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

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

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.

Study Overview

• Status: Completed
• Conditions: Pain; Anxiety
• Intervention / Treatment: Device: VR glasses; Other: Control group

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 Type: Interventional
• Enrollment (Actual): 98
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Barcelona
    • L'Hospitalet De Llobregat, Barcelona, Spain, 08907
      • Hospital Universitari de Bellvitge

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: 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.
Sham Comparator: Control group; Patients in the control group will be cared for with the usual care protocol.	Other: Control group; Patients will not receive distraction during chest drain removal

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Gemma Via Clavero

Publications and helpful links

General Publications

• Devlin JW, Skrobik Y, Gelinas C, Needham DM, Slooter AJC, Pandharipande PP, Watson PL, Weinhouse GL, Nunnally ME, Rochwerg B, Balas MC, van den Boogaard M, Bosma KJ, Brummel NE, Chanques G, Denehy L, Drouot X, Fraser GL, Harris JE, Joffe AM, Kho ME, Kress JP, Lanphere JA, McKinley S, Neufeld KJ, Pisani MA, Payen JF, Pun BT, Puntillo KA, Riker RR, Robinson BRH, Shehabi Y, Szumita PM, Winkelman C, Centofanti JE, Price C, Nikayin S, Misak CJ, Flood PD, Kiedrowski K, Alhazzani W. Clinical Practice Guidelines for the Prevention and Management of Pain, Agitation/Sedation, Delirium, Immobility, and Sleep Disruption in Adult Patients in the ICU. Crit Care Med. 2018 Sep;46(9):e825-e873. doi: 10.1097/CCM.0000000000003299.
• Ioannou A, Papastavrou E, Avraamides MN, Charalambous A. Virtual Reality and Symptoms Management of Anxiety, Depression, Fatigue, and Pain: A Systematic Review. SAGE Open Nurs. 2020 Aug 27;6:2377960820936163. doi: 10.1177/2377960820936163. eCollection 2020 Jan-Dec.
• Nordness MF, Hayhurst CJ, Pandharipande P. Current Perspectives on the Assessment and Management of Pain in the Intensive Care Unit. J Pain Res. 2021 Jun 14;14:1733-1744. doi: 10.2147/JPR.S256406. eCollection 2021.
• Sadeghi AH, Mathari SE, Abjigitova D, Maat APWM, Taverne YJHJ, Bogers AJJC, Mahtab EAF. Current and Future Applications of Virtual, Augmented, and Mixed Reality in Cardiothoracic Surgery. Ann Thorac Surg. 2022 Feb;113(2):681-691. doi: 10.1016/j.athoracsur.2020.11.030. Epub 2020 Dec 19.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2021
• Primary Completion (Actual): March 15, 2023
• Study Completion (Actual): March 15, 2023

Study Registration Dates

• First Submitted: April 4, 2022
• First Submitted That Met QC Criteria: April 12, 2022
• First Posted (Actual): April 18, 2022

Study Record Updates

• Last Update Posted (Actual): March 28, 2023
• Last Update Submitted That Met QC Criteria: March 25, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Virtual reality glasses
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Critical Illness
• Other Study ID Numbers: ICPS001/22

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No