- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03799042
The Use of Virtual Reality (VR) and the Change in Emotion in Hong Kong Elders
The Use of Virtual Reality (VR) and the Change in Emotional State in Hong Kong Elders
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
HK
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Hong Kong, HK, Hong Kong
- Caritas Elderly Centre - Sai Kung
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Native Cantonese Speaker
Exclusion Criteria:
-
Study Plan
How is the study designed?
Design Details
- Primary Purpose: OTHER
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Vitural Reality
Virtual Reality 3D glass
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Subjects will wear a 3D glass and watch 3D pictures (or video) of landscapes or tourist sites in Hong Kong.
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ACTIVE_COMPARATOR: Inter-generation interaction
Elders-teenager interaction
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Secondary school student will play games and chats with secondary school students.
Games involve identifying famous landscapes or tourist sites in Hong Kong
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Positive and Negative Affect Schedule (PANAS)
Time Frame: 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.)
|
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.
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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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Simulator Sickness Questionnaire
Time Frame: 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.)
|
Measure the difference in mean score between the two intervention groups.
The Simulator Sickness Questionnaire (SSQ) is consist of 16 symptoms.
Each symptom includes four level, none (0 marks), slight(1mark), moderate (2 marks) and severe(3).
Three subscore are included, Nausea-related subscore (Symptom 1,6,7,8,9,15,16), Oculomotor-related subscore (Symptom 1,2,3,4,5,9,11), and Disorientation-related subscore (5,8,10,11,12,13,14). Adding Nausea subscore, oculomotor subscore, and disorientation subscore and multiply by 3.74.
Total score larger than 15 indicated a significant level of adverse reaction.
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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)
Time Frame: Major assessment points are scheduled prior, post-intervention of first visit (approximate two hours after baseline)
|
Measure the changes from baseline to first intervention
|
Major assessment points are scheduled prior, post-intervention of first visit (approximate two hours after baseline)
|
|
Simulator Sickness Questionnaire
Time Frame: Major assessment points are scheduled prior, post-intervention of first visit (approximate two hours after baseline)
|
Measure the changes from baseline to first intervention
|
Major assessment points are scheduled prior, post-intervention of first visit (approximate two hours after baseline)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Kelvin KF Tsoi, BSc, PhD, Chinese University of Hong Kong
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- CUHKHKT0818
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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