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

NCT ID: NCT05836649

Last Updated: 2025-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

265 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-04

Study Completion Date

2024-01-03

Brief Summary

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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).

Detailed Description

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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

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Pain Anxiety

Keywords

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Thermal Sensory Analyzer (TSA-II) Peltier-Based Contact Thermode Virtual Reality Digital Algometer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Oculus Go headset without active intervention

Intervention Type BEHAVIORAL

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 intervention

Intervention Type BEHAVIORAL

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.

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

Group Type EXPERIMENTAL

Oculus Go headset without active intervention

Intervention Type BEHAVIORAL

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 intervention

Intervention Type BEHAVIORAL

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.

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.

Group Type EXPERIMENTAL

Oculus Go headset without immersive virtual reality experience

Intervention Type BEHAVIORAL

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 experience

Intervention Type BEHAVIORAL

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.

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.

Group Type EXPERIMENTAL

Oculus Go headset without immersive virtual reality experience

Intervention Type BEHAVIORAL

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 experience

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Stanford University

OTHER

Sponsor Role lead

Responsible Party

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Thomas Caruso

Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Lucile Parkard Children's Hospital

Stanford, California, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 33495093 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16697110 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 8199784 (View on PubMed)

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.

Reference Type DERIVED
PMID: 40117909 (View on PubMed)

Other Identifiers

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69330

Identifier Type: -

Identifier Source: org_study_id