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Integrated Yoga intervention for Primary Dysmenorrhea: A RCT on Biochemical, Hormonal, and Psychosocial Outcomes with Development, Validation, and Feasibility Testing

Efficacy of an Integrated Yoga Intervention on Biochemical Markers, Hormonal Profiles, Pain, and Psychosocial Well-Being in Women with Primary Dysmenorrhea: Development, Validation, Feasibility Testing - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/04/085849
Enrollment
60
Registered
2025-04-28
Start date
Unknown
Completion date
Unknown
Last updated
2025-05-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: N944- Primary dysmenorrhea

Interventions

Intervention1: Validated integrated yoga intervention: Experimental group will receive 60 min structured yoga sessions of validated yoga protocol by certified yoga therapist, 3 times in a week for 8 w

Sponsors

Dr Sanjib Kumar Patra
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: The study will include women aged 18-26 with regular menstrual cycles (21-35 days) and a clinical diagnosis of primary dysmenorrhea. Participants must experience moderate to severe menstrual pain along with symptoms like headaches, nausea, and vomiting, with pain onset 6-12 hours after menstruation begins and lasting 8-72 hours. They must experience at least 4 consecutive painful periods in the past six months. Participants must be healthy with no major chronic illnesses and no regular yoga practice in the last six months, and they must provide written informed consent.

Exclusion criteria

Exclusion criteria: women with secondary dysmenorrhea or significant gastrointestinal, gynaecological or autoimmune disease or gynaecological surgery, or, those using hormonal contraceptives or medications that could affect the menstrual cycle or pain perception.

Design outcomes

Primary

MeasureTime frame
Protaglandins Progestrone TNF alpha Interluekin(IL6 and IL 1 beta) and Pain intensityTimepoint: At Baseline and after 8 week of intervention

Secondary

MeasureTime frame
1 Pain outcomes including primary dysmenorrhea severity will assess through WaLIDD Scale,and associated symptoms through Cox Menstrual Symptom Scale (CMSS) 2.Autonomic measures such as Short-term HRV via Biopac MP36. 3. Cognitive functions via PEBEL software includes variables such as Selective attention, Sustained attention, Working memory and Executive function. 4. Psychosocial measures includes Menstrual Distress Questionnaire (MEDI-Q), Depression, Anxiety and Stress Scale (DASS-21), Pain Catastrophizing Scale (PCS), Health-Related Productivity Questionnaire (HRPQ), Quality of Life Enjoyment and Satisfaction Questionnaire-short form (Q-LES-Q-SF), Functional and Emotional Measure of Dysmenorrhea (FEMD), Sleep Quality (Pittsburgh Sleep quality index) and World Health Organization Quality of life scale (WHOQOL-BREF) Timepoint: At Baseline and after 8 week of intervention

Countries

India

Contacts

Public ContactDr Sanjib K Patra

Central University of Rajasthan

sanjib.patra@curaj.ac.in8618142265

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026