Virtual Reality During the Removal of Chest Drains in Critically-ill Patients

Gemma Via Clavero

Status: Completed

Conditions: Anxiety; Pain

Treatments: Other: Control group; Device: VR glasses

Study type: Interventional

Funder types: Other

Identifiers

NCT05332119

ICPS001/22

Details and patient eligibility

About

Appropriate pain and anxiety management of critically-ill patients during bedside procedures remains a big challenge. Clinical Practice Guidelines recommend preemptive analgesia or non-pharmacological interventions, such as relaxation techniques or distraction, to prevent and treat pain during nursing procedures. One of the most painful procedures in the Intensive Care Unit (ICU) is the removal of chest drains in post-cardiac surgical patients.

Virtual reality (VR) is a computer-generated simulation of a 360º immersive world in which the patient can receive visual and auditory stimuli that distract them from the real environment. Current research has demonstrated that VR reduced pain and anxiety in intravenous catheter insertions or wound care.

The primary objective of the study is to evaluate the effectiveness of VR on pain and anxiety during the removal of chest drains, in post-cardiac surgical patients. The hypothesis is that VR reduces both pain and anxiety, in critically-ill patients, during the removal of chest drains in post-cardiac surgical patients.

Full description

This is a prospective, randomized, open-label, prospective study of two parallel groups of patients during the removal of chest drains:

Group 1: removal of chest drains according to the usual management protocol.

Group 2: removal of chest drains according to the usual management protocol supplemented by the use of virtual reality glasses (VR glasses)

Enrollment: 98 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients ≥ 18 years old
• Patients with Richmond Agitation-Sedation Scale (RASS) between -1 to RASS +1
• Patients undergoing cardiac surgery
• Patients with chest drains
• Patients who voluntarily agree to participate (informed consent form)

Exclusion criteria

• Patients with a language barrier
• Patients with cognitive impairments
• Patients with neuromuscular blockers
• Patients with a previous history of documented anxiety
• Patients with epilepsy
• Hemodynamically unstable patients
• Face or ocular infections, with could contaminate VR glasses

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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98 participants in 2 patient groups

Virtual reality

Experimental group

Description:

The intervention will consist of the use of VR glasses during the removal of chest drains. The VR content has been developed by VR Pharma Immersive Technologies (LtD). Its main objective is to improve patient experience and have better management of pain and anxiety. Chest drains are removed following the usual protocol.

Treatment:

Device: VR glasses

Control group

Sham Comparator group

Description:

Patients in the control group will be cared for with the usual care protocol.

Treatment:

Other: Control group