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

Study Overview
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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.

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)

Official Title
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Effectiveness of Virtual Reality on Pain and Anxiety During the Removal of Chest Drains in Critically-ill Patients

Conditions
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Pain, Anxiety

Intervention / Treatment
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* Device: VR glasses
* Other: Control group


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Each patient will be randomized in a 1:1 ratio between the two arms of the study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Virtual reality<br>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. | Device: VR glasses<br>* 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.<br>|
| Sham Comparator: Control group<br>Patients in the control group will be cared for with the usual care protocol. | Other: Control group<br>* Patients will not receive distraction during chest drain removal<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedural pain score | Numerical rating scale (NRS). The pain can be scored from 0 to 10 (0=no pain, 10= worst possible pain) | Baseline | 
| Procedural pain score | Numerical rating scale (NRS). The pain can be scored from 0 to 10 (0=no pain, 10= worst possible pain) | 1 minute after the removal of chest drains | 
| Procedural pain score | Numerical rating scale (NRS). The pain can be scored from 0 to 10 (0=no pain, 10= worst possible pain) | 30 minutes after the removal of chest drains | 
| Procedural anxiety score | State-Trait Anxiety Inventory (STAI scale)- trait state. The anxiety can be scored from 0 to 60 (0=no anxiety, 60=worst possible anxiety) | Baseline | 
| Procedural anxiety score | State-Trait Anxiety Inventory (STAI scale)- trait state. The anxisety can be scored from 0 to 60 (0=no anxiety, 60=worst possible anxiety) | 1 minute after the removal of chest drains | 
| Procedural anxiety score | State-Trait Anxiety Inventory (STAI scale)- trait state. The anxisety can be scored from 0 to 60 (0=no anxiety, 60=worst possible anxiety) | 30 minutes after the removal of chest drains | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sociodemographic and clinical factors | Age, gender, past medical history | Baseline | 
| Blood pressure | Systolic, Diastolic and mean blood pressure measure in mmHg | Baseline | 
| Blood pressure | Systolic, Diastolic and mean blood pressure measure in mmHg | 1 minute after the removal of chest drains | 
| Blood pressure | Number of systolic, diastolic and mean blood pressure measure in mmHg | 30 minutes after the removal of chest drains | 
| Heart rate | Number in beats per minute | Baseline | 
| Heart rate | Number in beats per minute | 1minute after the removal of chest drains | 
| Heart rate | Number in beats per minute | 30 minutes after the removal of chest drains | 
| Respiratory rate | Number in breaths per minute | Baseline | 
| Respiratory rate | Number in breaths per minute | 1 minute after the removal of chest drains | 
| Respiratory rate | Number in breaths per minute | 30 minutes after the removal of chest drains | 
| Type of cardiac surgery | Type | Baseline | 
| Type of chest drains | Mediastinal or pleural drains | At baseline | 
| Number of chest drains | Number | At baseline | 
| Dose of analgesic drugs | Cumulated dose of analgesia drugs | 1 hour before the procedure | 
| Patient satisfaction | Numerical Rating Scale (NRS). Patient's satisfaction will be scored from 0 to 4 (0= unsatisfied, 4=very satisfied). | 30 minutes | 
| Adverse events | Type of adverse events experienced by patients | 30 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Virtual reality glasses