance(Concentration and Absenteeism),Perceived Self-efficacy and Bio-markers(Hb,Progesterone,Estrogen,Prostaglandins)  Baseline (pretest assessment)
Post-test after 12 weeks of intervention  
 
Target Sample Size   Total Sample Size="400"
Sample Size from India="400" 
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)   09/11/2021 
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="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
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. Yoga and 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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