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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Samsung Medical Center

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Samsung Electronics

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2016

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2017

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 2, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 6, 2016

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 8, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 8, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 6, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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