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PainNCT05836649

Impact of Passive VR Versus Active VR on Heat Pain Thresholds and Pressure Pain Thresholds

A study testing Oculus Go headset without active intervention, Oculus Go headset with active intervention and Oculus Go headset without immersive virtual reality experience in people with Pain and Anxiety, run by Stanford University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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). Read more about this study

Who is it for?
Ages 18 to 99 yearsHealthy volunteers can take part
Conditions the study is for
Pain, Anxiety
What is being tested?
Oculus Go headset without active intervention, Oculus Go headset with active intervention and Oculus Go headset without immersive virtual reality experience
Could I receive a placebo?
No, everyone receives an active treatment
How many people
265 participants
Where
1 siteUnited States
Study dates
4 Aug 2023to 3 Jan 2024
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 18 to 99 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • greater than 18 years of age
  • English speaking
  • hearing intact

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Lucile Parkard Children's Hospital

    Stanford, California, 94304

Other trials in United States

About this study

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).

Read the 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.

Conditions
Pain, Anxiety
Being tested
Oculus Go headset without active intervention, Oculus Go headset with active intervention, Oculus Go headset without immersive virtual reality experience, Oculus Go headset with immersive virtual reality experience
Keywords
Thermal Sensory Analyzer (TSA-II), Peltier-Based Contact Thermode, Virtual Reality, Digital Algometer
Medical subject headings
Pain, Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Oculus Go headset without active interventionBehavioural

    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.

  • Oculus Go headset with active interventionBehavioural

    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.

  • Oculus Go headset without immersive virtual reality experienceBehavioural

    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.

  • Oculus Go headset with immersive virtual reality experienceBehavioural

    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.

Study groups in NCT05836649
Study groupRoleWhat they receive
Active VR then Passive VRExperimentalParticipant will conduct the Heat Pain Threshold experiment or Pressure Pain Threshold experiment using active VR first and then passive VR
Receives: Behavioral: Oculus Go headset without active intervention; Behavioral: Oculus Go headset with active intervention
Passive VR then Active VRExperimentalParticipant will conduct the Heat Pain Threshold experiment or Pressure Pain Threshold experiment using passive VR first and then active VR
Receives: Behavioral: Oculus Go headset without active intervention; Behavioral: Oculus Go headset with active intervention
No immersive virtual reality followed by immersive virtual realityExperimentalParticipant will conduct the Heat Pain Threshold experiment or Pressure Pain Threshold experiment using no immersive virtual reality first and then with immersive virtual reality.
Receives: Behavioral: Oculus Go headset without immersive virtual reality experience; Behavioral: Oculus Go headset with immersive virtual reality experience
Immersive virtual reality followed by No immersive virtual realityExperimentalParticipant will conduct the Heat Pain Threshold experiment or Pressure Pain Threshold experiment using immersive virtual reality first and then with no immersive virtual reality.
Receives: Behavioral: Oculus Go headset without immersive virtual reality experience; Behavioral: Oculus Go headset with immersive virtual reality experience

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in heat pain threshold

    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.

    Measured: Duration of intervention, approximately 15 minutes

Secondary outcomes (3)

  1. Change in pressure pain threshold

    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.

    Measured: Duration of intervention, approximately 15 minutes

  2. Change in recalled pain level

    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.

    Measured: immediately after intervention, 24 hours after the intervention

  3. Change in lower recalled fear/anxiety level

    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

    Measured: immediately after intervention, 24 hours after the intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 May 2023
  2. Study start4 Aug 2023
  3. Primary completion3 Jan 2024
  4. Study completion3 Jan 2024

Resources

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
Crossover
Masking
None (open label)
Enrolment
265 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05836649
Sponsor's protocol ID
69330
Status last verified
Jan 2026
First submitted
19 Apr 2023
Last updated
15 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 33495093

  • 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.

    PubMed 16697110

  • 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.

    PubMed 8199784

  • 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.

    PubMed 40117909

Questions about this trial

What is this clinical trial studying?

A study testing Oculus Go headset without active intervention, Oculus Go headset with active intervention and Oculus Go headset without immersive virtual reality experience in people with Pain and Anxiety, run by Stanford University at 1 site in United States.

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 6 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 15 Jan 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 United States. 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 heat pain threshold (time frame: Duration of intervention, approximately 15 minutes). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05836649, which also lists 4 linked publications.

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 15 Jan 2026.

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