Virtual Reality During the Removal of Chest Drains in Critically-ill Patients
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 Design
Arms and Interventions
| 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
|
Outcome Measures
Primary Outcome Measures
- Procedural pain score [Baseline]
Numerical rating scale (NRS). The pain can be scored from 0 to 10 (0=no pain, 10= worst possible pain)
- Procedural pain score [1 minute 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 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 [Baseline]
State-Trait Anxiety Inventory (STAI scale)- trait state. The anxiety can be scored from 0 to 60 (0=no anxiety, 60=worst possible anxiety)
- Procedural anxiety score [1 minute 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)
- 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
- Sociodemographic and clinical factors [Baseline]
Age, gender, past medical history
- Blood pressure [Baseline]
Systolic, Diastolic and mean blood pressure measure in mmHg
- Blood pressure [1 minute after the removal of chest drains]
Systolic, Diastolic and mean blood pressure measure in mmHg
- Blood pressure [30 minutes after the removal of chest drains]
Number of systolic, diastolic and mean blood pressure measure in mmHg
- Heart rate [Baseline]
Number in beats per minute
- Heart rate [1minute after the removal of chest drains]
Number in beats per minute
- Heart rate [30 minutes after the removal of chest drains]
Number in beats per minute
- Respiratory rate [Baseline]
Number in breaths per minute
- Respiratory rate [1 minute after the removal of chest drains]
Number in breaths per minute
- Respiratory rate [30 minutes after the removal of chest drains]
Number in breaths per minute
- Type of cardiac surgery [Baseline]
Type
- Type of chest drains [At baseline]
Mediastinal or pleural drains
- Number of chest drains [At baseline]
Number
- Dose of analgesic drugs [1 hour before the procedure]
Cumulated dose of analgesia drugs
- Patient satisfaction [30 minutes]
Numerical Rating Scale (NRS). Patient's satisfaction will be scored from 0 to 4 (0= unsatisfied, 4=very satisfied).
- Adverse events [30 minutes]
Type of adverse events experienced by patients
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Patients ≥ 18 years old
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Patients with Richmond Agitation-Sedation Scale (RASS) between -1 to RASS +1
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Patients undergoing cardiac surgery
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Patients with chest drains
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Patients who voluntarily agree to participate (informed consent form)
Exclusion Criteria:
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Patients with a language barrier
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Patients with cognitive impairments
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Patients with neuromuscular blockers
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Patients with a previous history of documented anxiety
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Patients with epilepsy
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Hemodynamically unstable patients
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Face or ocular infections, with could contaminate VR glasses
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hospital Universitari de Bellvitge | L'Hospitalet De Llobregat | Barcelona | Spain | 08907 |
Sponsors and Collaborators
- Gemma Via Clavero
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
- Devlin JW, Skrobik Y, Gélinas 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. Review.
- 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. Review.
- 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. Review.
- ICPS001/22