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临床试验/NCT06646549
NCT06646549已完成不适用

The Association of Insomnia With Fatigue and Mood in Postmenopausal Osteoporosis

Beylikduzu State Hospital1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2024年5月19日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
200
试验地点
1
主要终点
Insomnia Severity Index

研究概览

简要总结

Aim of the study was to determine the presence of sleep problems in postmenopausal osteoporosis patients and to examine the relationship between the severity of insomnia and mood and fatigue. Pain, sleep problems, depression, anxiety, and fatigue were assessed using appropriate scales

详细描述

The research was planned as a clinical cross-sectional study. Two hundred women, aged between 50-75 years, who were diagnosed with postmenopausal osteoporosis and followed up in the outpatient clinics of Beylikdüzü State Hospital and Istanbul Physical Medicine and Rehabilitation Training and Research Hospital between May 19, 2024, and June 19, 2024, were included. Sociodemographic data such as gender, height, weight, body mass index, educational status, and occupation were recorded. The date of osteoporosis diagnosis, history of falls within the last 6 months, presence of fractures due to low-energy trauma, osteoporosis treatment, medications used, and comorbidities were questioned. The presence and location of pain were asked, and if pain was present, its intensity was determined using the Visual Analog Scale. Calcium and vitamin D levels from the last 3 months were recorded. The patient's sleep problems were assessed using the Insomnia Severity Index. Subsequently, the patient's current depression and anxiety-related symptoms were measured using the Hospital Anxiety and Depression Scale (HADS), and the fatigue level was assessed with the Fatigue Severity Scale (FSS).

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Cross Sectional

入排标准

年龄范围
50 Years 至 75 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Women diagnosed with postmenopausal osteoporosis.
  • Patients who agreed to participate in the study.
  • Age range between 50-75 years.

排除标准

  • Presence of fibromyalgia.
  • Chronic fatigue syndrome.
  • Chronic decompensated cardiac, renal, or hepatic failure.
  • Known psychiatric disorders.
  • Rheumatological diseases.
  • Presence of other known neurological diseases.
  • Use of medications that enhance physical performance or alleviate fatigue.

结局指标

主要结局

Insomnia Severity Index

时间窗: 0 day

The Insomnia Severity Index (ISI) is a widely used, validated tool designed to assess the nature, severity, and impact of insomnia. It is a brief, self-report questionnaire consisting of seven items that evaluate various aspects of insomnia, including difficulties falling asleep, staying asleep, waking up too early, satisfaction with sleep, interference with daily functioning, noticeable impairments, and distress caused by sleep problems.The score ranges from 0 to 28. As the score increases, the severity of insomnia worsens.

次要结局

  • Fatigue Severity Scale(0 day)
  • Hospital Anxiety and Depression Scale(0 day)

研究者

发起方
Beylikduzu State Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Busra Sirin

Principle Investigator

Beylikduzu State Hospital

研究点 (1)

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