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

Samsung Medical Center

Status: Unknown

Conditions: Visual Fatigue; Motion Sickness; Stress, Psychological

Treatments: Device: Biofeedback accompanied with virtual reality; Device: Existing Biofeedback

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02986555

2016-10-007

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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80 participants in 2 patient groups, including a placebo group

Stress relief with existing biofeedback

Placebo Comparator group

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.

Treatment:

Device: Existing Biofeedback

Stress relief with biofeedback and VR

Active Comparator group

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.

Treatment:

Device: Biofeedback accompanied with virtual reality