Utilization of Different Virtual Reality Experiences

Anxiety Clinical Trial

Official title:

Impact of Different Virtual Reality Experiences on Anxiety and Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04828980
• Other study ID #: 00022194
• Status: Completed
• Phase: N/A
• Start date: February 1, 2021
• Est. completion date: August 25, 2022

Study information

• Verified date: October 2023
• Source: Oregon Health and Science University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This trial studies differences between a mindfulness and a gaming virtual reality (VR) experience as a means for preoperative anxiety management and postoperative pain management among patients after head and neck surgery. Investigators will assess differences in anxiety scores, pain scores, physiologic measures, and subjective patient experiences.

Description:

Optimal postoperative pain control after head and neck surgery is vital for recovery, and non-pharmacologic strategies to improve pain may help reduce narcotic use. Further, preoperative anxiety is common and can impact postoperative pain, analgesic requirements, and recovery. In addition to facilitating with postoperative pain control, VR may have a role in reducing preoperative anxiety. However, it is unclear whether different VR experiences may be more beneficial for different clinical applications.

This study will evaluate if there are differences in preoperative anxiety and postoperative pain when utilizing different VR experiences. Patients undergoing head and neck surgery will be randomly allocated preoperatively to first participate in either a mindfulness or active gaming VR experience, and then postoperatively will crossover and participate in the other experience they did not utilize prior to surgery.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: August 25, 2022
• Est. primary completion date: April 11, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

Inclusion Criteria:

• Patients undergoing head and neck surgery

• Are able to provide informed consent

Exclusion Criteria:

• Isolation precautions

• Active eye discharge

• Active nausea or vomiting

• History of seizure, epilepsy, or hypersensitivity to flashing light

• Expected to have wounds or wound care that prevent comfortable and safe use of the VR headset

Related Conditions & MeSH terms

• Anxiety
• Otolaryngological Disease
• Otorhinolaryngologic Diseases
• Pain, Postoperative
• Surgery

Intervention

Device:
• Oculus Quest: TRIPP
This is a VR experience that focuses on meditation and mindfulness
• Oculus Quest: Angry Birds
This is an active gaming VR experience that utilizes controllers to aim and launch objects at targets.

Locations

Country	Name	City	State
United States	Oregon Health and Science University	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Oregon Health and Science University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in patient-reported anxiety	Anxiety level will be obtained using a 100mm Visual Analogue Scale (VAS). Preoperative anxiety scores will be obtained prior to VR then immmediately after VR use to assess change in anxiety after each intervention. Score will range from 0 (no anxiety) to 100 (extremely anxious)	baseline, and then 15 minutes later after VR use
Primary	Change in patient-reported pain	Pain level will be obtained using a 100mm Visual Analogue Scale (VAS). Postoperative pain scores will be obtained prior to VR then immmediately after VR use to assess change in pain level after each intervention. Score will range from 0 (no pain) to 100 (worst pain imaginable)	baseline, and then 15 minutes later after VR use
Secondary	Change in blood pressure	Blood pressure (mmHG) will be recorded prior to VR use and then after VR use to assess change in physiologic responses after each intervention.	baseline, and then 15 minutes later after VR use
Secondary	Patient experience	Patients will complete a short survey at the completion of their participation in each VR experience evaluating their experience using a 5-point Likert scale, with responses ranging from 1 (low satisfaction) to 5 (high satisfaction)	1 minute after use of VR
Secondary	Change in heart rate	Heart rate (beats per minute [bpm]) will be recorded prior to VR use and then after VR use to assess change in physiologic responses after each intervention.	baseline, and then 15 minutes later after VR use