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Набор по приглашению NCT07499245

The Effect of Virtual Reality in Older Adults

Без фазы С лечением Older Adults (65 Years and Older) Older Adults Without Any Specific Clinical Condition

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: using virtual reality.
Кому может быть актуально
Состояния в реестре: Older Adults (65 Years and Older), Older Adults Without Any Specific Clinical Condition. Базовые параметры: от 60 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
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

The Effect of Virtual Reality on Sleep Quality and Comfort in Older Adults

Обзор

This research will be conducted to examine the effects of virtual reality on sleep quality and comfort in older adults. This research will be conducted as a single-blind, randomized controlled experimental study with a pre-test-post-test design, involving application and control groups, to examine the effect of virtual reality on sleep quality and comfort in elderly adult patients hospitalized in the internal medicine and surgical clinics of Kars Harakani State Hospital between December 15, 2025, and December 31, 2026. To inform older adults, and after obtaining informed consent, the study will be administered using a "Senior Adult Descriptive Information Form" containing demographic information about older adults, the Standardized Mini Mental Test which assesses the cognitive level of older adults, and a "Senior Adult Monitoring Form" to track any potential side effects of the intervention. The Senior Adult Descriptive Information Form, the Richards-Campbell Sleep Scale (RCSQ), and the VAS Comfort Scale (VCS) will be used to collect data for the study. Data will be collected from elderly adults hospitalized in the internal medicine and surgical clinics of Kars Harakani State Hospital who meet the research criteria. They will be shown 360-degree video images (Chitra and Eremita 2023; Eremita and Chitra 2024) for 20 minutes each night during their hospitalization hours using VR Shinecon virtual reality glasses.

Подробное описание

This research will be conducted to examine the effect of virtual reality on sleep quality and comfort in older adults hospitalized in internal medicine and surgical clinics. New technologies such as virtual reality are gaining interest as a non-pharmacological intervention in various clinical settings(Lee et al. 2019; D'Cunha et al. 2019; Kim et al. 2024; Szczepocka et al. 2024; Szczepocka, Mokros et al. 2024). Virtual reality offers a unique opportunity to expose individuals to various simulated natural and social environments that can be both calming and engaging(Appel et al. 2020; Appel et al. 2021; Chitra and Eremita 2023; Eremita and Chitra 2024). Virtual reality provides visual and auditory stimuly.(Appel et al. 2020; Hung et al. 2025; Liu et al. 2025). In their study, Lee and Kang(2020) stated that virtual reality could be beneficial as a nursing intervention method for providing a positive cognitive stimulus and blocking environmental stimuly. Although virtual reality is generally sometimes seen as a technology geared towards young people, research has shown that it is easily adopted by many older individuals and has the potential to improve participation and well-being in older adults.(Lee at al. 2019; Syed-Abdul et al. 2019; D'Cunha et al. 2019; Dermody et al. 2020; Cheng et al. 2020; Kalantari et al. 2023; Cinalioglu et al. 2023; Hung et al. 2025). Sleep is a fundamental physiological process for life(Yan et al. 2022; Kim et al. 2024). Sleep disorders are a common problem during the aging process(Sun et al. 2016; Çınar Yücel et al. 2016; Tseng et al. 2020; Martini et al. 2024) and can significantly affect comfort(Martini et al. 2024). With the progression of age, falling asleep becomes difficult, sleep is interrupted by frequent awakenings, the depth of sleep decreases, and the time spent sleeping in bed increases, and as a result, sleep gradually moves away from being satisfying(Çınar Yücel et al. 2016). Insufficient sleep can lead to problems such as memory loss, lack of concentration, as well as heart disease, hypertension, arrhythmia, stroke and impairment of the immune system(Huang et al. 2022; Wan et al. 2024; Sharma and Dhaka 2025), may also lead to fatigue and excessive daytime sleepiness(Tseng et al. 2020; Chitra and Eremita 2023; Eremita and Chitra 2024).The use of virtual reality may also positively affect sleep quality(Lee and Kang 2020; Eremita and Chitra 2024; Martini et al. 2024; Liu et al. 2025; Sharma and Dhaka 2025). Virtual reality helps alleviate difficulties in falling asleep by targeting pre-sleep arousal(Zambotti et al. 2020; Sharma and Dhaka 2025). Virtual reality 360-degree video nature images can release Gamma-aminobutyric acid, which is necessary to support sleep(Chitra and Eremita 2023; Eremita and Chitra 2024) and increase relaxation(Zambotti et al. 2020; Cinalioglu et al. 2023; Martini et al. 2024; Wan et al. 2024; Sharma and Dhaka 2025). It was found that a 30-minute virtual reality meditation session on the evening of hospital admission positively affected the sleep quality of intensive care unit patients(Lee and Kang 2020). Chitra and Eremita(2023) and Kim et al.(2024)'s studies indicate that virtual reality can be used to improve the sleep quality of students experiencing sleep problems. In a study conducted to investigate the effectiveness of virtual reality therapy administered at home once daily in the evening for 6 weeks in chronic imsomnia patients, it was reported that virtual reality therapy improved sleep quality(Wan et al. 2024). Virtual reality is increasingly being used in elderly care settings, including long-term care(Lee at al. 2019; Hung et al. 2025). Older patients require regular sleep to live their lives in the best possible way and maintain their bodily functions(Çınar Yücel et al. 2016). Information regarding virtual reality for older adults is limited, and the research literature is still quite insufficient(Zambotti et al. 2020; Kalantari et al. 2023; Martini et al. 2024; Szczepocka, Mokros et al.2024; Sharma and Dhaka 2025). When examining the national and international literature; Virtual Reality Guided Imagery has been found to improve sleep quality among older adults(Martini et al. 2024; Sharma and Dhaka 2025-meta analysis study), Virtual Reality Exercise Games(Peng et al. 2024-meta analysis study ) and virtual reality combined with aromatherapy to improve comfort (Hung et al. 2025) it has been seen that there are studies in which it is used. It is believed that the virtual reality goggle application will enable elderly adults to relax their minds and bodies by blocking external stimuly, provide an innovative, effective, safe, and comfortable nursing care method that can be implemented without a doctor's prescription for the management of elderly adults' sleep problems, and contribute to the literature.

Вмешательства

  • Устройство using virtual reality
    Older adults with insomnia in the experimental group will undergo a 20-minute virtual reality session. Data will be collected from elderly adults hospitalized in the internal medicine and surgical clinics of Kars Harakani State Hospital who meet the research criteria. They will be shown 360-degree video images (Chitra and Eremita 2023; Eremita and Chitra 2024) for 20 minutes each night during their hospitalization hours using VR Shinecon virtual reality glasses. One of two 1-hour videos - one wi

Первичные конечные точки

  • Sleep quality [Срок оценки: 1st midterm test: second day, 2nd midterm test: third day, final test: fourth day]
Вторичные конечные точки (1)
  • Comfort [Срок оценки: 8 month (A final test will be performed after 4 days of treatment for each patient, a total of 240 days for 60 patients)]

Критерии участия

Критерии включения

  • Older adults willing to participate in the study
  • Being 60 years of age or older
  • Not having been diagnosed with Parkinson's disease or a psychiatric disorder, not having cognitive impairment, and being able to communicate
  • Absence of a sleep apnea diagnosis
  • Scoring 24 or higher on the Standardized Mini Mental Test
  • The participant stated that her average nightly sleep duration is less than 5 hours
  • Avoid using medications that may affect sleep (acetylcholinesterase inhibitors, beta-blockers, diuretics, phenytoin, theophylline, benzodiazepines, etc.)
  • Hospital stay must be at least 3 days
  • Avoid smoking in the last 15 minutes before a session and avoid using caffeine stimulants (tea/coffee/chocolate/cola etc.) exceeding 1.4 mg/kg in the 10 hours prior.
  • Lack of photosensitivity
  • Eye disease and absence of contact lenses

Критерии исключения

  • Those unwilling to participate in the study
  • Those who are not 60 years of age or older
  • Patients diagnosed with Parkinson's disease and psychiatric disorders, who have cognitive impairment and are unable to communicate
  • Having a diagnosis of sleep apnea
  • Those who score below 24 on the Standardized Mini Mental Test
  • Those who stated that their average nightly sleep duration is more than 5 hours
  • Those who use medication (acetylcholinesterase inhibitor, beta blocker, diuretic, phenytoin, theophylline, benzodiazepine etc.) that can affect sleep
  • Hospital stay of 3 days or less
  • Smoking a cigarette in the last 15 minutes before a session and using caffeine stimulants (tea/coffee/chocolate/cola etc.) above 1.4 mg/kg 10 hours prior
  • Having photosensitivity
  • Older adults with eye disease and contact lenses

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
Тройное слепое
Основная цель
Поддерживающая терапия

Центры проведения

Turkey (Türkiye) · 1 центр
  • Kafkas University, Faculty of Health Sciences Department of Nursing — Kars

Идентификаторы

NCT: NCT07499245 · 81829502.903/109

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗