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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03799042
Other study ID # CUHKHKT0818
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 1, 2018
Est. completion date September 30, 2018

Study information

Verified date January 2019
Source Chinese University of Hong Kong
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 236
Est. completion date September 30, 2018
Est. primary completion date September 30, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 50 Years to 99 Years
Eligibility Inclusion Criteria:

- Native Cantonese Speaker

Exclusion Criteria:

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Virtual Reality
Subjects will wear a 3D glass and watch 3D pictures (or video) of landscapes or tourist sites in Hong Kong.
Behavioral:
Inter-generation interaction
Secondary school student will play games and chats with secondary school students. Games involve identifying famous landscapes or tourist sites in Hong Kong

Locations

Country Name City State
Hong Kong Caritas Elderly Centre - Sai Kung Hong Kong HK

Sponsors (1)

Lead Sponsor Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Simulator Sickness Questionnaire 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. 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 Positive and Negative Affect Schedule (PANAS) Measure the changes from baseline to first intervention Major assessment points are scheduled prior, post-intervention of first visit (approximate two hours after baseline)
Secondary Simulator Sickness Questionnaire Measure the changes from baseline to first intervention Major assessment points are scheduled prior, post-intervention of first visit (approximate two hours after baseline)
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