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

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

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

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.
265

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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • 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

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
  • 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

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.
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
Behavioral: Oculus Go headset without active intervention
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.
Behavioral: Oculus Go headset with active intervention
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
Behavioral: Oculus Go headset without active intervention
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.
Behavioral: Oculus Go headset with active intervention
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.
Behavioral: Oculus Go headset without immersive virtual reality experience
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.
Behavioral: Oculus Go headset with immersive virtual reality experience
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.
Behavioral: Oculus Go headset without immersive virtual reality experience
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.
Behavioral: Oculus Go headset with immersive virtual reality experience
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

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 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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Stanford University

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

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.
August 4, 2023

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 3, 2024

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.
January 3, 2024

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 19, 2023

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.
April 19, 2023

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.
May 1, 2023

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.
January 15, 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.
January 13, 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, 2026

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.
  • 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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