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

NCT ID: NCT02986555

Last Updated: 2016-12-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-31

Study Completion Date

2017-12-31

Brief Summary

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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

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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.

Conditions

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Stress, Psychological Motion Sickness Visual Fatigue

Keywords

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Stress Virtual Reality Motion sickness Visual Fatigue Biofeedback

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type PLACEBO_COMPARATOR

Existing Biofeedback

Intervention Type DEVICE

Using relaxing assisted biofeedback approach

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.

Group Type ACTIVE_COMPARATOR

Biofeedback accompanied with virtual reality

Intervention Type DEVICE

Using relaxation approach with existing biofeedback accompanied by virtual reality relaxation

Interventions

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Existing Biofeedback

Using relaxing assisted biofeedback approach

Intervention Type DEVICE

Biofeedback accompanied with virtual reality

Using relaxation approach with existing biofeedback accompanied by virtual reality relaxation

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Samsung Electronics

INDUSTRY

Sponsor Role collaborator

Samsung Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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

Role: PRINCIPAL_INVESTIGATOR

Samsung Medical Center

Locations

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Samsung Medical Center

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

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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

Role: CONTACT

Phone: +82-2-3410-3586

Email: [email protected]

Facility Contacts

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Hong Jin Jeon, MD, PhD

Role: primary

Other Identifiers

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2016-10-007

Identifier Type: -

Identifier Source: org_study_id