- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06050772
Effect of Immersive Virtual Reality Reminiscence Versus Traditional Reminiscence Therapy on Cognitive Function and Psychological Wellbeing Among Institutionalized Older Adults: A Randomized Controlled Trial
September 18, 2023 updated by: Mahmoud Khedr, Alexandria University
Cognitive function and psychological wellbeing are basic determinants of successful ageing that enable older adults to maintain their health, independence, and autonomy.
Reminiscence therapy (RT) is one of the most prevalent evidence-based psychosocial interventions that can enhance older adults' cognitive function and maintain their psychological health.
Virtual reality (VR) reminiscence is an innovative strategy that has the advantage of integrating technology in to the care of institutionalized older adults.
However, limited researches have been conducted to compare the role of VR reminiscence versus traditional RT on improving older adult's cognitive and psychological wellbeing.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
The aim of this study is to determine the effect of virtual reality reminiscence versus traditional reminiscence therapy on cognitive function and psychological wellbeing among institutionalized older adults.
Study Type
Interventional
Enrollment (Estimated)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Damanhūr, Egypt
- Recruiting
- Faculty of Nursing, Damnhour university
-
Contact:
- Reem Basiouny
- Phone Number: +20 109 054 3550
- Email: reem.basiouny@nur.dmu.edu.eg
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- their age is 60 years and above, capable of communicating clearly, free form hearing or vision impairments that might hinder RT, and being able to tolerate using the Head Mounted Display(HMD) headset.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: STUDY GROUP
Groups who will receive virtual reality reminiscence versus traditional reminiscence therapy to determine its effect on cognitive function and psychological wellbeing.
|
a computer-generated environment using head-mounted displays (HMDs) that provide a fully immersive, completely engaging, and realistic experience so that users feel like they are a part of the virtual world
RT is a technique that encourages older adults' positive emotions and coping mechanisms by using the recall of earlier memories and the sharing of life experiences.
|
|
No Intervention: Control group
Groups who will not receive any intervention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
cognitive function
Time Frame: 3 months
|
The Mini-Mental State Examination (MMS) is recommended as an effective predictor of cognitive function of the elderly people .
It involves six cognitive related subscales with eleven questions investigating memory, concentration, orientation to time and place, registration, calculation, repetition, naming objects, language and recall.
|
3 months
|
|
Psychological Wellbeing
Time Frame: 3 months
|
The PWB measures six dimensions of psychological wellbeing among older adults including autonomy, environmental mastery, personal development, supportive relationships, purpose in life, and acceptance of oneself
|
3 months
|
|
Virtual Reality
Time Frame: 3 months
|
The CSQ-VR is a widely used scale to assess side effects of VR due to several advantages; it is easy applicable tool, it has clear questions and answers, its coring is simple and easy to understand, and its items cover all VR related symptoms.
|
3 months
|
|
Immersive Virtual Reality
Time Frame: 3 months
|
This questionnaire was adapted from the User eXperience in Immersive Virtual Environment Questionnaire (UX in IVEQ).
It was used to assess the participant's experience in immersive VR.
It is made up of 16 items which are distributed across 5 domains including presence (4 items), engagement (3 items), immersion (3 item), flow (3 items), and emotion (3 items).
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 20, 2023
Primary Completion (Estimated)
September 25, 2023
Study Completion (Estimated)
October 1, 2023
Study Registration Dates
First Submitted
September 17, 2023
First Submitted That Met QC Criteria
September 18, 2023
First Posted (Actual)
September 22, 2023
Study Record Updates
Last Update Posted (Actual)
September 22, 2023
Last Update Submitted That Met QC Criteria
September 18, 2023
Last Verified
September 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- 71-d
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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