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NCT Number: NCT04754165

Postoperative VR for Recovery After Bariatric Surgery

The objective of this study is to investigate whether the addition of immersive virtual reality (VR) in the immediate postoperative period to an enhanced recovery after surgery (ERAS) protocol could improve postoperative recovery from bariatric surgery.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Bariatric Surgery Candidate Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Postoperative Pain Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

About this study

The investigators propose conducting a randomized, controlled, single-center clinical trial of patients recovering from laparoscopic bariatric surgery. The objective is to investigate whether the use of virtual reality (VR) during the immediate postoperative period could improve patient reported quality of recovery and potentially reduce opioid analgesic requirements as compared to an existing ERAS protocol.

The investigators hypothesize that immersive VR will improve subjective quality of recovery scores at time of Post Anesthesia Care Unit (PACU) discharge as compared to standard ERAS.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients undergoing laparoscopic bariatric surgery at BIDMC under general anesthesia.

Exclusion criteria

  • Age<18
  • Open wounds or active infection of the face or eye area
  • History of seizures or other symptom linked to an epileptic condition
  • Patients with hearing aids who are unable to tolerate wearing headphones with their hearing aids
  • Patients with a pacemaker or other implanted medical device
  • Droplet or airborne precautions (as determined by BIDMC infection control policy)
  • Non English Speaking or non Spanish Speaking
  • Chronic opioid dependence (existing oral opioid prescription for >3 months, methadone, suboxone)

Drop Out Criteria: (after enrollment and randomization, before intervention)

  • Surgery is converted to an open procedure (laparotomy), the patient will be withdrawn from the study as these patients are treated in a manner that is different than standard ERAS protocols

Treatment and study plan

Virtual Reality Immersive Relaxation

Other

The VR software developed allows patients to select from scenery such as mountains, the beach or from a selection of short videos, which are intended to promote relaxation.

Primary outcomes

  1. Quality of Recovery Questionnaires (QoR-15)

    Time frame: Measured at time of post anesthesia care unit discharge, on average of 1 to 5 hours after surgery.

    The primary outcome of this study will be patient reported quality of recovery at time of PACU discharge, as assessed by the QOR-15. The QOR-15 is a validated instrument to assess postoperative recovery from the patient's perspective, assessing overall well-being, nausea, pain, and anxiety and depression following surgery.

Secondary outcomes

  1. PACU Opioid Requirements

    Time frame: Measured throughout a patient's stay in the post anesthesia care unit, on average 1 to 5 hours after surgery.

    The postoperative opioid requirements following the patients surgery, will be measured in milligrams and converted to morphine dose equivalents.

  2. Length of PACU stay

    Time frame: Duration of the patient's stay in the post anesthesia care unit, from time of admission to time of readiness for PACU discharge, on average 1 to 5 hours.

    The length of the patients stay in the Post Anesthesia Care Unit will be measured in minutes.

  3. PACU pain scores using numeric rating scale

    Time frame: Administered every hour following admission to the post anesthesia care unit until discharge from the post anesthesia care unit, on average 1 to 5 hours.

    Clinically documented pain scores will be recorded on a scale from 0 (best outcome) to 10 (worst outcome).

  4. Postoperative Quality of Recovery Questionnaires (QoR-15) score

    Time frame: Measured at 24 hours after post anesthesia unit discharge.

    The QOR-15 is a validated instrument to assess postoperative recovery from the patient's perspective, assessing overall well-being, nausea, pain, and anxiety and depression following surgery.

  5. Hospital length of stay

    Time frame: Measured throughout the patients stay at the hospital, on average 1 to 3 days.

    The length of the patients stay following surgery.

  6. Opioid requirements

    Time frame: Measured throughout the patients stay at the hospital, on average 1 to 3 days.

    Opioid requirements throughout the hospital stay.

  7. Opioid-related adverse effects

    Time frame: Measured throughout the patients stay at the hospital, on average 1 to 3 days.

    Opioid-related adverse effects such as nausea or ileus.

Sponsors and collaborators

Lead sponsor

Beth Israel Deaconess Medical Center

Other

Collaborators

  • Israel-United States Binational Industrial Research and Development Foundation
  • XRHealth

Registry information

Official study title

Postoperative Virtual Reality (VR) for Recovery After Bariatric Surgery

Important dates

Study start
2022
Primary completion
2026
Study completion
2027
First posted
Feb 15, 2021
Registry last updated
Jul 8, 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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