Clinical trial NCT05332119: Virtual Reality During the Removal of Chest Drains in Critically-ill Patients
Official title: Effectiveness of Virtual Reality on Pain and Anxiety During the Removal of Chest Drains in Critically-ill Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Anxiety
Keywords: Virtual reality glasses
Lead sponsor: Hospital Universitari de Bellvitge
Sponsor class: OTHER
First posted: 2022-04-18
Enrollment: 98
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Each patient will be randomized in a 1:1 ratio between the two arms of the study
Primary purpose: SUPPORTIVE_CARE

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)

Eligibility criteria: 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

Primary outcomes:
measure: Procedural pain score
timeFrame: Baseline
measure: Procedural pain score
timeFrame: 1 minute after the removal of chest drains
measure: Procedural pain score
timeFrame: 30 minutes after the removal of chest drains
measure: Procedural anxiety score
timeFrame: Baseline
measure: Procedural anxiety score
timeFrame: 1 minute after the removal of chest drains
measure: Procedural anxiety score
timeFrame: 30 minutes after the removal of chest drains
Secondary outcomes:
measure: Sociodemographic and clinical factors
timeFrame: Baseline
measure: Blood pressure
timeFrame: Baseline
measure: Blood pressure
timeFrame: 1 minute after the removal of chest drains
measure: Blood pressure
timeFrame: 30 minutes after the removal of chest drains
measure: Heart rate
timeFrame: Baseline
measure: Heart rate
timeFrame: 1minute after the removal of chest drains
measure: Heart rate
timeFrame: 30 minutes after the removal of chest drains
measure: Respiratory rate
timeFrame: Baseline
measure: Respiratory rate
timeFrame: 1 minute after the removal of chest drains
measure: Respiratory rate
timeFrame: 30 minutes after the removal of chest drains
measure: Type of cardiac surgery
timeFrame: Baseline
measure: Type of chest drains
timeFrame: At baseline
measure: Number of chest drains
timeFrame: At baseline
measure: Dose of analgesic drugs
timeFrame: 1 hour before the procedure
measure: Patient satisfaction
timeFrame: 30 minutes
measure: Adverse events
timeFrame: 30 minutes
Other outcomes:
Locations:
city: L'Hospitalet De Llobregat
country: Spain
facility: Hospital Universitari de Bellvitge
state: Barcelona
Study officials:
References:
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.
citation: 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.
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.
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.