Institutionalized Older AdultsNCT06050772
Effect of Immersive Virtual Reality Reminiscence Versus Traditional Reminiscence Therapy on Cognitive Function and Psychological Wellbeing Among Institutionalized Older Adults: A Randomized Controlled Trial
A study testing Immersive Virtual Reality Reminiscence and Traditional Reminiscence Therapy in people with Institutionalized Older Adults, run by Alexandria University at 1 site in Egypt.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 60 to 90 years
- Conditions the study is for
- Institutionalized Older Adults
- What is being tested?
- Immersive Virtual Reality Reminiscence and Traditional Reminiscence Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Mar 2023to 1 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Nursing, Damnhour university
Damanhūr
Reem Basiouny, +20 109 054 3550, reem.basiouny@nur.dmu.edu.eg
About this study
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.
Read the 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.
- Conditions
- Institutionalized Older Adults
- Being tested
- Immersive Virtual Reality Reminiscence, Traditional Reminiscence Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immersive Virtual Reality ReminiscenceBehavioural
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
Traditional Reminiscence TherapyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| STUDY GROUP | Experimental | Groups who will receive virtual reality reminiscence versus traditional reminiscence therapy to determine its effect on cognitive function and psychological wellbeing. Receives: Behavioral: Immersive Virtual Reality Reminiscence; Behavioral: Traditional Reminiscence Therapy |
| Control group | No intervention | Groups who will not receive any intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
cognitive function
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.
Measured: 3 months
Psychological Wellbeing
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
Measured: 3 months
Virtual Reality
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.
Measured: 3 months
Immersive Virtual Reality
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).
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2023
- Study start20 Mar 2023
- Primary completion25 Sep 2023 (estimated)
- Study completion1 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Institutionalized Older AdultsStudies of the same condition, open and under way.
- More trials run by Alexandria UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Khedr, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06050772
- Sponsor's protocol ID
- 71-d
- Status last verified
- Sep 2023
- First submitted
- 17 Sep 2023
- Last updated
- 22 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Immersive Virtual Reality Reminiscence Versus Traditional Reminiscence Therapy on Cognitive Function and Psychological Wellbeing Among Institutionalized Older Adults: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06050772
- Acronym / sponsor ID
- 71-d
- Conditions
- Institutionalized Older Adults
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 20 Mar 2023 (actual)
- Primary completion
- 25 Sep 2023 (estimated)
- Study completion
- 1 Oct 2023 (estimated)
- First posted
- 22 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| STUDY GROUP | Experimental | Behavioral: Immersive Virtual Reality Reminiscence, Behavioral: Traditional Reminiscence TherapyGroups who will receive virtual reality reminiscence versus traditional reminiscence therapy to determine its effect on cognitive function and psychological wellbeing. |
| Control group | No intervention | –Groups who will not receive any intervention |
Who may qualify
- Ages
- 60 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Immersive Virtual Reality Reminiscencea 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 | Behavioural | STUDY GROUP |
| Traditional Reminiscence TherapyRT 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. | Behavioural | STUDY GROUP |
Primary outcome
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.
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
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.
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).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Immersive Virtual Reality Reminiscence and Traditional Reminiscence Therapy in people with Institutionalized Older Adults, run by Alexandria University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cognitive function (time frame: 3 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2023.