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A clinical trial to study the effect of an Integrated Risk Reduction Program (IRRP) among nursing students with risk for Polycystic Ovary Syndrome (PCOS)in Udupi and Dakshina Kannada Districts of Karnataka.

Effectiveness of an Integrated Risk Reduction Program (IRRP) on quality of life, self-esteem, academic stress, diet quality, and lifestyle practices among nursing students with risk for Polycystic Ovary Syndrome (PCOS) in Udupi and Dakshina Kannada Districts of Karnataka: A Cluster Randomized Controlled Trial - NIL

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/03/081974
Enrollment
4689
Registered
2025-03-07
Start date
Unknown
Completion date
Unknown
Last updated
2026-09-14

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

Conditions

None listed

Interventions

Intervention1: Integrated Risk Reduction Program (IRRP): This study aims to assess the risk of PCOS among nursing students in Udupi and Dakshina Kannada Districts (Phase I) and implement an Integrated

Sponsors

Manipal College of Nursing
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Phase I: Nursing students who are; female. age 18-25 years. present at the time of data collection. willing to participate in the study. pursuing full-time B.Sc nursing courses. studying in I, II, III, and IV year of BSc nursing. Phase II: Nursing students who will be; at risk for PCOS as per the scores obtained in the Self-Administered PCOS Risk Assessment Questionnaire.

Exclusion criteria

Exclusion criteria: Phase I: Nursing students who are; married. sick at the time of data collection. having comorbidities during the time of data collection. Phase II: Nursing students who are; married. studying in final year. not willing to provide Informed Consent (IC). diagnosed as having PCOD/ PCOS in between the intervention and post-test periods in the intervention arm. using any of the stress relieving techniques or therapies.

Design outcomes

Primary

MeasureTime frame
Risk for PCOS, quality of life, self-esteem, academic stress, diet quality, lifestyle practices.Timepoint: The 3rd month post-test will be done for Academic Stress, and Diet Quality. Assessing the risk for PCOS, Quality of Life, Self-Esteem, Academic Stress, Diet Quality,and Lifestyle Practices will be done after the 6th month of intervention.—

Secondary

MeasureTime frame
PCOS related variables, and Knowledge on PCOS.Timepoint: The post-test will be done in intervention arm in the day after intervention (Day 5) for knowledge on PCOS. The 3rd and 6th month post-test will be done for the PCOS related variables, and knowledge on PCOS.—

Countries

India

Contacts

Public ContactDr E Binu Margaret

Manipal College of Nursing, Manipal Academy of Higher Education, Manipal.

anice.george@manipal.edu9632094766

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Sep 19, 2026