RecruitingNot ApplicableNCT07063394

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

Evaluation of the Efficacy of Virtual Reality as a Therapeutic Method to Reduce Opioid Consumption in Postoperative Cardiac and Thoracic Surgery


Sponsor

Filomena R B G Galas

Enrollment

60 participants

Start Date

Dec 10, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 16 YearsMax Age: 40 Years

Inclusion Criteria4

  • 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.

Exclusion Criteria7

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

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Interventions

DEVICEInteractive Virtual Reality

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.

DEVICEPassive Virtual Reality

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.


Locations(1)

Incor - Heart Institute - University of Sao Paulo

São Paulo, São Paulo, Brazil

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NCT07063394


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