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临床试验/NCT07261124
NCT07261124尚未招募不适用

Investigation of the Effect of Health Promotion Model Based Oculomotor Exercise Program on Sleep Quality in Elderly Living in a Nursing Home: A Randomized Controlled Trial

Istanbul University - Cerrahpasa1 个研究点 分布在 1 个国家目标入组 68 人开始时间: 2026年1月5日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
68
试验地点
1
主要终点
Sleep Quality

研究概览

简要总结

The goal of this clinical trial is to investigate the effect of a Health Promotion Model-based oculomotor exercise program on sleep quality among older adults living in a nursing home.

The main questions it aims to answer are:

Does the Health Promotion Model-based oculomotor exercise program improve sleep quality in older adults living in a nursing home? Does participation in the program enhance self-efficacy and promote better health behaviors related to sleep?

详细描述

This randomized controlled trial aims to evaluate the effect of a Health Promotion Model-based oculomotor exercise program on sleep quality among older adults living in a nursing home. Participants in the experimental group will receive an approximately 3-month structured intervention integrating oculomotor exercises and motivational interviewing techniques, while the control group will receive no intervention and continue with their usual daily routines.

The intervention is designed according to the components of the Health Promotion Model, targeting self-efficacy and behavior change processes. During the first meeting, participants complete baseline assessments, including the Personal Information Form, Sleep Beliefs Scale, Stages of Change Inventory, DSM-5 Sleep Disorder Scale, and Pittsburgh Sleep Quality Index (PSQI). Over four weeks, participants in the experimental group perform oculomotor exercises three times a week (Monday, Wednesday, Friday) and attend weekly motivational interviewing sessions focusing on awareness, perceived benefits, self-efficacy, decision balance, empowerment, and commitment to behavior. Weekly DSM-5 Sleep Disorder assessments are also conducted.

Follow-up sessions continue during the second and third months to support maintenance of behavior change, with monthly evaluations using the PSQI and Stages of Change Inventory. Sleep diaries are used throughout to monitor participants' sleep patterns. The primary outcome is sleep quality, and secondary outcomes include self-efficacy and behavioral stage of change.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • Aged 65 years or older
  • Residing in the nursing home for at least 6 months
  • Scoring 4 or above on the Mini-Cog test
  • Pittsburgh Sleep Quality Index (PSQI) score ≥ 5 (indicating poor sleep quality)
  • No diagnosis of psychiatric disorders such as depression, bipolar disorder, or schizophrenia
  • No diagnosis of serious sleep disorders such as sleep apnea or narcolepsy
  • No medical condition causing frequent nocturnal awakenings, such as nocturia
  • Not using antipsychotic or other medications that may affect sleep quality
  • Having chronic diseases (e.g., diabetes mellitus, hypertension, coronary artery disease) that are controlled with pharmacological treatment
  • No communication problems

排除标准

  • Older adults unable to perform self-care independently
  • Older adults with dizziness or balance problems
  • Participants who are hospitalized for any reason during the follow-up or exercise sessions will be excluded from the study

结局指标

主要结局

Sleep Quality

时间窗: Baseline, 4 weeks, 2 and 3 months after the intervention

Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI), which evaluates subjective sleep quality, sleep latency, duration, and disturbances over the previous month. Higher scores indicate poorer sleep quality.

次要结局

  • Stage of Behavioral Change(Baseline, 4 weeks, 2 and 3 months after the intervention)

研究者

发起方
Istanbul University - Cerrahpasa
申办方类型
Other
责任方
Principal Investigator
主要研究者

Hande Sabandüzen

PhD Candidate

Istanbul University - Cerrahpasa

研究点 (1)

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