Effects of Virtual Reality on Sleep Quality and Mental Well-being
Evaluatıon of the Effect of the Use of Vırtual Realıty Technology on Sleep Qualıty and Mental Well-Beıng in Multıple Sclerosıs Patıents
1 other identifier
interventional
42
1 country
1
Brief Summary
It is known that being in natural environments helps increase a person's well-being. It may not always be easy for individuals with neurological diseases to reach these environments due to their mobility limitations, other symptoms and other diseases. Virtual reality technology offers us unlimited opportunities to create these environments digitally and safely. In this research, virtual nature videos will be watched using virtual reality glasses. This process will be done in the experimental group. In the control group, no action will be taken. The scores of the two groups will be compared. The purpose of this presentation is to investigate whether virtual reality affects the mental well-being of beginners and the limits of sleep.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2024
Shorter than P25 for not_applicable
1 active site
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
First Submitted
Initial submission to the registry
October 2, 2023
CompletedFirst Posted
Study publicly available on registry
October 10, 2023
CompletedStudy Start
First participant enrolled
February 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
November 20, 2024
CompletedJanuary 24, 2025
January 1, 2025
7 months
October 2, 2023
January 21, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Pittsburgh sleep quality index score
The scale evaluates sleep quality over the past 1 month. The first 19 questions are answered by the patient himself, and the last 5 questions are answered by the patient's relative or bed partner, making a total of 24 questions. The first 18 questions answered by the patient himself (self-assessment) are included in the scoring. The remaining 6 questions are used only for clinical information. A score higher than five indicates that sleep quality is significantly inadequate. The scores obtained after 6 weeks of proces will be analyzed. If sufficient power is not achieved as a result of the analysis, the number of samples will be increased.
6 week
Warwick-Edinburgh Mental Well-Being Scale score
The scale covers subjective and psychological well-being states. The scale consists of 14 questions of five-point Likert type. There are no sub-dimensions in the scale. Participants answer the questions as 1: I completely disagree, 2: I disagree, 3: I somewhat agree, 4: I agree and 5: I completely agree. The lowest score from the scale is 14 and the highest score is 70. There are no reverse items in the scale. As the score obtained from the scale increases, the level of mental well-being also increases.The scores obtained after 6 weeks of proces will be analyzed. If sufficient power is not achieved as a result of the analysis, the number of samples will be increased.
6 week
Study Arms (2)
Experimental group
EXPERIMENTALVirtual reality glasses will be applied 2 days a week for 6 weeks. A sleep quality scale and a mental well-being scale will be applied before and after the procedure.
Control group
NO INTERVENTIONThere will be no virtual reality application. Sleep quality and mental well-being scale will be applied every 6 weeks.
Interventions
Patients will be shown nature videos via the specified virtual reality connection.
Eligibility Criteria
You may qualify if:
- Being diagnosed with multiple sclerosis (any type)
- Not being in an MS attack period
- Being between the ages of 18-80
- Having the level of awareness to maintain healthy communication
- Volunteering to participate in the study
You may not qualify if:
- Having impaired cognitive functions at a level that prevents maintaining healthy communication and responding to data collection forms.
- Being in an MS attack phase
- Being diagnosed with sleep apnea or any sleep disorder
- Using sleeping pills
- Having a major psychiatric disorder
- Working a night shift job
- Having visual impairment
- Being younger than 18 or older than 80
- Not volunteering to participate in the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Erzurum Şehir Hastanesi
Erzurum, Karaman, (533) 935-2570, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- The person analyzing the statistics will not know which group is the experiment and which is the control group.
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Phd student
Study Record Dates
First Submitted
October 2, 2023
First Posted
October 10, 2023
Study Start
February 1, 2024
Primary Completion
September 1, 2024
Study Completion
November 20, 2024
Last Updated
January 24, 2025
Record last verified: 2025-01