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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05332119
• Other study ID #: ICPS001/22
• Status: Completed
• Phase: N/A
• Start date: April 1, 2021
• Est. completion date: March 15, 2023

Study information

• Verified date: March 2023
• Source: Hospital Universitari de Bellvitge
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 98
• Est. completion date: March 15, 2023
• Est. primary completion date: March 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Critical Illness
• Pain

Intervention

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.

Other:
• Control group
Patients will not receive distraction during chest drain removal

Locations

Country	Name	City	State
Spain	Hospital Universitari de Bellvitge	L'Hospitalet De Llobregat	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Gemma Via Clavero

Country where clinical trial is conducted

Spain, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Procedural pain score	Numerical rating scale (NRS). The pain can be scored from 0 to 10 (0=no pain, 10= worst possible pain)	Baseline
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Sociodemographic and clinical factors	Age, gender, past medical history	Baseline
Secondary	Blood pressure	Systolic, Diastolic and mean blood pressure measure in mmHg	Baseline
Secondary	Blood pressure	Systolic, Diastolic and mean blood pressure measure in mmHg	1 minute after the removal of chest drains
Secondary	Blood pressure	Number of systolic, diastolic and mean blood pressure measure in mmHg	30 minutes after the removal of chest drains
Secondary	Heart rate	Number in beats per minute	Baseline
Secondary	Heart rate	Number in beats per minute	1minute after the removal of chest drains
Secondary	Heart rate	Number in beats per minute	30 minutes after the removal of chest drains
Secondary	Respiratory rate	Number in breaths per minute	Baseline
Secondary	Respiratory rate	Number in breaths per minute	1 minute after the removal of chest drains
Secondary	Respiratory rate	Number in breaths per minute	30 minutes after the removal of chest drains
Secondary	Type of cardiac surgery	Type	Baseline
Secondary	Type of chest drains	Mediastinal or pleural drains	At baseline
Secondary	Number of chest drains	Number	At baseline
Secondary	Dose of analgesic drugs	Cumulated dose of analgesia drugs	1 hour before the procedure
Secondary	Patient satisfaction	Numerical Rating Scale (NRS). Patient's satisfaction will be scored from 0 to 4 (0= unsatisfied, 4=very satisfied).	30 minutes
Secondary	Adverse events	Type of adverse events experienced by patients	30 minutes