Stress ReactionNCT07415239
Validity for Stress Reduction of Virtual Reality Intervention
A study testing virtual reality intervention in people with Stress Reaction, run by Seoul National University Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Stress Reaction
- What is being tested?
- virtual reality intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSouth Korea
- Study dates
- 6 Dec 2018to 31 Mar 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- age under 19 or over 65
- suffering from metabolic syndrome
- having psychosis usch as schizophrenia or bipolar disorder or a history of them
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13605
About this study
Official title: 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.
Read the 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.
- Conditions
- Stress Reaction
- Being tested
- virtual reality intervention, control intervention
- Keywords
- stress, cortisol, virtual reality
- Medical subject headings
- Fractures, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
virtual reality interventionBehavioural
VR intervention in a virtual seaside environment with congruent sounds.
control interventionBehavioural
reading materials of stress responses and recovery
| Study group | Role | What they receive |
|---|---|---|
| experimental | Experimental | Not described Receives: Behavioral: virtual reality intervention |
| active comparator | Active comparator | Not described Receives: Behavioral: control intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2026
- Study start6 Dec 2018
- Primary completion4 Jan 2019
- Study completion31 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress ReactionStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jeong-Hyun Kim, MD, PhD, Principal investigator, Seoul Naitonal University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07415239
- Sponsor's protocol ID
- B-1811-505-007
- Status last verified
- Jan 2019
- First submitted
- 4 Apr 2019
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validity for Stress Reduction of Virtual Reality Based Mental Health Care Service System
- ClinicalTrials.gov ID
- NCT07415239
- Acronym / sponsor ID
- B-1811-505-007
- Conditions
- Stress Reaction
- Keywords
- stress, cortisol, virtual reality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 6 Dec 2018 (actual)
- Primary completion
- 4 Jan 2019 (actual)
- Study completion
- 31 Mar 2019 (actual)
- First posted
- 17 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental | Experimental | Behavioral: virtual reality intervention |
| active comparator | Active comparator | Behavioral: control intervention |
Who may qualify
- Ages
- 19 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- age under 19 or over 65
- suffering from metabolic syndrome
- having psychosis usch as schizophrenia or bipolar disorder or a history of them
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| virtual reality interventionVR intervention in a virtual seaside environment with congruent sounds. | Behavioural | experimental |
| control interventionreading materials of stress responses and recovery | Behavioural | active comparator |
Primary outcome
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeong-Hyun Kim, MD, PhD principal investigator
Seoul Naitonal University Bundang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing virtual reality intervention in people with Stress Reaction, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2026.