Validity for Stress Reduction of Virtual Reality Intervention

February 9, 2026 updated by: Seoul National University Hospital

Validity for Stress Reduction of Virtual Reality Based Mental Health Care Service System

The purpose of this study is to verify the effect of virtual reality (VR) intervention on stress reduction for workers. After inducing stress by the Socially Evaluated Cold Pressure Test (SECPT), Investigators should explore recovery of stress response in VR intervention and control condition. Healthy individuals were randomly assigned to one of VR intervention group and control group.

Study Overview

Status

Status

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

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

Investigators will assess whether subjective stress ratings and saliva cortisol elevations to the SECPT can be decreased by VR intervention more rapidly compared to control condition. After screening, pre-evaluation is conducted on healthy individuals who agreed to participate in the study. Experimental sessions run in the afternoon (between 14:00 and 17:00) in the virtual reality laboratory to control for diurnal cycle of cortisol. After arrival at the laboratory, participants were randomly assigned to one of two experimental conditions (VR intervention or control). At this point, psychological distress was recorded and baseline saliva sample was collected. After the first assessment, participants immersed their hand in ice water during 3 minutes and were watched by an unfamiliar person and videotaped during hand immersion. Immediately after participants took the SECPT, they rated on the Visual Analogue Scale (VAS) how stressful the previous situation had been and the second saliva sample was collected (the 2nd measurement). Thereafter, participants of VR intervention group go through VR intervention in a virtual seaside environment with congruent sounds, whereas those of control group are allowed to read materials of stress. Participants will be asked to collect their saliva and fill a VAS immeiately after the recovery period (the 3rd measurement) and 30 minutes after cessation of the stress manipulation (the 4th measurement). THe VR intervention is expected to cause more rapid recovery of stress responses than a control intervention.

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 (Actual)

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.
60

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

  • South Korea
    • Gyeonggi-do
      • Seongnam-si, Gyeonggi-do, South Korea, 13605
        • Seoul National University Bundang Hospital

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

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • workers over the age of 19 and under 65
  • healthy individuals without pathological problems of corisol levels such as Cushing's syndrome
  • being able to understand the protocol and voluntarliy agree to participate the study

Exclusion Criteria:

  • age under 19 or over 65
  • suffering from metabolic syndrome
  • having psychosis usch as schizophrenia or bipolar disorder or a history of them

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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

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.
Active Comparator: active comparator
Behavioral: control intervention
reading materials of stress responses and recovery
Experimental: experimental
Behavioral: virtual reality intervention
VR intervention in a virtual seaside environment with congruent sounds.

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
Measure Description
Time Frame
change in level of salivary cortisol
Time Frame: baseline, at the end of stress manipulation (3 minutes after the initiation of stress manipulation), immediately after intervention (5 minutes of intervention), 30 minutes after the end of stress manipulation
Saliva cortisol will be collected in sampling tubes with cotton swabs (Salivette®; Sarstedt, Leicester, UK) after Baseline, stress manipulation, intervention, and 30 minutes after stress provoking, for a total of four samples. The saliva cortisol is assessed with a competitive enzyme immunoassy (EIA) designed for quantitative in vitro measurement of cortisol in saliva (Spectria Cortisol Coated Tube RIA, Orion Diagnostica, Espoo, Finland) following the manufacturer's protocol.
baseline, at the end of stress manipulation (3 minutes after the initiation of stress manipulation), immediately after intervention (5 minutes of intervention), 30 minutes after the end of stress manipulation
change in subjectie stress ratings
Time Frame: baseline, at the end of stress manipulation (3 minutes after the initiation of stress manipulation), immediately after intervention (5 minutes of intervention), 30 minutes after the end of stress manipulation
Participants will be rated on the Visual Analogue Scale (VAS) how stressful they are at baseline, after stress manipulation, after recovery intervention, 30 minutes after stress manipulation.
baseline, at the end of stress manipulation (3 minutes after the initiation of stress manipulation), immediately after intervention (5 minutes of intervention), 30 minutes after the end of stress manipulation

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.
Seoul National University Hospital

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: Jeong-Hyun Kim, MD, PhD, Seoul Naitonal University Bundang Hospital

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 (Actual)

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 6, 2018

Primary Completion (Actual)

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.
January 4, 2019

Study Completion (Actual)

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.
March 31, 2019

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).
April 4, 2019

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.
February 9, 2026

First Posted (Actual)

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.
February 17, 2026

Study Record Updates

Last Update Posted (Actual)

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.
February 17, 2026

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.
February 9, 2026

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.
January 1, 2019

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.
  • B-1811-505-007

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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