Research on Quantification of VR(Virtual Reality) Related Stress and Relaxation

December 6, 2016 updated by: Samsung Medical Center

Virtual Reality Stress and Relief Project, Research on Quantification of VR Related Stress, Motion Sickness and Visual Fatigue

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Irwon-dong, Gangnam-gu
      • Seoul, Irwon-dong, Gangnam-gu, Korea, Republic of, 135710
        • Recruiting
        • Samsung Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: HEALTH_SERVICES_RESEARCH
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Stress relief with existing biofeedback
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.
Device: Existing Biofeedback
Using relaxing assisted biofeedback approach
ACTIVE_COMPARATOR: Stress relief with biofeedback and VR
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.
Device: Biofeedback accompanied with virtual reality
Using relaxation approach with existing biofeedback accompanied by virtual reality relaxation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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)
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 Measures

Outcome Measure
Time Frame
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Samsung Medical Center

Collaborators

Samsung Electronics

Investigators

  • Principal Investigator: Hong Jin Jeon, M.D.,Ph.D., Samsung Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2016

Primary Completion (ANTICIPATED)

December 1, 2017

Study Completion (ANTICIPATED)

December 1, 2017

Study Registration Dates

First Submitted

December 2, 2016

First Submitted That Met QC Criteria

December 6, 2016

First Posted (ESTIMATE)

December 8, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

December 8, 2016

Last Update Submitted That Met QC Criteria

December 6, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016-10-007

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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