NCT06074419

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

87
On Track

Trial Health Score

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

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 2, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 10, 2023

Completed
4 months until next milestone

Study Start

First participant enrolled

February 1, 2024

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 20, 2024

Completed
Last Updated

January 24, 2025

Status Verified

January 1, 2025

Enrollment Period

7 months

First QC Date

October 2, 2023

Last Update Submit

January 21, 2025

Conditions

Keywords

VİRTUAL REALİTYSLEEP QUALITYMENTAL WELL-BEINGMULTIPLE SCLEROSISNURSING

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

EXPERIMENTAL

Virtual 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.

Device: Occulus quest 2 virtual reality glasses

Control group

NO INTERVENTION

There 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.

Experimental group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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)

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance DisordersPsychological Well-BeingMultiple Sclerosis

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental DisordersPersonal SatisfactionBehaviorDemyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

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
Model Details: The experimental group will be shown a nature video through virtual reality glasses. No action will be applied to the control group. The two groups will be compared in terms of sleep quality and mental well-being
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

Locations