NCT06735352

Brief Summary

This study was conducted in a randomized controlled manner to investigate the effect of VR glasses on mild cognitive impairment in the elderly. The main questions the study aimed to answer are:

  • Will VR improve mild cognitive impairment in the elderly? The researchers used a control group to compare the effect of VR on mild cognitive impairment. Participants:
  • Before starting the study, the elderly were given the necessary forms and information.
  • The elderly were shown virtual reality videos with VR glasses 3 days a week for 4 weeks.
  • The control group did not watch any videos, and the post-test forms were filled out again for both groups at the end of 4 weeks.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2023

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

Study Start

First participant enrolled

December 1, 2023

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 5, 2024

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 16, 2024

Completed
Last Updated

December 16, 2024

Status Verified

December 1, 2024

Enrollment Period

9 months

First QC Date

December 5, 2024

Last Update Submit

December 13, 2024

Conditions

Keywords

elderlyvirtual realitymild cognitive impairmentnursing

Outcome Measures

Primary Outcomes (3)

  • Elderly Information Form

    The study includes questions to determine the age, gender, marital status, education level and chronic disease status of elderly individuals.

    4 week

  • Mini-Mental State Examination

    The MMSE, which provides assessment of cognitive status, was developed by Folstein and colleagues in 1975 and is the most commonly used and easily administered test in dementia screening (Folstein, 1975). Its validity and reliability in the diagnosis of mild dementia for the Turkish population was performed by Güngen and colleagues (Güngen 2002). The mini mental test is grouped under five main headings: orientation (10 points), recording memory (3 points), attention and calculation (5 points), recall (3 points) and language (9 points). The scale is evaluated out of a total of 30 points and has two different types for the educated and the uneducated. Traditionally, scores between 24 and 30 are considered normal. A score below 24 indicates cognitive impairment. A score between 18-23 points is considered mild dementia, 12-17 points is considered moderate dementia and 12 points below is considered severe dementia.

    4 week

  • Montreal Cognitive Assessment Scale

    It is a screening scale developed specifically to evaluate the early stages of cognitive impairment. The scale evaluates attention and concentration, executive functions, memory, language, visual and spatial skills, abstract thinking, calculation and orientation functions. The test takes approximately 10 minutes. The visual structuring skills test is worth 5 points, the attention test is worth 6 points, the language (naming) test is worth 6 points, the abstract thinking test is worth 2 points, the delayed recall is worth 5 points and the orientation test is worth 6 points. Patients with 21 points and above out of 30 points are considered cognitively normal.

    4 week

Study Arms (2)

Control Group

NO INTERVENTION

No intervention was made to the elderly in this group.

virtual reality group

EXPERIMENTAL

Evaluated the effect of using virtual reality in elderly people with mild cognitive impairment.

Other: virtual reality intervention

Interventions

Evaluated the effect of virtual reality use in elderly people with mild cognitive impairment compared to a control group.

virtual reality group

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • The study included elderly individuals who were over the age of 65,
  • Diagnosed with MCI by a neurologist,
  • Having a Standard Mini-Mental Statement (MMSE) score between 18 and 23,
  • Having a Montreal Cognitive Assessment Scale (MOCA) score below 21,
  • Able to communicate verbally,
  • Agreeing to participate in the study.

You may not qualify if:

  • The study excluded those with a history of stroke or epilepsy,
  • Those with other suspected degenerative diseases or diagnosed severe psychiatric illnesses,
  • Those with head trauma, thyroid disorders or other medical abnormalities that could impair cognitive function.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bayburt State Hospital

Bayburt, Centre, 69000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Study Officials

  • Buket DAŞTAN, Ph.D

    Karadeniz Tecnic University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assist. Prof. Dr.

Study Record Dates

First Submitted

December 5, 2024

First Posted

December 16, 2024

Study Start

December 1, 2023

Primary Completion

August 15, 2024

Study Completion

October 15, 2024

Last Updated

December 16, 2024

Record last verified: 2024-12

Locations