- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05836649
Impact of Passive VR Versus Active VR on Heat Pain Thresholds and Pressure Pain Thresholds
January 13, 2026 updated by: Thomas Caruso, Stanford University
This is a prospective, crossover study of healthy participants evaluating the impact of passive vs. active virtual reality (VR) games on heat pain threshold (HPT) and pressure pain threshold (PPT).
Study Overview
Status
Completed
Detailed Description
Virtual reality (VR) is an emerging, non-pharmaceutical intervention used to reduce perceived pain and anxiety in patients.
VR's effect on pain and anxiety on patients is well-studied as is how VR games improve recalled pain and anxiety in pediatric burn and bone-fracture patients undergoing painful medical procedures.
However, how differences in VR application construction (such as passive play vs. active play) impact patient perception of pain and anxiety is not well understood.
In this study, we will measure the impact of passive vs. active VR applications on heat pain threshold (HPT) and pressure pain threshold (PPT), and immediate vs. recalled pain and anxiety levels.
Study Type
Interventional
Enrollment (Actual)
265
Phase
- 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
-
-
California
-
Stanford, California, United States, 94304
- Lucile Parkard Children's 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
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- greater than 18 years of age
- English speaking
- hearing intact
Exclusion Criteria:
- a history of severe motion sickness
- currently have nausea
- history of seizures
- have hearing loss; are pregnant
- are currently taking beta blockers, chronotropic heart medications, or opioids or other prescription pain medications
- history of chronic pain or acute pain syndromes.
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: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Active VR then Passive VR
Participant will conduct the Heat Pain Threshold experiment or Pressure Pain Threshold experiment using active VR first and then passive VR
|
VR software with non-interactive content.
Heat pain threshold (HPT) and pressure pain threshold (PPT) depends on the HPT limits test or PPT limits test.
Participant will engage with the game display on the VR headset.
Heat pain threshold (HPT) and pressure pain threshold (PPT) depends on the HPT limits test or PPT limits test.
|
|
Experimental: Passive VR then Active VR
Participant will conduct the Heat Pain Threshold experiment or Pressure Pain Threshold experiment using passive VR first and then active VR
|
VR software with non-interactive content.
Heat pain threshold (HPT) and pressure pain threshold (PPT) depends on the HPT limits test or PPT limits test.
Participant will engage with the game display on the VR headset.
Heat pain threshold (HPT) and pressure pain threshold (PPT) depends on the HPT limits test or PPT limits test.
|
|
Experimental: No immersive virtual reality followed by immersive virtual reality
Participant will conduct the Heat Pain Threshold experiment or Pressure Pain Threshold experiment using no immersive virtual reality first and then with immersive virtual reality.
|
VR headset does not display any immersive virtual reality content.
Heat pain threshold (HPT) and pressure pain threshold (PPT) depends on the HPT limits test or PPT limits test.
VR headset displays immersive virtual reality content.
Heat pain threshold (HPT) and pressure pain threshold (PPT) depends on the HPT limits test or PPT limits test.
|
|
Experimental: Immersive virtual reality followed by No immersive virtual reality
Participant will conduct the Heat Pain Threshold experiment or Pressure Pain Threshold experiment using immersive virtual reality first and then with no immersive virtual reality.
|
VR headset does not display any immersive virtual reality content.
Heat pain threshold (HPT) and pressure pain threshold (PPT) depends on the HPT limits test or PPT limits test.
VR headset displays immersive virtual reality content.
Heat pain threshold (HPT) and pressure pain threshold (PPT) depends on the HPT limits test or PPT limits test.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in heat pain threshold
Time Frame: Duration of intervention, approximately 15 minutes
|
Heat pain threshold measured by the TSA Air II device.
Temperature ranges from 32 degrees C to 50 degrees C, with higher temperatures indicating a higher heat pain threshold.
|
Duration of intervention, approximately 15 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in pressure pain threshold
Time Frame: Duration of intervention, approximately 15 minutes
|
Pressure pain threshold measured by a computerized pressure pain algometer.
Pressure ranges from 0 kPa to 1000 kPa, with higher pressures indicating a higher pressure pain threshold.
|
Duration of intervention, approximately 15 minutes
|
|
Change in recalled pain level
Time Frame: immediately after intervention, 24 hours after the intervention
|
Recalled pain level measured by a numerical rating scale (NRS) from 0-10.
Scale ranges from 0-10, with higher scores indicating higher pain levels.
|
immediately after intervention, 24 hours after the intervention
|
|
Change in lower recalled fear/anxiety level
Time Frame: immediately after intervention, 24 hours after the intervention
|
Fear/anxiety level measure by the anxiety scale.
This scale ranges from 0-10, 0 meaning no anxiety and 10 indicating extreme or worst-possible anxiety
|
immediately after intervention, 24 hours after the intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Le May S, Hupin M, Khadra C, Ballard A, Paquin D, Beaudin M, Bouchard S, Cotes-Turpin C, Noel M, Guingo E, Hoffman HG, Dery J, Hung N, Perreault I. Decreasing Pain and Fear in Medical Procedures with a Pediatric Population (DREAM): A Pilot Randomized Within-Subject Trial. Pain Manag Nurs. 2021 Apr;22(2):191-197. doi: 10.1016/j.pmn.2020.10.002. Epub 2021 Jan 22.
- Price J, Sloman L, Gardner R Jr, Gilbert P, Rohde P. The social competition hypothesis of depression. Br J Psychiatry. 1994 Mar;164(3):309-15. doi: 10.1192/bjp.164.3.309.
- Rolke R, Baron R, Maier C, Tolle TR, Treede -DR, Beyer A, Binder A, Birbaumer N, Birklein F, Botefur IC, Braune S, Flor H, Huge V, Klug R, Landwehrmeyer GB, Magerl W, Maihofner C, Rolko C, Schaub C, Scherens A, Sprenger T, Valet M, Wasserka B. Quantitative sensory testing in the German Research Network on Neuropathic Pain (DFNS): standardized protocol and reference values. Pain. 2006 Aug;123(3):231-243. doi: 10.1016/j.pain.2006.01.041. Epub 2006 May 11.
- Rodriguez ST, Jimenez RT, Wang EY, Zuniga-Hernandez M, Titzler J, Jackson C, Suen MY, Yamaguchi C, Ko B, Kong JT, Caruso TJ. Virtual reality improves pain threshold and recall in healthy adults: A randomized, crossover study. J Clin Anesth. 2025 Apr;103:111816. doi: 10.1016/j.jclinane.2025.111816. Epub 2025 Mar 21.
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)
August 4, 2023
Primary Completion (Actual)
January 3, 2024
Study Completion (Actual)
January 3, 2024
Study Registration Dates
First Submitted
April 19, 2023
First Submitted That Met QC Criteria
April 19, 2023
First Posted (Actual)
May 1, 2023
Study Record Updates
Last Update Posted (Actual)
January 15, 2026
Last Update Submitted That Met QC Criteria
January 13, 2026
Last Verified
January 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 69330
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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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