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OpenTrials
Completed

NCT Number: NCT03744845

The Use of Virtual Reality to Reduce Anxiety and Pain in Perioperative Settings

We will investigate whether the use of Virtual Reality (VR) preoperatively and intraoperatively can help treat pain and anxiety, as measured by patient feedback, vital signs trends, and the amounts of anesthetics, pain medications and anxiolytics used during surgical procedures. The VR intervention will be studied during short hand surgeries normally performed using local anesthesia and sedation.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UCSF Orthopedic Institute

San Francisco, California, 94158, United States

About this study

Virtual Reality (VR) is a powerful and inexpensive technology that has been effectively used in healthcare settings to treat anxiety and pain, with minimal side effects. In the last two decades, opioid abuse and deaths related to opioids have increased, and opioid naive patients are at increased risk of opioid abuse when opioids are used during their surgical procedures. In addition, anesthetics, anxiolytics and analgesics, namely opioids, have a myriad of side effects that worsen patient experience, and lead to complications and increased costs. There are limited studies on the use of VR in the perioperative setting. Our study is a randomized controlled trial to investigate the use of VR to treat anxiety and pain in perioperative settings. We will recruit 56 patients, 28 in the control group and 28 in the VR group, undergoing short (<2 hrs) hand or upper extremity surgeries under local anesthesia and monitored anesthesia care (MAC). The control group will receive standard anesthetic management and the VR group will be exposed to VR in the preoperative setting and during the surgical procedure, using the clinically validated AppliedVR software. The data collected will included satisfaction questionnaires and pain scores for anxiety/pain pre- and post- procedure, vital signs trends to assess sympathetic response during surgery, and amount of anesthetics used. We hypothesize that the VR group will show decreased anxiety and pain, increased satisfaction, and decreased use of anesthetics during the procedure.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • 18 years old or older and less or equal to 75 years old.
  • ASA physical status I-II.
  • English speaking.
  • Undergoing elective surgery with local anesthetic with sedation.
  • Surgical time less than 2 hours.

Exclusion criteria

  • ASA physical status III or above.
  • Allergy to fentanyl, midazolam or propofol.
  • History of seizure, migraines.
  • Chronic Pain Syndrome.
  • Use of high dose opioids or long acting opioids.
  • Severe anxiety, on daily anxiolytics.
  • Psychiatric comorbidities that preclude the use of VR.
  • Physical disabilities that preclude the use of VR technology in a comfortable manner.
  • Patient refusal.

Treatment and study plan

Virtual Reality Distraction

Other

This RCT will utilize an Oculus Go VR headset that delivers VR images and sound. Users will wear the VR headset. A research coordinator will familiarize patients with hardware before use. The VR will be used preoperatively and intraoperatively to distracts patients, and aid with the treatment of pain and anxiety.

Primary outcomes

  1. Pre-Op Numeric Rating Scale for Pain

    Time frame: 1 minute during pre-op period

    Self-reported pain intensity pre- and post-operation. Each item is scored 0-10 (0 = no pain, 10 = pain as bad as it can be).

  2. Pre-Op Numeric Rating Scale for Anxiety

    Time frame: 1 minute during pre-op period

    Self-reported anxiety intensity pre-operation. Each item is scored 0-10 (0 = no anxiety, 10 = anxiety as bad as it can be).

  3. Post-Op Numeric Rating Scale for Pain

    Time frame: 1 minute during PACU stay

    Self-reported pain intensity post-operation. Each item is scored 0-10 (0 = no pain, 10 = pain as bad as it can be).

  4. Post-Op Numeric Rating Scale for Anxiety

    Time frame: 1 minute during PACU stay

    Self-reported anxiety intensity post-operation. Each item is scored 0-10 (0 = no anxiety, 10 = anxiety as bad as it can be).

  5. Preoperative Medication Dosage

    Time frame: up to 2 hours during pre-op period

    The amount of midazolam (milligrams [mg]), opioids (mg or micrograms [mcg]), propofol (mg), and other sedatives administered to the patient prior to surgery.

  6. Intraoperative Medication Dosage

    Time frame: up to 2 hours during surgery

    The amount of midazolam (milligrams [mg]), opioid (mg or micrograms [mcg]), propofol (mg), and other sedatives (mg) administered to the patient during surgery.

  7. Postoperative Medication Dosage

    Time frame: approximately 1 hour during PACU stay

    The amount of midazolam (milligrams [mg]), opioid (mg or micrograms [mcg]), propofol (mg), and other sedatives (mg) administered to the patient after surgery.

Secondary outcomes

  1. Blood Pressure

    Time frame: up to 2 hours during surgery

    Systolic and diastolic blood pressure (mmHg)

  2. Heart Rate

    Time frame: up to 2 hours during surgery

    Beats per minute (bpm)

  3. Satisfaction with Anesthesia Survey

    Time frame: 5 minutes during PACU stay

    An instrument that measures patient satisfaction with anesthesia care through open-ended and ranked response questions.

  4. Virtual Reality (VR) Survey

    Time frame: 5 minutes during PACU stay

    An instrument designed by study staff to collect information on patients' experience wearing the VR device. The 16-question survey utilizes free-responses, yes/no, and ranked responses.

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Registry information

Important dates

Study start
2018
Primary completion
2024
Study completion
2024
First posted
Nov 16, 2018
Registry last updated
Aug 10, 2026

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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