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Набор скоро начнётся NCT07261124

Effect of Health Promotion Model-Based Oculomotor Exercise Program on Sleep Quality in Older Adults

Без фазы С лечением Sleep Quality Older Adults (65 Years and Older)

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Oculomotor Exercise Program.
Кому может быть актуально
Состояния в реестре: Sleep Quality, Older Adults (65 Years and Older). Базовые параметры: от 65 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Turkey (Türkiye)
Следующий шаг
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Официальное название

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

Обзор

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?

Подробное описание

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.

Вмешательства

  • Поведенческое Oculomotor Exercise Program
    This intervention is a structured oculomotor exercise program based on the Health Promotion Model, developed to improve sleep quality among older adults living in a nursing home. The program focuses on enhancing visual-motor coordination and relaxation through systematic eye movement exercises. Participants in the experimental group perform oculomotor exercises three times per week for four consecutive weeks under researcher supervision. The program includes educational support and brief motiva

Первичные конечные точки

  • Sleep Quality [Срок оценки: Baseline, 4 weeks, 2 and 3 months after the intervention]
Вторичные конечные точки (1)
  • Stage of Behavioral Change [Срок оценки: Baseline, 4 weeks, 2 and 3 months after the intervention]

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Поддерживающая терапия

Центры проведения

Turkey (Türkiye) · 1 центр
  • A Nursing home facility in Istanbul — Istanbul

Идентификаторы

NCT: NCT07261124 · IUC_LEE_HS_1

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗