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Virtual Reality for Postoperative Pain Management

Primary Purpose

Surgery, Pain, Postoperative, Incision

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Smartphone
Virtual Reality (Oculus Quest)
Sponsored by
Oregon Health and Science University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Surgery focused on measuring Virtual Reality

Eligibility Criteria

18 Years - 89 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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

Sites / Locations

  • Oregon Health and Science University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Virtual Reality

Smartphone

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Opioid usage
Opioid use after intervention will be documented, measured in average morphine milligram equivalents (MME).
Patient experience
Patients will complete a short survey at the completion of their participation in the study evaluating their audiovisual experience using a 5-point Likert scale, with responses ranging from "1 = Strongly Disagree" to "5 = Strongly Agree."

Full Information

First Posted
July 6, 2020
Last Updated
October 25, 2021
Sponsor
Oregon Health and Science University
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1. Study Identification

Unique Protocol Identification Number
NCT04464304
Brief Title
Virtual Reality for Postoperative Pain Management
Official Title
Virtual Reality for Postoperative Pain Management After Head and Neck Surgery: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
July 11, 2020 (Actual)
Primary Completion Date
October 20, 2021 (Actual)
Study Completion Date
October 20, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oregon Health and Science University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Management of postoperative pain after head and neck surgery is complex, and has received increased attention to improve patient recovery and quality of life. Narcotic analgesics are frequently utilized in postoperative pain management, but these have risks including nausea, sedation, constipation, and dependence. Multimodal analgesia can reduce narcotic use and improve recovery, but medical comorbidities may contraindicate the use of certain medications. Non-pharmacologic measures for postoperative pain control may provide novel and cost-effective strategies to confront this complex issue. Patients undergoing head and neck surgery will be randomly allocated to participate in an immersive experience in VR, or to participate in a similar experience on a two-dimensional screen using a smartphone.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgery, Pain, Postoperative, Incision, Otolaryngological Disease
Keywords
Virtual Reality

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Virtual Reality
Arm Type
Active Comparator
Arm Description
Patients will be provided with a commercially-available VR device for use up to 15 minutes at bedside.
Arm Title
Smartphone
Arm Type
Sham Comparator
Arm Description
Patients will be provided with a commercially-available smartphone device for use up to 15 minutes at bedside.
Intervention Type
Device
Intervention Name(s)
Smartphone
Intervention Description
Patients will participate in a similar game to the VR cohort, but will use a smartphone device.
Intervention Type
Device
Intervention Name(s)
Virtual Reality (Oculus Quest)
Intervention Description
Patients will participate in a game using VR.
Primary Outcome Measure Information:
Title
Change in patient-reported pain scores
Description
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.
Time Frame
Up to 4 hours after intervention use
Secondary Outcome Measure Information:
Title
Opioid usage
Description
Opioid use after intervention will be documented, measured in average morphine milligram equivalents (MME).
Time Frame
Average 24 hours after intervention use
Title
Patient experience
Description
Patients will complete a short survey at the completion of their participation in the study evaluating their audiovisual experience using a 5-point Likert scale, with responses ranging from "1 = Strongly Disagree" to "5 = Strongly Agree."
Time Frame
Up to 4 hours after intervention use

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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) Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ryan Li, MD
Organizational Affiliation
Oregon Health and Science University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oregon Health and Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35679057
Citation
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.
Results Reference
derived

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Virtual Reality for Postoperative Pain Management

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