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OpenTrials
Completed

NCT Number: NCT04464304

Virtual Reality for Postoperative Pain Management

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.

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Key information

Conditions

Surgery Incision Neurologic Manifestations Otolaryngological Disease Otorhinolaryngologic Diseases Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms Surgical Wound Wounds and Injuries

Age range

18 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Oregon Health and Science University

Portland, Oregon, 97239, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

smartphone

Device

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

Virtual Reality (Oculus Quest)

Device

Patients will participate in a game using VR.

Primary outcomes

  1. Change in patient-reported pain scores

    Time frame: Up to 4 hours after intervention use

    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 outcomes

  1. Opioid usage

    Time frame: Average 24 hours after intervention use

    Opioid use after intervention will be documented, measured in average morphine milligram equivalents (MME).

  2. Patient experience

    Time frame: Up to 4 hours after intervention use

    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."

Sponsors and collaborators

Lead sponsor

Oregon Health and Science University

Other

Registry information

Official study title

Virtual Reality for Postoperative Pain Management After Head and Neck Surgery: A Randomized Controlled Trial

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jul 9, 2020
Registry last updated
Oct 26, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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