Utilization of Different Virtual Reality Experiences

Not Applicable

Completed

• Conditions: Anxiety; Pain, Postoperative; Otolaryngological Disease; Surgery

• Registration Number: NCT04828980
• Lead Sponsor: Oregon Health and Science University

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2021-02-01
• Study First Submitted: 2021-03-28
• Study First Submitted QC: 2021-03-30
• Study First Posted: 2021-04-02
• Primary Completion: 2022-04-11
• Study Completion: 2022-08-25
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-30
• Last Update Posted: 2023-10-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Change in patient-reported anxiety	baseline, and then 15 minutes later after VR use	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)
Change in patient-reported pain	baseline, and then 15 minutes later after VR use	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)

Secondary Outcome Measures

Name	Time	Method
Patient experience	1 minute after use of VR	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)
Change in blood pressure	baseline, and then 15 minutes later after VR use	Blood pressure (mmHG) will be recorded prior to VR use and then after VR use to assess change in physiologic responses after each intervention.
Change in heart rate	baseline, and then 15 minutes later after VR use	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.

Trial Locations

Locations (1)

Oregon Health and Science University; 🇺🇸 Portland, Oregon, United States