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

NCT05332119 | Completed

• 1 other identifier: ICPS001/22
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain; Anxiety

Keywords

Virtual reality glasses

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (16)

• Sociodemographic and clinical factors

  Baseline

• Blood pressure

  Baseline

• Blood pressure

  1 minute after the removal of chest drains

• Blood pressure

  30 minutes after the removal of chest drains

• Heart rate

  Baseline

Study Arms (2)

Virtual reality

EXPERIMENTAL

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

Control group

SHAM COMPARATOR

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

Other: Control group

Interventions

VR glasses 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.

Virtual reality

Control group OTHER

Patients will not receive distraction during chest drain removal

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Gemma Via Clavero: lead

Study Sites (1)

Hospital Universitari de Bellvitge

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

Location

Related Publications (4)

• 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.

  PMID: 34163231 BACKGROUND

• 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.

  PMID: 30113379 BACKGROUND

• 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.

  PMID: 33347848 BACKGROUND

• 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.

  PMID: 33415290 BACKGROUND

MeSH Terms

Conditions

Pain; Anxiety Disorders

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PhD. Advanced Practice Critical Care Nurse

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

Study Record Dates

• First Submitted: April 4, 2022
• First Posted: April 18, 2022
• Study Start: April 1, 2021
• Primary Completion: March 15, 2023
• Study Completion: March 15, 2023
• Last Updated: March 28, 2023

Record last verified: 2023-03

Locations

ES (1)