NCT07499245

Brief Summary

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
6mo left

Started Mar 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress30%
Mar 2026Dec 2026

Study Start

First participant enrolled

March 1, 2026

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

March 4, 2026

Completed
26 days until next milestone

First Posted

Study publicly available on registry

March 30, 2026

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

March 30, 2026

Status Verified

March 1, 2026

Enrollment Period

9 months

First QC Date

March 4, 2026

Last Update Submit

March 23, 2026

Conditions

Keywords

older adultsvirtual realitysleep qualitycomfortcare

Outcome Measures

Primary Outcomes (1)

  • Sleep quality

    Richards-Campbell Sleep Questionnaire: Developed by Richards in 1987, the Richards-Campbell Sleep Questionnaire (RCSQ) is a six-item scale that assesses the depth of nighttime sleep, time to fall asleep, frequency of awakenings, duration of wakefulness, quality of sleep, and ambient noise level. Each item is evaluated on a visual analog scale ranging from 0 to 100. A score of 0-25 indicates very poor sleep, while a score of 76-100 indicates very good sleep. Higher scores indicate improved sleep quality. The Cronbach's α value for the scale developed by Richards is 0.82.

    1st midterm test: second day, 2nd midterm test: third day, final test: fourth day

Secondary Outcomes (1)

  • Comfort

    8 month (A final test will be performed after 4 days of treatment for each patient, a total of 240 days for 60 patients)

Study Arms (2)

Virtual reality

EXPERIMENTAL

Older adults with insomnia in the experimental group will undergo a 20-minute virtual reality session. The study group, consisting of elderly adults meeting the inclusion criteria, will be given an Elderly Adult Identifier Form, after which the VR SHINECON GO4EA virtual reality headset will be applied by the researcher for 20 minutes at bedtime (routinely at 10:30 PM) for three nights. Before the first night's virtual reality headset application, sleep quality and comfort levels will be assessed. These assessments will be repeated in the morning after the virtual reality headset application.

Device: using virtual reality

Control group

NO INTERVENTION

Older adults in the control group will not receive any intervention aimed at improving sleep quality and comfort. During the study period, no interventions aimed at improving sleep quality and comfort will be performed on the older adults in this group. Routine clinical care will be applied. After administering the Older Adult Identifier Form, the older adults will have their sleep quality and comfort assessed on the first night. Their sleep quality and comfort will be assessed again after they wake up in the morning.

Interventions

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 with a starry night sky and one with night rain sound - will be selected according to the elderly adults' preference. After each participant's use, the headphone jack of the virtual reality glasses will be wiped with an antiseptic solution. The "Richards-Campbell Sleep Scale (RCSQ)" and the "VAS Comfort Scale (VCS)" will be used to collect data.

Virtual reality

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kafkas University, Faculty of Health Sciences Department of Nursing

Kars, 36100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: This is a prospective, randomized controlled experimental study.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Kafkas University, Faculty of Health Sciences, Department of Nursing

Study Record Dates

First Submitted

March 4, 2026

First Posted

March 30, 2026

Study Start

March 1, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

March 30, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations