NCT05836649

Brief 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
265

participants targeted

Target at P75+ for not_applicable pain

Timeline
Completed

Started Aug 2023

Shorter than P25 for not_applicable pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 19, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

May 1, 2023

Completed
3 months until next milestone

Study Start

First participant enrolled

August 4, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 3, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 3, 2024

Completed
Last Updated

January 15, 2026

Status Verified

January 1, 2026

Enrollment Period

5 months

First QC Date

April 19, 2023

Last Update Submit

January 13, 2026

Conditions

PainAnxiety

Keywords

Thermal Sensory Analyzer (TSA-II)Peltier-Based Contact ThermodeVirtual RealityDigital Algometer

Outcome Measures

Primary Outcomes (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.

    Duration of intervention, approximately 15 minutes

Secondary Outcomes (3)

  • Change in pressure pain threshold

    Duration of intervention, approximately 15 minutes

  • Change in recalled pain level

    immediately after intervention, 24 hours after the intervention

  • Change in lower recalled fear/anxiety level

    immediately after intervention, 24 hours after the intervention

Study Arms (4)

Active VR then Passive VR

EXPERIMENTAL

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 interventionBehavioral: Oculus Go headset with active intervention

Passive VR then Active VR

EXPERIMENTAL

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 interventionBehavioral: Oculus Go headset with active intervention

No immersive virtual reality followed by immersive virtual reality

EXPERIMENTAL

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 experienceBehavioral: Oculus Go headset with immersive virtual reality experience

Immersive virtual reality followed by No immersive virtual reality

EXPERIMENTAL

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 experienceBehavioral: Oculus Go headset with immersive virtual reality experience

Interventions

Oculus Go headset without active interventionBEHAVIORAL

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.

Active VR then Passive VRPassive VR then Active VR
Oculus Go headset without immersive virtual reality experienceBEHAVIORAL

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.

Immersive virtual reality followed by No immersive virtual realityNo immersive virtual reality followed by immersive virtual reality
Oculus Go headset with immersive virtual reality experienceBEHAVIORAL

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 realityNo immersive virtual reality followed by immersive virtual reality
Oculus Go headset with active interventionBEHAVIORAL

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.

Active VR then Passive VRPassive VR then Active VR

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lucile Parkard Children's Hospital

Stanford, California, 94304, United States

Location

Related Publications (4)

  • 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.

    PMID: 33495093BACKGROUND

  • 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.

    PMID: 16697110BACKGROUND

  • 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.

    PMID: 8199784BACKGROUND

  • 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.

    PMID: 40117909DERIVED

MeSH Terms

Conditions

PainAnxiety Disorders

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

April 19, 2023

First Posted

May 1, 2023

Study Start

August 4, 2023

Primary Completion

January 3, 2024

Study Completion

January 3, 2024

Last Updated

January 15, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)