Validity for Stress Reduction of Virtual Reality Intervention

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: Completed
• Conditions: Stress Reaction
• Intervention / Treatment: Behavioral: virtual reality intervention; Behavioral: control intervention

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: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
change in level of salivary cortisol	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	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

• Sponsor: Seoul National University Hospital
• Investigators: Principal Investigator: Jeong-Hyun Kim, MD, PhD, Seoul Naitonal University Bundang Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 6, 2018
• Primary Completion (Actual): January 4, 2019
• Study Completion (Actual): March 31, 2019

Study Registration Dates

• First Submitted: April 4, 2019
• First Submitted That Met QC Criteria: February 9, 2026
• First Posted (Actual): February 17, 2026

Study Record Updates

• Last Update Posted (Actual): February 17, 2026
• Last Update Submitted That Met QC Criteria: February 9, 2026
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: stress; virtual reality; cortisol
• Additional Relevant MeSH Terms: Wounds and Injuries; Fractures, Bone; Fractures, Stress
• Other Study ID 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