Virtual RealityNCT03799042
The Use of Virtual Reality (VR) and the Change in Emotion in Hong Kong Elders
A study testing Virtual Reality and Inter-generation interaction in people with Virtual Reality and Emotions, run by Chinese University of Hong Kong at 1 site in Hong Kong.
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. Read more about this study
- Who is it for?
- Ages 50 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Virtual Reality, Emotions
- What is being tested?
- Virtual Reality and Inter-generation interaction
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 236 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Aug 2018to 30 Sep 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Native Cantonese Speaker
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
- Conditions
- Virtual Reality, Emotions
- Being tested
- Virtual Reality, Inter-generation interaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual RealityDevice
Subjects will wear a 3D glass and watch 3D pictures (or video) of landscapes or tourist sites in Hong Kong.
Inter-generation interactionBehavioural
Secondary school student will play games and chats with secondary school students. Games involve identifying famous landscapes or tourist sites in Hong Kong
| Study group | Role | What they receive |
|---|---|---|
| Vitural Reality | Experimental | Virtual Reality 3D glass Receives: Device: Virtual Reality |
| Inter-generation interaction | Active comparator | Elders-teenager interaction Receives: Behavioral: Inter-generation interaction |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 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)
Measure the changes from baseline to first intervention
Measured: Major assessment points are scheduled prior, post-intervention of first visit (approximate two hours after baseline)
Simulator Sickness Questionnaire
Measure the changes from baseline to first intervention
Measured: Major assessment points are scheduled prior, post-intervention of first visit (approximate two hours after baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2019
- Study start1 Aug 2018
- Primary completion30 Sep 2018
- Study completion30 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Virtual RealityStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 236 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kelvin KF Tsoi, Chinese University of Hong Kong
- Investigators
- Kelvin KF Tsoi, BSc, PhD, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03799042
- Sponsor's protocol ID
- CUHKHKT0818
- Status last verified
- Jan 2019
- First submitted
- 10 Aug 2018
- Last updated
- 10 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Virtual Reality (VR) and the Change in Emotional State in Hong Kong Elders
- ClinicalTrials.gov ID
- NCT03799042
- Acronym / sponsor ID
- CUHKHKT0818
- Conditions
- Virtual Reality, Emotions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 236 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 30 Sep 2018 (actual)
- Study completion
- 30 Sep 2018 (actual)
- First posted
- 10 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitural Reality | Experimental | Device: Virtual RealityVirtual Reality 3D glass |
| Inter-generation interaction | Active comparator | Behavioral: Inter-generation interactionElders-teenager interaction |
Who may qualify
- Ages
- 50 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Native Cantonese Speaker
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual RealitySubjects will wear a 3D glass and watch 3D pictures (or video) of landscapes or tourist sites in Hong Kong. | Device | Vitural Reality |
| Inter-generation interactionSecondary school student will play games and chats with secondary school students. Games involve identifying famous landscapes or tourist sites in Hong Kong | Behavioural | Inter-generation interaction |
Primary outcome
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.
3 secondary outcomes
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.)
Positive and Negative Affect Schedule (PANAS)
Time frame: 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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2019.
Related trials for Virtual Reality
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruiting
Virtual Reality Multidomain Training for Older Adults With Cognitive Frailty
Cognitive Frailty
Not yet recruiting
Virtual Reality Training Dose for Arm Recovery After Stroke: Clinical and Blood Biomarker Responses
Stroke, Upper Extremity Paresis
Recruiting
Virtual Reality in Rehabilitation of Executive Functions in Children With Mild or Moderate Traumatic Brain Injury
Traumatic Brain Injury
Not yet recruiting
Advancing Cardiovascular Health Among Adolescents With Intellectual Disabilities: Co-Development of Technology Interventions to Enhance Physical Activity
Physical Activity, Intellectual Disabilities
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kelvin KF Tsoi, BSc, PhD principal investigator
Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality and Inter-generation interaction in people with Virtual Reality and Emotions, run by Chinese University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2019.