Utilization of Different Virtual Reality Experiences

NCT ID: NCT04828980

Last Updated: 2023-10-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-01
• Study Completion Date: 2022-08-25

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.

Conditions

Surgery; Pain, Postoperative; Anxiety; Otolaryngological Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Mindfulness Virtual Reality Experience

Patients will be provided with a mindfulness VR experience for use up to 15 minutes at bedside.

Group Type: ACTIVE_COMPARATOR

Oculus Quest: TRIPP

Intervention Type: DEVICE

This is a VR experience that focuses on meditation and mindfulness

Gaming Virtual Reality Experience

Patients will be provided with an active gaming VR experience for use up to 15 minutes at bedside.

Group Type: ACTIVE_COMPARATOR

Oculus Quest: Angry Birds

Intervention Type: DEVICE

This is an active gaming VR experience that utilizes controllers to aim and launch objects at targets.

Interventions

Oculus Quest: TRIPP

This is a VR experience that focuses on meditation and mindfulness

Intervention Type: DEVICE

Oculus Quest: Angry Birds

This is an active gaming VR experience that utilizes controllers to aim and launch objects at targets.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Oregon Health and Science University

OTHER

Sponsor Role: lead

Responsible Party

Ryan Li, MD

Assistant Professor of Otolaryngology - Head and Neck Surgery, Division of Head and Neck Surgery, School of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ryan Li, MD

Role: PRINCIPAL_INVESTIGATOR

Oregon Health and Science University

Locations

Oregon Health and Science University

Portland, Oregon, United States

Countries

United States

Other Identifiers

00022194

Identifier Type: -

Identifier Source: org_study_id