Postoperative VR for Recovery After Bariatric Surgery

Beth Israel Lahey Health

Status: Active, not recruiting

Conditions: Postoperative Complications; Postoperative Pain; Bariatric Surgery Candidate

Treatments: Other: Virtual Reality Immersive Relaxation

Study type: Interventional

Funder types: Other

Identifiers

NCT04754165

2020P001149

Details and patient eligibility

About

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.

Full 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.

Enrollment: 106 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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• Surgery is converted to an open procedure (laparotomy), the patient will be withdrawn from the study as these patients are treated in a manner that is different than standard ERAS protocols

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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106 participants in 2 patient groups

Immersive Virtual Reality plus the enhanced recovery after surgery protocol

Experimental group

Description:

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.

Treatment:

Other: Virtual Reality Immersive Relaxation

Enhanced recovery after surgery protocol

No Intervention group

Description:

Subjects in the control group will only undergo standard enhanced recovery after surgery care.