Passive VS Active VR on HPT Using the Thermal Sensory Analyzer With a Peltier-Based Contact Thermode

Pain Clinical Trial

Official title:

Impact of Passive VR Versus Active VR on Heat Pain Thresholds Using the Thermal Sensory Analyzer (TSA-II) With a Peltier-Based Contact Thermode

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05836649
• Other study ID #: 69330
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2023
• Est. completion date: July 31, 2024

Study information

• Verified date: April 2023
• Source: Stanford University
• Contact: Samuel Rodriguez, MD
• Phone: 650-723-5728
• Email: sr1[@]stanford.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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).

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 immediate vs. recalled pain and anxiety levels.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: July 31, 2024
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety
• Pain

Intervention

Behavioral:
• Oculus Go headset without active intervention
VR software with non-interactive content.
• Oculus Go headset with active intervention
Participant will engage with the game display on the VR headset. Engagement time depends on the HPT limits test.

Locations

Country	Name	City	State
United States	Lucile Parkard Children's Hospital	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. Erratum In: Pain. 2006 Nov;125(1-2):197. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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.	Duration of intervention, approximately 15 minutes
Secondary	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.	24 hours after the intervention
Secondary	Change in lower recalled fear/anxiety level	Lower recalled fear/anxiety level measure by the adapted Fear Questionnaire (FQ). This scale ranges from 0-8, 0 indicating participants would not avoid the situation in the future, and 8 meaning they would always avoid the situation in the future.	24 hours after the intervention