| CTRI Number |
CTRI/2025/07/091916 [Registered on: 28/07/2025] Trial Registered Prospectively |
| Last Modified On: |
01/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Mind-Body Module Towards Resilience Building and wellness Promotion] |
| Study Design |
Other |
|
Public Title of Study
|
How Common Menstrual Problems Are Among Bharatanatyam Dancers and How These Issues Affect Their Dance Performance |
|
Scientific Title of Study
|
Prevalence Of Menstrual Dysfunction Among Bharatanatyam Dancers And Its Role In Their Performance Parameters |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Swarnamalya M |
| Designation |
PhD Scholar |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
Department of Mind Body Medicine & Lifestyle Sciences, Faculty of Behavioral and Social sciences. No.1 Ramachandra Nagar Porur, Chennai - 600 116 Tamil Nadu, India.
Chennai
TAMIL NADU
600116
India |
| Phone |
9841891418 |
| Fax |
|
| Email |
u022401027@sriramachandra.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr DC Mathangi |
| Designation |
Professor and Head of The Department of Mind Body Medicine & Lifestyle Sciences |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
Department of Mind Body Medicine & Lifestyle Sciences, Faculty of Behavioral and Social sciences. No.1 Ramachandra Nagar Porur, Chennai - 600 116 Tamil Nadu, India.
Chennai
TAMIL NADU
600116
India |
| Phone |
9940635874 |
| Fax |
|
| Email |
dcmathangi@sriramachandra.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr DC Mathangi |
| Designation |
Professor and Head of The Department of Mind Body Medicine & Lifestyle Sciences |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
Department of Mind Body Medicine & Lifestyle Sciences, Faculty of Behavioral and Social sciences. No.1 Ramachandra Nagar Porur, Chennai - 600 116 Tamil Nadu, India.
Chennai
TAMIL NADU
600116
India |
| Phone |
9940635874 |
| Fax |
|
| Email |
dcmathangi@sriramachandra.edu.in |
|
|
Source of Monetary or Material Support
|
| SRI RAMACHANDRA INSTITUTE OF HIGHER EDUCATION AND RESEARCH, Ramachandra Nagar, Porur, Chennai, Tamil Nadu, India, Chennai-600 116 |
|
|
Primary Sponsor
|
| Name |
Swarnamalya M |
| Address |
No.1, Ramachandra Nagar, Porur, Chennai-600 116, Tamil Nadu, India |
| Type of Sponsor |
Other [Institutional Fellowship] |
|
|
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 |
| Ms Swarnamalya M |
Dance schools, Music and fine arts colleges, Dance institutions |
Dance schools, Music and fine arts colleges, Dance institutions in and around Chennai
Chennai
TAMIL NADU |
9841891418
u022401027@sriramachandra.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri Ramachandra Institute of Higher Education and Research, Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Nil |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Mind-Body Module Towards Resilience Building and Wellness Promotion |
A structured 8-week mind-body module aimed at enhancing psychological, physiological, and physical well-being among female Bharatanatyam dancers with menstrual dysfunction. The intervention integrates breathing exercises, yoga postures, mindfulness practices, guided imagery, and cognitive-behavioral techniques. Sessions will be delivered in a hybrid mode—partly in person and partly through virtual platforms. Participant adherence will be supported through regular follow-up using logbooks, mobile messaging applications such as WhatsApp, and social media-based check-ins. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
1. Female Bharatanatyam dancers aged between 18 to 35 years
2. Minimum of 5 years of regular Bharatanatyam practice
3. No major injuries in the past 2 months |
|
| ExclusionCriteria |
| Details |
1. Dancers with current or chronic injuries
2. Pregnant or lactating mothers
3. On any medication for psychological, sleep disturbances, cardio-respiratory problems, and Oral contraceptives
4. Classical dancers other than Bharatanatyam |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Prevalence of menstrual dysfunction among female Bharatanatyam dancers and its impact on physical (flexibility, balance), physiological (VO2 max, body composition, energy availability, sleep status), and psychological (mood, stress, quality of life, self-efficacy) parameters. |
All primary outcomes will be assessed at Baseline (Day 0) through one-time cross-sectional and comparative assessments at the time of recruitment.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Change in physical well-being parameters (flexibility, balance) after the 8-week mind-body intervention
2. Change in physiological parameters (VO2 max, body composition, energy availability, sleep status) following the intervention
3. Change in psychological well-being parameters (mood, stress, quality of life, self-efficacy) following the intervention
These outcomes apply to the intervention subgroup (n = 10) undergoing the 8-week mind-body module. |
Day 0 (pre-intervention) & Week 8 (post-intervention) |
|
|
Target Sample Size
|
Total Sample Size="350"
Sample Size from India="350"
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)
|
08/08/2025 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
This study aims to assess the prevalence and impact of menstrual dysfunction on physical, physiological, and psychological parameters among female Bharatanatyam dancers aged 18 to 35 years. A total of 350 participants will be recruited to determine the prevalence of menstrual dysfunction using validated questionnaires. From this group, 246 dancers will be categorized based on menstrual regularity for comparative analysis of flexibility, balance, VO2 max, body composition, energy availability, sleep quality, mood, stress, quality of life, and self-efficacy.
From which 10 participants with menstrual dysfunction will undergo an 8 week mind body intervention. Pre and post assessments will be conducted to evaluate its effectiveness. The study follows a cross sectional and comparative design, using physical assessments, self reported questionnaires, and physiological tests. The findings are expected to provide insights into the health and performance needs of classical dancers and support wellness-based strategies. |