| 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
|
|
|
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
|
|
|
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. |