NCT07415239

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 6, 2018

Completed
29 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 4, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2019

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

April 4, 2019

Completed
6.9 years until next milestone

First Posted

Study publicly available on registry

February 17, 2026

Completed
Last Updated

February 17, 2026

Status Verified

January 1, 2019

Enrollment Period

29 days

First QC Date

April 4, 2019

Last Update Submit

February 9, 2026

Conditions

Keywords

stresscortisolvirtual reality

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (2)

experimental

EXPERIMENTAL
Behavioral: virtual reality intervention

active comparator

ACTIVE COMPARATOR
Behavioral: control intervention

Interventions

reading materials of stress responses and recovery

active comparator

VR intervention in a virtual seaside environment with congruent sounds.

experimental

Eligibility Criteria

Age19 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 13605, South Korea

Location

MeSH Terms

Conditions

Fractures, Stress

Condition Hierarchy (Ancestors)

Fractures, BoneWounds and Injuries

Study Officials

  • Jeong-Hyun Kim, MD, PhD

    Seoul Naitonal University Bundang Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 4, 2019

First Posted

February 17, 2026

Study Start

December 6, 2018

Primary Completion

January 4, 2019

Study Completion

March 31, 2019

Last Updated

February 17, 2026

Record last verified: 2019-01

Locations