Utilization of Different Virtual Reality Experiences

NCT04828980 | Completed

• 1 other identifier: 00022194
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Surgery; Pain, Postoperative; Anxiety; Otolaryngological Disease

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (3)

• Change in blood pressure

  baseline, and then 15 minutes later after VR use

• Patient experience

  1 minute after use of VR

• Change in heart rate

  baseline, and then 15 minutes later after VR use

Study Arms (2)

Mindfulness Virtual Reality Experience

ACTIVE COMPARATOR

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

Device: Oculus Quest: TRIPP

Gaming Virtual Reality Experience

ACTIVE COMPARATOR

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

Device: Oculus Quest: Angry Birds

Interventions

Oculus Quest: TRIPP DEVICE

This is a VR experience that focuses on meditation and mindfulness

Mindfulness Virtual Reality Experience

Oculus Quest: Angry Birds DEVICE

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

Gaming Virtual Reality Experience

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing head and neck surgery
• Are able to provide informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Oregon Health and Science University: lead

Study Sites (1)

Oregon Health and Science University

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Pain, Postoperative; Anxiety Disorders; Otorhinolaryngologic Diseases

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Mental Disorders

Study Officials

• Ryan Li, MD

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

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

Study Record Dates

• First Submitted: March 28, 2021
• First Posted: April 2, 2021
• Study Start: February 1, 2021
• Primary Completion: April 11, 2022
• Study Completion: August 25, 2022
• Last Updated: October 31, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)