Back to resultsResearch on Quantification of VR(Virtual Reality) Related Stress and Relaxation
Primary Purpose
Stress, Psychological, Motion Sickness, Visual Fatigue
Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Existing Biofeedback
Biofeedback accompanied with virtual reality
Sponsored by
About this trial
This is an interventional health services research trial for Stress, Psychological focused on measuring Stress, Virtual Reality, Motion sickness, Visual Fatigue, Biofeedback
Eligibility Criteria
Inclusion Criteria:
- scored at least 20 on the PSS-10 (Perceived Stress Scale 10) to verify highly psychological stressed participants at the baseline visits.
Exclusion Criteria:
- the existence of a current Major depressive disorder or panic disorder, psychotic disorder (e.g., schizophrenia or delusional disorder), bipolar affective disorder,active alcohol or drug use disorder, neurological illness including significant cognitive impairment or Parkinson's disease, mental retardation, significant medical conditions, epilepsy, histories of alcohol or drug dependence, personality disorders, or brain damages during the screening and baseline visits, per the Mini-International Neuropsychiatric Interview (Sheehan et al., 1998) according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5)
- the existence of active disease in both orbital parts
Sites / Locations
- Samsung Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
Stress relief with existing biofeedback
Stress relief with biofeedback and VR
Arm Description
After distressing virtual reality video and full resting time to relieve this stress, the investigators are going to give cognitive distress with serial seven, accompanied with existing biofeedback approach to relieve stress.
After distressing virtual reality video and full resting time to relieve this stress, the investigators are going to give cognitive distress with serial seven, accompanied with biofeedback combined to virtual reality relaxation.
Outcomes
Primary Outcome Measures
Change of Heart rate variability especially ratio of High Frequency and Low Frequency
Secondary Outcome Measures
Change of Respiration Rate
Psychological distress scale with Perceived Stress Scale 10
Visual analogue scale for motion sickness
Visual analogue scale for negative emotion
Visual analogue scale for visual fatigue
Full Information
NCT ID
NCT02986555
First Posted
December 2, 2016
Last Updated
December 6, 2016
Sponsor
Samsung Medical Center
Collaborators
Samsung Electronics
1. Study Identification
Unique Protocol Identification Number
NCT02986555
Brief Title
Research on Quantification of VR(Virtual Reality) Related Stress and Relaxation
Official Title
Virtual Reality Stress and Relief Project, Research on Quantification of VR Related Stress, Motion Sickness and Visual Fatigue
Study Type
Interventional
2. Study Status
Record Verification Date
December 2016
Overall Recruitment Status
Unknown status
Study Start Date
December 2016 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Samsung Medical Center
Collaborators
Samsung Electronics
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Current virtual reality device makes motion sickness and visual fatigue having limitation for recreation and other clinical approaches. Still there is no standardized quantification of motion sickness and visual fatigue measurement with objective approach. Current biofeedback accompanied with virtual reality would be promising tool for stress relief.
Detailed Description
Current virtual reality device makes motion sickness and visual fatigue having limitation for recreation and other clinical approaches. Still there is no standardized quantification of motion sickness and visual fatigue measurement with objective approach. After quantification and improvement with these shortcomings, current biofeedback accompanied with virtual reality would be promising tool for stress relief. This research aims to measure objective motion sickness and visual fatigue with psychological stress in highly stressed group, and to compare between stress relief with existing biofeedback only approach and relief with mixed biofeedback and virtual reality relaxation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress, Psychological, Motion Sickness, Visual Fatigue
Keywords
Stress, Virtual Reality, Motion sickness, Visual Fatigue, Biofeedback
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Stress relief with existing biofeedback
Arm Type
Placebo Comparator
Arm Description
After distressing virtual reality video and full resting time to relieve this stress, the investigators are going to give cognitive distress with serial seven, accompanied with existing biofeedback approach to relieve stress.
Arm Title
Stress relief with biofeedback and VR
Arm Type
Active Comparator
Arm Description
After distressing virtual reality video and full resting time to relieve this stress, the investigators are going to give cognitive distress with serial seven, accompanied with biofeedback combined to virtual reality relaxation.
Intervention Type
Device
Intervention Name(s)
Existing Biofeedback
Intervention Description
Using relaxing assisted biofeedback approach
Intervention Type
Device
Intervention Name(s)
Biofeedback accompanied with virtual reality
Intervention Description
Using relaxation approach with existing biofeedback accompanied by virtual reality relaxation
Primary Outcome Measure Information:
Title
Change of Heart rate variability especially ratio of High Frequency and Low Frequency
Time Frame
Baseline, after 64minutes and 30 seconds (which means cognitive distress stimuli,Serial Seven), after 85 minutes 30 seconds (after completing biofeedback or biofeedback with virtual reality relaxation)
Secondary Outcome Measure Information:
Title
Change of Respiration Rate
Time Frame
Baseline, after 64minutes and 30 seconds (which means cognitive distress stimuli,Serial Seven), after 85 minutes 30 seconds (after completing biofeedback or biofeedback with virtual reality relaxation)
Title
Psychological distress scale with Perceived Stress Scale 10
Time Frame
Baseline, after 64minutes and 30 seconds (which means cognitive distress stimuli,Serial Seven), after 85 minutes 30 seconds (after completing biofeedback or biofeedback with virtual reality relaxation)
Title
Visual analogue scale for motion sickness
Time Frame
Baseline, after 64minutes and 30 seconds (which means cognitive distress stimuli,Serial Seven), after 85 minutes 30 seconds (after completing biofeedback or biofeedback with virtual reality relaxation)
Title
Visual analogue scale for negative emotion
Time Frame
Baseline, after 64minutes and 30 seconds (which means cognitive distress stimuli,Serial Seven), after 85 minutes 30 seconds (after completing biofeedback or biofeedback with virtual reality relaxation)
Title
Visual analogue scale for visual fatigue
Time Frame
Baseline, after 64minutes and 30 seconds (which means cognitive distress stimuli,Serial Seven), after 85 minutes 30 seconds (after completing biofeedback or biofeedback with virtual reality relaxation)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
scored at least 20 on the PSS-10 (Perceived Stress Scale 10) to verify highly psychological stressed participants at the baseline visits.
Exclusion Criteria:
the existence of a current Major depressive disorder or panic disorder, psychotic disorder (e.g., schizophrenia or delusional disorder), bipolar affective disorder,active alcohol or drug use disorder, neurological illness including significant cognitive impairment or Parkinson's disease, mental retardation, significant medical conditions, epilepsy, histories of alcohol or drug dependence, personality disorders, or brain damages during the screening and baseline visits, per the Mini-International Neuropsychiatric Interview (Sheehan et al., 1998) according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5)
the existence of active disease in both orbital parts
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hong Jin Jeon, M.D.,Ph.D.
Phone
+82-2-3410-3586
Email
jhj001001@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hong Jin Jeon, M.D.,Ph.D.
Organizational Affiliation
Samsung Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Samsung Medical Center
City
Seoul
State/Province
Irwon-dong, Gangnam-gu
ZIP/Postal Code
135710
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hong Jin Jeon, MD, PhD
Phone
82-10-3198-3586
Email
jhj001001@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Research on Quantification of VR(Virtual Reality) Related Stress and Relaxation
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