跳至主要内容
临床试验/CTRI/2025/11/096890
CTRI/2025/11/096890招募中不适用

Musculoskeletal pain, Fatigue and sleep quality among college students with and without polycystic ovarian syndrome(PCOS) : A case control study

Christy sopna S1 个研究点 分布在 1 个国家目标入组 174 人开始时间: 2025年11月17日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
174
试验地点
1
主要终点
• Modified Nordic musculoskeletal questionnaire – To measure the musculoskeletal pain

研究概览

简要总结

1. INTRODUCTION:

Polycystic Ovarian Syndrome (PCOS) is a prevalent endocrine disorder affecting 6–10% of women of reproductive age globally, with even higher prevalence in South Asian countries like India  While PCOS is widely studied for its metabolic and reproductive implications, its impact on musculoskeletal health, fatigue, and sleep quality is underexplored.

Emerging evidence suggests that PCOS is associated with chronic low-grade inflammation, insulin resistance, and obesity - factors contributing to musculoskeletal pain and fatigue

This study aims to compare the prevalence and severity of musculoskeletal pain, fatigue, and sleep quality in college-aged females with and without PCOS

Primary objectives:

·       To compare the prevalence of musculoskeletal pain, fatigue, and quality of sleep among college girls with PCOS and without PCOS

Secondary objectives

·       To analyse the association between musculoskeletal pain and fatigue between the girls with PCOS and the control group without PCOS

·       To analyse the association between musculoskeletal pain and quality of sleep between the girls with PCOS and control group without PCOS

·       To analyse the association between fatigue and quality of sleep between the girls with PCOS and control group without PCOS

·       To assess the correlation between musculoskeletal pain , fatigue and sleep quality among girls with PCOS and without PCOS

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 25.00 Year(s)(—)
性别
Female

入选标准

  • College girls aged between 18-25
  • BMI 18-35 Kg/m2
  • Unmarried girls
  • Diagnosed cases of PCOS based on Rotterdam criteria
  • College girls who are willing to participate
  • Subjects who are willing to provide informed consent.
  • Sufficient English/tamil language to understand and complete the outcome tool.

排除标准

  • Other causes of menstrual disturbances, hyperandrogenism, adrenal diseases and pregnancy
  • Known cardiovascular problems, uncontrolled hypertension or hypotension
  • Presence of neurological disease, orthopaedic illness, cardiopulmonary disease and musculoskeletal injuries
  • Known psychiatric illness, Physical ailments & musculoskeletal injuries
  • Inability to cooperate
  • Any other hormonal imbalances
  • Married girls with PCOS
  • concurrent treatments (insulin sensitizers as metformin and pioglitazone)
  • adrenal hyperplasia, thyroid dysfunction, hyperprolactinaemia, chronic cough (bronchitis) during the last three months, gastrointestinal disease, asthma, diabetes, urinary tract infection
  • College girls taking any anti-allergic or pain medications.

结局指标

主要结局

• Modified Nordic musculoskeletal questionnaire – To measure the musculoskeletal pain

时间窗: baseline

• Fatigue severity scale (FSS) – To measure fatigue level

时间窗: baseline

• Pittsburg sleep quality Index (PSQI) – To measure the quality of sleep

时间窗: baseline

次要结局

未报告次要终点

研究者

发起方
Christy sopna S
申办方类型
Other [self financed ]
责任方
Principal Investigator
主要研究者

Christy sopna s

college of allied health sciences East coast institute of medical sciences

研究点 (1)

Loading locations...

相似试验