NCT06252025

Brief Summary

A VR game "Memo-gration" was designed to assist elderly people in reminiscence therapy. The ultimate scene design was crafted in a vintage Chinese aesthetic reminiscent of the previous century.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2023

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

January 24, 2024

Completed
16 days until next milestone

First Posted

Study publicly available on registry

February 9, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2024

Completed
Last Updated

April 28, 2026

Status Verified

April 1, 2024

Enrollment Period

1 year

First QC Date

January 24, 2024

Last Update Submit

April 25, 2026

Conditions

Keywords

Virtual RealityReminiscence Therapy

Outcome Measures

Primary Outcomes (1)

  • Profile of Mood States (POMS)

    POMS is utilized to evaluate alterations in affective state and cognitive state induced by short-term psychotherapy, emotional stimuli, etc.Participants assessed their present mental state using a 5-point Likert scale, comprising 40 questions that encompassed 7 subscales measuring tension, despair, weariness, and self-esteem, etc. A comprehensive mood disturbance score (TMD) was ultimately synthesized.

    baseline and 1 day (study completion)

Secondary Outcomes (1)

  • Questionnaire on VR Experience

    1 day (study completion)

Study Arms (2)

VR reminiscence therapy system "Memo-gration"

EXPERIMENTAL

This study tailored a variety of instructional material within each virtual scenario, taking into account various memory triggers. Guidance is activated when the user is identified as making physical contact with an object or discussing a specific keyword. This encompasses textual assistance provided within the virtual environment, the display of multimedia information, and the provision of organized voice guidance. Following the system's instructions, users engaged in discussion with the caregiver, and had the freedom to terminate the conversation at their discretion and explore other topics by interacting with different items.

Combination Product: Memo-gration

Picture reminiscence therapy

ACTIVE COMPARATOR

The picture reminiscence therapy group utilized a series of color images depicting screenshots of the Memo-gration, ensuring that the screenshots remained as consistent as feasible with the presented memory cues.

Other: Picture reminiscence therapy

Interventions

Memo-grationCOMBINATION_PRODUCT

This study tailored a variety of instructional material within each virtual scenario, taking into account various memory triggers. Guidance is activated when the user is identified as making physical contact with an object or discussing a specific keyword. This encompasses textual assistance provided within the virtual environment, the display of multimedia information, and the provision of organized voice guidance. Following the system's instructions, users engaged in discussion with the caregiver, and had the freedom to terminate the conversation at their discretion and explore other topics by interacting with different items.

VR reminiscence therapy system "Memo-gration"

Picture reminiscence therapy

Picture reminiscence therapy

Eligibility Criteria

Age60 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • (i) absence of significant cognitive impairment, visual impairment, hearing impairment, and communication ability.
  • (ii) Obtained the pre-test and watched the film while wearing a VR headgear without experiencing any notable discomfort.

You may not qualify if:

  • (i) Older adults with cognitive impairments that prevent normal communication
  • (ii) Visually impaired

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dian Zhu

Shanghai, Shanghai Municipality, 200140, China

Location

MeSH Terms

Conditions

Emotional Regulation

Condition Hierarchy (Ancestors)

Self-ControlSocial BehaviorBehavior

Study Officials

  • Dian Zhu, Dr

    Shanghai Jiao Tong University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 24, 2024

First Posted

February 9, 2024

Study Start

July 1, 2023

Primary Completion

July 1, 2024

Study Completion

August 1, 2024

Last Updated

April 28, 2026

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations