Evaluation of Virtual Reality for Reducing Opioid Use After Cardiac and Thoracic Surgery

NCT07063394 | Recruiting

• 1 other identifier: 6.889.108
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical trial aims to evaluate the efficacy of virtual reality (VR) as an adjunctive therapeutic method to reduce opioid consumption during the postoperative period of cardiac and thoracic surgeries. Conducted at InCor/HCFMUSP, this single-center, prospective, randomized trial will include 60 patients aged 16 to 40 undergoing procedures such as valve replacements, pulmonary decortication, and video-assisted thoracic surgeries. Patients will be randomized into three groups. The Interactive VR group receives standard anesthesia protocol combined with interactive VR therapy using games and immersive environments. The Passive VR group receives standard protocol combined with passive 360-degree immersive videos. The Control group receives standard anesthesia protocol without VR intervention. The intervention occurs in three daily sessions lasting 30-45 minutes each over the first five postoperative days or until hospital discharge. The primary objective is to measure the reduction in total opioid consumption through medical prescriptions and patient-controlled analgesia (PCA) pump usage. Secondary objectives include pain intensity assessed by the Visual Analogue Scale (VAS), incidence of postoperative nausea and vomiting (PONV), duration of mechanical and non-invasive ventilation, length of stay in the ICU and hospital, occurrence of paralytic ileus, patient satisfaction, and cognitive status using the Mini-Mental State Examination (MMSE). Opioids are standard for postoperative pain but are associated with adverse effects like respiratory depression. VR offers an innovative approach by creating immersive environments that serve as cognitive distractions to modulate pain perception and reduce anxiety. The study anticipates that VR will enhance pain control and improve recovery metrics, serving as a safe and scalable complement to traditional postoperative management.

Conditions

Heart Surgery; Opioid; Thoracic Surgery; Virtual Reality; Pain

Keywords

Heart surgery; Thoracic Surgery; Opioid; Virtual Reality; Pain

Outcome Measures

Primary Outcomes (1)

• Reduction in Opioid Consumption

  Measured by the total dose of opioids administered postoperatively, converted to Morphine Milligram Equivalents (MME), over the first 5 days.

  From the end of surgery up to 5 days after surgery

Secondary Outcomes (8)

• Occurrence of Nausea and Vomiting

  Within 5 days after surgery

• Length of ICU Stay

  Within 5 days after surgery

• Length of Hospital Stay

  Within 30 days after surgery

• Length of Mechanical Ventilation

  Within 5 days after surgery

• Length of Non-Invasive Ventilation

  Within 5 days after surgery

Study Arms (3)

Arm 1: Interactive Virtual Reality

EXPERIMENTAL

Participants in Arm 1 will receive standard postoperative care plus virtual reality (VR) therapy using both interactive games and passive imagery. The goal is to reduce opioid consumption and improve recovery through immersive distraction. VR sessions will be held three times daily, lasting 30-45 minutes each, for five consecutive postoperative days or until discharge. Games such as Fruit Ninja 2, Beat Saber, and Oculus First Contact offer stimulating experiences, while passive content from YouTube VR provides relaxing visual environments. Patients will be trained to operate the VR device and choose content based on their preference. All sessions will be supervised by the study team to ensure proper use and maximize therapeutic effect.

Device: Interactive Virtual Reality

Arm 2: Passive Virtual Reality

EXPERIMENTAL

Participants in Arm 2 will receive standard postoperative care plus virtual reality (VR) therapy focused solely on passive imagery for distraction. VR sessions will occur three times daily, each lasting 30-45 minutes, for five consecutive postoperative days or until discharge. Patients will view calming, immersive content-such as nature scenes and relaxing landscapes-available on platforms like YouTube VR. These experiences aim to reduce opioid consumption and improve recovery by decreasing pain perception. Participants will be trained to use the device and guided by the study team, who will supervise each session to ensure proper use and maximize therapeutic effect.

Device: Passive Virtual Reality

Arm 3: Standard Postoperative Care (Control)

NO INTERVENTION

Participants in Arm 3 will serve as the control group, receiving standard postoperative care without virtual reality (VR) intervention. Standard care includes institutional pain management protocols, such as the use of opioids and non-opioid analgesics after cardiac or thoracic surgery. No immersive or distraction-based technologies will be provided. This group serves as a baseline for comparison with the VR groups (Groups 1 and 2), enabling evaluation of the impact of VR on opioid consumption, pain perception, and recovery outcomes. Data from Group 3 will help assess the added value of VR as a complementary tool in postoperative care.

Interventions

Passive Virtual Reality DEVICE

Patients in the Passive VR arm will receive standard anesthesia protocol combined with passive Virtual Reality (VR) therapy. This involves the use of a VR headset to watch immersive 360-degree videos, such as tranquil natural landscapes or underwater scenes, designed to promote relaxation and reduce anxiety. The VR sessions do not require active participation, allowing patients to passively observe calming environments. The intervention will be administered for 3 sessions per day, lasting 30-45 minutes each, over 5 consecutive postoperative days.

Arm 2: Passive Virtual Reality

Interactive Virtual Reality DEVICE

Patients will utilize the Meta Quest 2 headset to engage in interactive applications requiring motor and cognitive tasks, such as Fruit Ninja 2 and Beat Saber, along with passive immersive software like Youtube VR. This dual approach combined with the institutional anesthesia protocol aims to maximize cognitive distraction. The intervention consists of three daily sessions of 30 to 45 minutes for five days postoperatively.

Arm 1: Interactive Virtual Reality

Eligibility Criteria

• Age: 16 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patients undergoing elective cardiac or thoracic surgeries at the Heart Institute (InCor) of the Hospital das Clínicas of the University of São Paulo.
• Eligible thoracic surgeries include: pulmonary decortication, thoracic sympathectomy, video-assisted thoracoscopic surgery (VATS), pulmonary biopsy, and pectus excavatum repair using the Nuss procedure.
• Patients aged between 16 and 40 years.
• Preserved cognitive function, indicated by a Mini-Mental State Examination (MMSE) score of ≥ 25.

You may not qualify if:

• Visual impairments.
• Cognitive impairment (MMSE ≤ 24).
• Severe upper limb motor limitations.
• Claustrophobia.
• Spatial disorientation.
• Motion sickness or vestibular disorders.
• Infectious or contagious diseases.

Sponsors & Collaborators

• Filomena R B G Galas: lead

Study Sites (1)

Incor - Heart Institute - University of Sao Paulo

São Paulo, São Paulo, 05403000, Brazil

RECRUITING

Related Publications (2)

• Kodvavi MS, Asghar MA, Ghaffar RA, Nadeem I, Bhimani S, Kumari V, Rabbani A, Iqbal M, Naeem R, Nasir AM, Hassan SS, Ghazni MS. Effectiveness of virtual reality in managing pain and anxiety in adults during periprocedural period: a systematic review and meta-analysis. Langenbecks Arch Surg. 2023 Aug 9;408(1):301. doi: 10.1007/s00423-023-03046-5.

  PMID: 37556082 RESULT

• Lind A, Ahsan M, Totzeck M, Al-Rashid F, Haddad A, Dubler S, Brenner T, Skarabis A, El Gabry M, Rassaf T, Janosi RA. Virtual reality-assisted distraction during transcatheter aortic valve implantation under local anaesthesia: A randomised study. Int J Cardiol. 2023 Sep 15;387:131130. doi: 10.1016/j.ijcard.2023.131130. Epub 2023 Jun 22.

  PMID: 37355243 RESULT

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Filomena Regina B. G. Galas, MD PhD

  Instituto do Coracao (InCor) - HCFMUSP

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Filomena Regina B Galas, PhD

CONTACT

+55 11 99319-0441; filomenagalas@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Anesthesiology

Model Details: This is a prospective, randomized, single-center, parallel-group trial with three arms. Participants undergoing elective cardiac or thoracic surgery will be randomized in a 1:1:1 ratio to receive: (1) standard postoperative care plus virtual reality (VR) with interactive games and/or passive imagery; (2) standard care plus VR with passive contemplative imagery only; or (3) standard postoperative care alone (control). The VR intervention will be administered over five consecutive postoperative days, with three supervised sessions per day, each lasting 30 to 45 minutes.

Study Record Dates

• First Submitted: July 3, 2025
• First Posted: July 14, 2025
• Study Start: December 10, 2024
• Primary Completion (Estimated): May 15, 2026
• Study Completion (Estimated): December 30, 2027
• Last Updated: April 15, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)