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OpenTrials
Completed

NCT Number: NCT04828980

Utilization of Different Virtual Reality Experiences

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.

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Key information

Conditions

Surgery Anxiety Anxiety Disorders Mental Disorders Neurologic Manifestations Otolaryngological Disease Otorhinolaryngologic Diseases Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

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

Optimal postoperative pain control after head and neck surgery is vital for recovery, and non-pharmacologic strategies to improve pain may help reduce narcotic use. Further, preoperative anxiety is common and can impact postoperative pain, analgesic requirements, and recovery. In addition to facilitating with postoperative pain control, VR may have a role in reducing preoperative anxiety. However, it is unclear whether different VR experiences may be more beneficial for different clinical applications.

This study will evaluate if there are differences in preoperative anxiety and postoperative pain when utilizing different VR experiences. Patients undergoing head and neck surgery will be randomly allocated preoperatively to first participate in either a mindfulness or active gaming VR experience, and then postoperatively will crossover and participate in the other experience they did not utilize prior to surgery.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

Oculus Quest: TRIPP

Device

This is a VR experience that focuses on meditation and mindfulness

Oculus Quest: Angry Birds

Device

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

Primary outcomes

  1. Change in patient-reported anxiety

    Time frame: baseline, and then 15 minutes later after VR use

    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)

  2. Change in patient-reported pain

    Time frame: baseline, and then 15 minutes later after VR use

    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)

Secondary outcomes

  1. Change in blood pressure

    Time frame: baseline, and then 15 minutes later after VR use

    Blood pressure (mmHG) will be recorded prior to VR use and then after VR use to assess change in physiologic responses after each intervention.

  2. Patient experience

    Time frame: 1 minute after use of VR

    Patients will complete a short survey at the completion of their participation in each VR experience evaluating their experience using a 5-point Likert scale, with responses ranging from 1 (low satisfaction) to 5 (high satisfaction)

  3. Change in heart rate

    Time frame: baseline, and then 15 minutes later after VR use

    Heart rate (beats per minute [bpm]) will be recorded prior to VR use and then after VR use to assess change in physiologic responses after each intervention.

Sponsors and collaborators

Lead sponsor

Oregon Health and Science University

Other

Registry information

Official study title

Impact of Different Virtual Reality Experiences on Anxiety and Pain

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Apr 2, 2021
Registry last updated
Oct 31, 2023

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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