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

NCT02986555 | Unknown

• 1 other identifier: 2016-10-007
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Stress, Psychological; Motion Sickness; Visual Fatigue

Keywords

Stress; Virtual Reality; Motion sickness; Visual Fatigue; Biofeedback

Outcome Measures

Primary Outcomes (1)

• Change of Heart rate variability especially ratio of High Frequency and Low Frequency

  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 Outcomes (5)

• Change of Respiration Rate

  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

  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

  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

  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

  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)

Study Arms (2)

Stress relief with existing biofeedback

PLACEBO COMPARATOR

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

Stress relief with biofeedback and VR

ACTIVE COMPARATOR

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

Interventions

Existing Biofeedback DEVICE

Using relaxing assisted biofeedback approach

Stress relief with existing biofeedback

Biofeedback accompanied with virtual reality DEVICE

Using relaxation approach with existing biofeedback accompanied by virtual reality relaxation

Stress relief with biofeedback and VR

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• scored at least 20 on the PSS-10 (Perceived Stress Scale 10) to verify highly psychological stressed participants at the baseline visits.

You may not qualify if:

• 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

Sponsors & Collaborators

• Samsung Medical Center: lead
• Samsung Electronics: collaborator

Study Sites (1)

Samsung Medical Center

Seoul, Irwon-dong, Gangnam-gu, 135710, South Korea

RECRUITING

MeSH Terms

Conditions

Stress, Psychological; Motion Sickness; Asthenopia

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Eye Diseases

Study Officials

• Hong Jin Jeon, M.D.,Ph.D.

  Samsung Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hong Jin Jeon, M.D.,Ph.D.

CONTACT

+82-2-3410-3586; jhj001001@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2016
• First Posted: December 8, 2016
• Study Start: December 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: December 8, 2016

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)