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

Not Applicable

Completed

• Conditions: Pain; Anxiety
• Interventions: Device: VR glasses; Other: Control group

• Registration Number: NCT05332119
• Lead Sponsor: Gemma Via Clavero

Brief Summary

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

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)

Study Timeline

• Study Start: 2021-04-01
• Study First Submitted: 2022-04-04
• Study First Submitted QC: 2022-04-12
• Study First Posted: 2022-04-18
• Status Verified: 2023-03
• Primary Completion: 2023-03-15
• Study Completion: 2023-03-15
• Last Update Submitted: 2023-03-25
• Last Update Posted: 2023-03-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 98

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Virtual reality	VR glasses	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.
Control group	Control group	Patients in the control group will be cared for with the usual care protocol.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Hospital Universitari de Bellvitge; 🇪🇸 L'Hospitalet De Llobregat, Barcelona, Spain