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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

98 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-01

Study Completion Date

2023-03-15

Brief Summary

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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.

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Detailed Description

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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)

Conditions

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Pain Anxiety

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Each patient will be randomized in a 1:1 ratio between the two arms of the study

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Virtual reality

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.

Group Type EXPERIMENTAL

VR glasses

Intervention Type DEVICE

Patients will watch a virtual world in VR glasses during the painful procedure. They will be able to choose between 3 VR content based on their preferences.

Control group

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

Group Type SHAM_COMPARATOR

Control group

Intervention Type OTHER

Patients will not receive distraction during chest drain removal

Interventions

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VR glasses

Patients will watch a virtual world in VR glasses during the painful procedure. They will be able to choose between 3 VR content based on their preferences.

Intervention Type DEVICE

Control group

Patients will not receive distraction during chest drain removal

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No