NCT03799042

Brief Summary

Virtual Reality (VR) is a technology that combines virtual technology and real-world scenario. In recent years, more and more neuroscience and psychology scientists utilised VR technology in their research. In Hong Kong, many of the community-dwelling elders are immobile. Long-term homestay may negatively affect the emotional state. Measuring the emotional change after administration of VR may prove it as an alternative tool for emotion intervention. The primary objective is to compare the improvement in the emotional changes between intergeneration interaction and the use of VR technology. The secondary objective is to evaluate the side effect after using VR technology. This is a randomized, open label-controlled trial with a crossover design. The subject will be randomized in a ratio of 1:1 into two different intervention groups, the VR group and the Intergeneration Interaction group. After 2 weeks of washout period, the VR group will receive Intergeneration Interaction and vice versa. The intervention phases last approximately 2 hours. The change in the emotional state will be assessed using the Positive and Negative Affect Scale. Any adverse event that causes by the VR will be recorded using the Simulator Sickness Questionnaire(SSQ). This trial is the first study in Hong Kong to investigate the change of emotional state after the administration of VR technology, targeting community-dwelling elders in Hong Kong.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
236

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2018

Shorter than P25 for not_applicable

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

August 1, 2018

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

August 10, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2018

Completed
3 months until next milestone

First Posted

Study publicly available on registry

January 10, 2019

Completed
Last Updated

January 10, 2019

Status Verified

January 1, 2019

Enrollment Period

2 months

First QC Date

August 10, 2018

Last Update Submit

January 7, 2019

Conditions

Virtual RealityEmotions

Outcome Measures

Primary Outcomes (1)

  • Positive and Negative Affect Schedule (PANAS)

    Measure the difference in mean score between the two intervention groups. The Positive and Negative Affect Schedule (PANAS) is consist of 20 emotions. Positive Affect Score consists of 10 positive emotions, while Negative Affect Score consists of 10 negative emotions. Positive Affect Score ranges from 10 to 50, a score of 30 indicates a higher level of positive emotion. Negative Affect Score ranges from 10 to 50, a score of 15 indicates a higher level of negative emotion. Total PANAS score is 100, added up by both Positive Affect Score and Negative Affect Score.

    Major assessment points are scheduled prior to intervention(baseline), post intervention of the first visit (approximate 2 hours after baseline), and post intervention of the second visit (2 weeks after first intervention.)

Secondary Outcomes (3)

  • Simulator Sickness Questionnaire

    Major assessment points are scheduled prior to intervention(baseline), post intervention of the first visit (approximate 2 hours after baseline), and post intervention of the second visit (2 weeks after first intervention.)

  • Positive and Negative Affect Schedule (PANAS)

    Major assessment points are scheduled prior, post-intervention of first visit (approximate two hours after baseline)

  • Simulator Sickness Questionnaire

    Major assessment points are scheduled prior, post-intervention of first visit (approximate two hours after baseline)

Study Arms (2)

Vitural Reality

EXPERIMENTAL

Virtual Reality 3D glass

Device: Virtual Reality

Inter-generation interaction

ACTIVE COMPARATOR

Elders-teenager interaction

Behavioral: Inter-generation interaction

Interventions

Virtual RealityDEVICE

Subjects will wear a 3D glass and watch 3D pictures (or video) of landscapes or tourist sites in Hong Kong.

Vitural Reality
Inter-generation interactionBEHAVIORAL

Secondary school student will play games and chats with secondary school students. Games involve identifying famous landscapes or tourist sites in Hong Kong

Inter-generation interaction

Eligibility Criteria

Age50 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Native Cantonese Speaker

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Caritas Elderly Centre - Sai Kung

Hong Kong, HK, Hong Kong

Location

Study Officials

  • Kelvin KF Tsoi, BSc, PhD

    Chinese University of Hong Kong

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

August 10, 2018

First Posted

January 10, 2019

Study Start

August 1, 2018

Primary Completion

September 30, 2018

Study Completion

September 30, 2018

Last Updated

January 10, 2019

Record last verified: 2019-01

Locations

HK(1)