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Virtual Reality for Postoperative Pain Management

NCT ID: NCT04464304

Last Updated: 2021-10-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-11

Study Completion Date

2021-10-20

Brief Summary

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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

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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.

Conditions

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Surgery Pain, Postoperative Incision Otolaryngological Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Virtual Reality

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

Group Type ACTIVE_COMPARATOR

Virtual Reality (Oculus Quest)

Intervention Type DEVICE

Patients will participate in a game using VR.

Smartphone

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

Group Type SHAM_COMPARATOR

Smartphone

Intervention Type DEVICE

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

Interventions

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Smartphone

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

Intervention Type DEVICE

Virtual Reality (Oculus Quest)

Patients will participate in a game using VR.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

89 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Oregon Health and Science University

OTHER

Sponsor Role lead

Responsible Party

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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

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Ryan Li, MD

Role: PRINCIPAL_INVESTIGATOR

Oregon Health and Science University

Locations

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Oregon Health and Science University

Portland, Oregon, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 35679057 (View on PubMed)

Other Identifiers

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00020777

Identifier Type: -

Identifier Source: org_study_id