Effect of Lifestyle Intervention on Quality of Life of Women with Polycystic Ovary Syndrome (PCOS)

Phase 3

Not yet recruiting

• Conditions: Obstetrics,

• Registration Number: CTRI/2023/12/060968
• Lead Sponsor: Nirmala Giri

Brief Summary

Polycystic Ovary Syndrome (PCOS) is a prevalent endocrine disorder affecting women of reproductive age. Hormonal imbalances, ovarian dysfunction, and multiple cysts in the ovaries characterize it. The study will take place in carefully selected rural and urban areas of Wardha District. It will employ a quantitative research approach, focusing on a randomized, non-interventional, controlled, single-blind superiority clinical trial design. The participants will be women diagnosed with polycystic ovary syndrome (PCOS). A random sampling by random number table and computer-generated random allocation will be used to select a sample size of 60 participants, with 30 assigned to the interventional group and 30 to the control group. Allocation of the participant will be 1:1.  The study will encompass women with PCOS from both urban and rural areas of Wardha District who have been identified as facing challenges associated with PCOS. The quality of life among these participants will be assessed at baseline using the 26-item PCOSQOL Scale. It is expected that the DESSY program will lead to a significant improvement in the quality of life among women with PCOS. This improvement will likely be observed in various quality-of-life domains, encompassing physical well-being, psychological well-being, social functioning, and overall satisfaction.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2023-09-30
• Study Start: 2024-01-01

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: Female
• Target Recruitment: 46

Inclusion Criteria

• Women aged between 20 and 40 years.
• Women who have been diagnosed with polycystic ovary syndrome (PCOS) within the past 6 months.

Exclusion Criteria

Women with concurrent medical conditions other than PCOS that may significantly impact the study outcomes.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
It is expected that the DESSY program will lead to a significant improvement in the quality of life among women with PCOS. This improvement is likely to be observed in various domains of quality of life, encompassing physical well-being, psychological well-being, social functioning, & overall satisfaction.	It is expected that the DESSY program will lead to a significant improvement in the quality of life among women with PCOS. This improvement is likely to be observed in various domains of quality of life, encompassing physical well-being, psychological well-being, social functioning, & overall satisfaction. Time point of the study is 1 month 3 month and 6 month.

Trial Locations

Locations (1)

Datta Meghe Institute of Higher Education & Research; 🇮🇳 Nagpur, MAHARASHTRA, India

Datta Meghe Institute of Higher Education & Research

🇮🇳Nagpur, MAHARASHTRA, India

Dr Nirmala Giri

Principal investigator

7057899820

nirmalashrinivas66@gmail.com