NCT04464304

Brief Summary

This trial studies an active virtual reality (VR) experience as a means for non-pharmacologic postoperative pain management among patients after head and neck surgery. Investigators will assess differences in pain scores, analgesic use, and subjective patient experiences between patients participating in a VR activity and patients participating in the same activity using a smartphone.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable surgery

Timeline
Completed

Started Jul 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 6, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 9, 2020

Completed
2 days until next milestone

Study Start

First participant enrolled

July 11, 2020

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 20, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 20, 2021

Completed
Last Updated

October 26, 2021

Status Verified

October 1, 2021

Enrollment Period

1.3 years

First QC Date

July 6, 2020

Last Update Submit

October 25, 2021

Conditions

SurgeryPain, PostoperativeIncisionOtolaryngological Disease

Keywords

Virtual Reality

Outcome Measures

Primary Outcomes (1)

  • Change in patient-reported pain scores

    Pain scores will be obtained using an 11-point Numeric Rating Scale (NRS) prior to each intervention, immediately after the intervention, and then hourly up to 4 hours after the intervention to assess changes in pain scores after each intervention. A score of 0 signifies no pain, and a score of 10 signifies the highest severity of pain.

    Up to 4 hours after intervention use

Secondary Outcomes (2)

  • Opioid usage

    Average 24 hours after intervention use

  • Patient experience

    Up to 4 hours after intervention use

Study Arms (2)

Virtual Reality

ACTIVE COMPARATOR

Patients will be provided with a commercially-available VR device for use up to 15 minutes at bedside.

Device: Virtual Reality (Oculus Quest)

Smartphone

SHAM COMPARATOR

Patients will be provided with a commercially-available smartphone device for use up to 15 minutes at bedside.

Device: Smartphone

Interventions

SmartphoneDEVICE

Patients will participate in a similar game to the VR cohort, but will use a smartphone device.

Smartphone
Virtual Reality (Oculus Quest)DEVICE

Patients will participate in a game using VR.

Virtual Reality

Eligibility Criteria

Age18 Years - 89 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who have undergone head and neck surgery with an average pain score of 3 or greater out of 10 during the 24 hours preceding the screening
  • Are able to provide informed consent
  • Are not in the intensive care unit (ICU)

You may not qualify if:

  • Symptoms concerning for an active respiratory infection including fever, cough, and shortness of breath or confirmed respiratory infection
  • Active eye discharge
  • Active nausea or vomiting
  • History of seizure, epilepsy, or hypersensitivity to flashing light
  • History of motion sickness or vertigo
  • Have wound dressings on the head or neck that prevent comfortable and safe use of the virtual reality headset

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oregon Health and Science University

Portland, Oregon, 97239, United States

Location

Related Publications (1)

  • Pandrangi VC, Shah SN, Bruening JD, Wax MK, Clayburgh D, Andersen PE, Li RJ. Effect of Virtual Reality on Pain Management and Opioid Use Among Hospitalized Patients After Head and Neck Surgery: A Randomized Clinical Trial. JAMA Otolaryngol Head Neck Surg. 2022 Aug 1;148(8):724-730. doi: 10.1001/jamaoto.2022.1121.

    PMID: 35679057DERIVED

MeSH Terms

Conditions

Pain, PostoperativeSurgical WoundOtorhinolaryngologic Diseases

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and SymptomsWounds and Injuries

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
PARALLEL
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

July 6, 2020

First Posted

July 9, 2020

Study Start

July 11, 2020

Primary Completion

October 20, 2021

Study Completion

October 20, 2021

Last Updated

October 26, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)