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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age16-40
SponsorFilomena R B G Galas

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Visual impairments.

Cognitive impairment (MMSE ≤ 24).

Severe upper limb motor limitations.

Claustrophobia.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • 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.

Treatment groups

60 Participants
are divided into 3 treatment groups
Group A: Arm 1: Interactive Virtual RealityExperimental treatment 1 intervention
Group B: Arm 2: Passive Virtual RealityExperimental treatment 1 intervention
Group C: Arm 3: Standard Postoperative Care (Control)No intervention 0 interventions

Trial outcomes

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.

Time frame
From the end of surgery up to 5 days after surgery

Secondary outcomes

1

Occurrence of Nausea and Vomiting

Frequency of postoperative nausea and vomiting episodes

Time frame
Within 5 days after surgery
2

Length of ICU Stay

Number of days spent in the ICU

Time frame
Within 5 days after surgery
3

Length of Hospital Stay

Number of days hospitalized

Time frame
Within 30 days after surgery
4

Length of Mechanical Ventilation

Hours of mechanical ventilation

Time frame
Within 5 days after surgery

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Filomena R B G Galas

Lead sponsor

Instituto do Coracao

Sponsor institution