Bariatric Surgery CandidateNCT04754165
Postoperative VR for Recovery After Bariatric Surgery
A study testing Virtual Reality Immersive Relaxation in people with Bariatric Surgery Candidate and Postoperative Pain, run by Beth Israel Deaconess Medical Center at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bariatric Surgery Candidate, Postoperative Pain, Postoperative Complications
- What is being tested?
- Virtual Reality Immersive Relaxation
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Mar 2022to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing laparoscopic bariatric surgery at BIDMC under general anesthesia.
Who cannot join
- 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)
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- 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- Surgery is converted to an open procedure (laparotomy), the patient will be withdrawn from the study as these patients are treated in a manner that is different than standard ERAS protocols
Trial locations and contacts
1 site in 1 country.
United States1 site
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
About this study
Official title: Postoperative Virtual Reality (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.
Read the detailed description
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.
- Being tested
- Virtual Reality Immersive Relaxation
- Keywords
- Virtual Reality, ERAS
- Medical subject headings
- Pain, Postoperative, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality Immersive RelaxationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Immersive Virtual Reality plus the enhanced recovery after surgery protocol | Experimental | Patients in the immersive VR group will don a VR headset connected to a software platform on a tablet, as well as noise cancelling headphones in the post anesthesia care unit (PACU) after surgery. Patients can choose their desired experience within the VR software from a selection of immersive environments and/or video content. Examples include sitting in a canoe on a river, on a peaceful meadow or in a forest. Patients also have the option to listen to guided meditation or select from a library of videos to watch on a web-based user interface.
Patients in the VR group will also be treated according to the existing enhanced recovery after surgery protocol. Receives: Other: Virtual Reality Immersive Relaxation |
| Enhanced recovery after surgery protocol | No intervention | Subjects in the control group will only undergo standard enhanced recovery after surgery care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Recovery Questionnaires (QoR-15)
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.
Measured: Measured at time of post anesthesia care unit discharge, on average of 1 to 5 hours after surgery.
Secondary outcomes (7)
PACU Opioid Requirements
The postoperative opioid requirements following the patients surgery, will be measured in milligrams and converted to morphine dose equivalents.
Measured: Measured throughout a patient's stay in the post anesthesia care unit, on average 1 to 5 hours after surgery.
Length of PACU stay
The length of the patients stay in the Post Anesthesia Care Unit will be measured in minutes.
Measured: 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.
PACU pain scores using numeric rating scale
Clinically documented pain scores will be recorded on a scale from 0 (best outcome) to 10 (worst outcome).
Measured: 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.
Postoperative Quality of Recovery Questionnaires (QoR-15) score
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.
Measured: Measured at 24 hours after post anesthesia unit discharge.
Hospital length of stay
The length of the patients stay following surgery.
Measured: Measured throughout the patients stay at the hospital, on average 1 to 3 days.
Opioid requirements
Opioid requirements throughout the hospital stay.
Measured: Measured throughout the patients stay at the hospital, on average 1 to 3 days.
Opioid-related adverse effects
Opioid-related adverse effects such as nausea or ileus.
Measured: Measured throughout the patients stay at the hospital, on average 1 to 3 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2021
- Study start21 Mar 2022
- Primary completion1 Jun 2026
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bariatric Surgery CandidateStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Research participants will be randomized to one of two groups: immersive VR plus ERAS, or ERAS alone in a 1:1 allocation. The first 6 patients enrolled will be assigned to the VR group for the purposes of a pilot phase with the objective of identifying and refining any issues with the intervention. Data for these patients will not be included in the statistical analysis.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Israel-United States Binational Industrial Research and Development Foundation, XRHealth
- Responsible party
- Principal investigator, Brian O'Gara, Beth Israel Deaconess Medical Center
- Investigators
- Brian P O'Gara, MD,MP, Principal investigator, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04754165
- Sponsor's protocol ID
- 2020P001149
- Status last verified
- May 2026
- First submitted
- 29 Jan 2021
- Last updated
- 8 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Espinosa-Leon JP, Mathura R, Chen G, Joseph M, Sadhwani T, Beydoun N, Hernandez ER, Riley T, Goodspeed V, O'Gara BP. Postoperative virtual reality for recovery after bariatric surgery: study protocol for a randomised clinical trial. BJA Open. 2024 Feb 5;9:100258. doi: 10.1016/j.bjao.2024.100258. eCollection 2024 Mar.
PubMed 38333728
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Virtual Reality (VR) for Recovery After Bariatric Surgery
- ClinicalTrials.gov ID
- NCT04754165
- Acronym / sponsor ID
- 2020P001149
- Keywords
- Virtual Reality, ERAS
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Collaborators
- Israel-United States Binational Industrial Research and Development Foundation, XRHealth
- Study start
- 21 Mar 2022 (actual)
- Primary completion
- 1 Jun 2026 (actual)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 15 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Research participants will be randomized to one of two groups: immersive VR plus ERAS, or ERAS alone in a 1:1 allocation. The first 6 patients enrolled will be assigned to the VR group for the purposes of a pilot phase with the objective of identifying and refining any issues with the intervention. Data for these patients will not be included in the statistical analysis.
| Arm | Type | Receives |
|---|---|---|
| Immersive Virtual Reality plus the enhanced recovery after surgery protocol | Experimental | Other: Virtual Reality Immersive RelaxationPatients in the immersive VR group will don a VR headset connected to a software platform on a tablet, as well as noise cancelling headphones in the post anesthesia care unit (PACU) after surgery. Patients can choose their desired experience within the VR software from a selection of immersive environments and/or video content. Examples include sitting in a canoe on a river, on a peaceful meadow or in a forest. Patients also have the option to listen to guided meditation or select from a library of videos to watch on a web-based user interface. Patients in the VR group will also be treated according to the existing enhanced recovery after surgery protocol. |
| Enhanced recovery after surgery protocol | No intervention | –Subjects in the control group will only undergo standard enhanced recovery after surgery care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients undergoing laparoscopic bariatric surgery at BIDMC under general anesthesia.
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual Reality Immersive RelaxationThe 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. | Other | Immersive Virtual Reality plus the enhanced recovery after surgery protocol |
Primary outcome
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.
7 secondary outcomes
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.
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.
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.
Postoperative Quality of Recovery Questionnaires (QoR-15) score
Time frame: Measured at 24 hours after post anesthesia unit discharge.
Hospital length of stay
Time frame: Measured throughout the patients stay at the hospital, on average 1 to 3 days.
Opioid requirements
Time frame: Measured throughout the patients stay at the hospital, on average 1 to 3 days.
Opioid-related adverse effects
Time frame: Measured throughout the patients stay at the hospital, on average 1 to 3 days.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2026.
- Derived from this study: PubMed 38333728Espinosa-Leon JP, Mathura R, Chen G, Joseph M, Sadhwani T, Beydoun N, Hernandez ER, Riley T, Goodspeed V, O'Gara BP. Postoperative virtual reality for recovery after bariatric surgery: study protocol for a randomised clinical trial. BJA Open. 2024 Feb 5;9:100258. doi: 10.1016/j.bjao.2024.100258. eCollection 2024 Mar.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brian P O'Gara, MD,MP principal investigator
Beth Israel Deaconess Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality Immersive Relaxation in people with Bariatric Surgery Candidate and Postoperative Pain, run by Beth Israel Deaconess Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 8 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04754165, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2026.