NCT06050772

Brief 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 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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

March 20, 2023

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 17, 2023

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 22, 2023

Completed
3 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 25, 2023

Completed
6 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2023

Completed
Last Updated

September 22, 2023

Status Verified

September 1, 2023

Enrollment Period

6 months

First QC Date

September 17, 2023

Last Update Submit

September 18, 2023

Conditions

Institutionalized Older Adults

Outcome Measures

Primary Outcomes (4)

  • 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.

    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

    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.

    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).

    3 months

Study Arms (2)

STUDY GROUP

EXPERIMENTAL

Groups who will receive virtual reality reminiscence versus traditional reminiscence therapy to determine its effect on cognitive function and psychological wellbeing.

Behavioral: Immersive Virtual Reality ReminiscenceBehavioral: Traditional Reminiscence Therapy

Control group

NO INTERVENTION

Groups who will not receive any intervention

Interventions

Immersive Virtual Reality ReminiscenceBEHAVIORAL

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

STUDY GROUP
Traditional Reminiscence TherapyBEHAVIORAL

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

Eligibility Criteria

Age60 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Nursing, Damnhour university

Damanhūr, Egypt

RECRUITING

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

September 17, 2023

First Posted

September 22, 2023

Study Start

March 20, 2023

Primary Completion

September 25, 2023

Study Completion

October 1, 2023

Last Updated

September 22, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)