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

Primary Purpose

Pain, Anxiety

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
VR glasses
Control group
Sponsored by
Gemma Via Clavero
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Pain focused on measuring Virtual reality glasses

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital Universitari de Bellvitge

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Virtual reality

Control group

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Procedural pain score
Numerical rating scale (NRS). The pain can be scored from 0 to 10 (0=no pain, 10= worst possible pain)
Procedural pain score
Numerical rating scale (NRS). The pain can be scored from 0 to 10 (0=no pain, 10= worst possible pain)
Procedural pain score
Numerical rating scale (NRS). The pain can be scored from 0 to 10 (0=no pain, 10= worst possible pain)
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)
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)
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)

Secondary Outcome Measures

Sociodemographic and clinical factors
Age, gender, past medical history
Blood pressure
Systolic, Diastolic and mean blood pressure measure in mmHg
Blood pressure
Systolic, Diastolic and mean blood pressure measure in mmHg
Blood pressure
Number of systolic, diastolic and mean blood pressure measure in mmHg
Heart rate
Number in beats per minute
Heart rate
Number in beats per minute
Heart rate
Number in beats per minute
Respiratory rate
Number in breaths per minute
Respiratory rate
Number in breaths per minute
Respiratory rate
Number in breaths per minute
Type of cardiac surgery
Type
Type of chest drains
Mediastinal or pleural drains
Number of chest drains
Number
Dose of analgesic drugs
Cumulated dose of analgesia drugs
Patient satisfaction
Numerical Rating Scale (NRS). Patient's satisfaction will be scored from 0 to 4 (0= unsatisfied, 4=very satisfied).
Adverse events
Type of adverse events experienced by patients

Full Information

First Posted
April 4, 2022
Last Updated
March 25, 2023
Sponsor
Gemma Via Clavero
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1. Study Identification

Unique Protocol Identification Number
NCT05332119
Brief Title
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

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
April 1, 2021 (Actual)
Primary Completion Date
March 15, 2023 (Actual)
Study Completion Date
March 15, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Gemma Via Clavero

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Anxiety
Keywords
Virtual reality glasses

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Each patient will be randomized in a 1:1 ratio between the two arms of the study
Masking
None (Open Label)
Allocation
Randomized
Enrollment
98 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Virtual reality
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
Sham Comparator
Arm Description
Patients in the control group will be cared for with the usual care protocol.
Intervention Type
Device
Intervention Name(s)
VR glasses
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Control group
Intervention Description
Patients will not receive distraction during chest drain removal
Primary Outcome Measure Information:
Title
Procedural pain score
Description
Numerical rating scale (NRS). The pain can be scored from 0 to 10 (0=no pain, 10= worst possible pain)
Time Frame
Baseline
Title
Procedural pain score
Description
Numerical rating scale (NRS). The pain can be scored from 0 to 10 (0=no pain, 10= worst possible pain)
Time Frame
1 minute after the removal of chest drains
Title
Procedural pain score
Description
Numerical rating scale (NRS). The pain can be scored from 0 to 10 (0=no pain, 10= worst possible pain)
Time Frame
30 minutes after the removal of chest drains
Title
Procedural anxiety score
Description
State-Trait Anxiety Inventory (STAI scale)- trait state. The anxiety can be scored from 0 to 60 (0=no anxiety, 60=worst possible anxiety)
Time Frame
Baseline
Title
Procedural anxiety score
Description
State-Trait Anxiety Inventory (STAI scale)- trait state. The anxisety can be scored from 0 to 60 (0=no anxiety, 60=worst possible anxiety)
Time Frame
1 minute after the removal of chest drains
Title
Procedural anxiety score
Description
State-Trait Anxiety Inventory (STAI scale)- trait state. The anxisety can be scored from 0 to 60 (0=no anxiety, 60=worst possible anxiety)
Time Frame
30 minutes after the removal of chest drains
Secondary Outcome Measure Information:
Title
Sociodemographic and clinical factors
Description
Age, gender, past medical history
Time Frame
Baseline
Title
Blood pressure
Description
Systolic, Diastolic and mean blood pressure measure in mmHg
Time Frame
Baseline
Title
Blood pressure
Description
Systolic, Diastolic and mean blood pressure measure in mmHg
Time Frame
1 minute after the removal of chest drains
Title
Blood pressure
Description
Number of systolic, diastolic and mean blood pressure measure in mmHg
Time Frame
30 minutes after the removal of chest drains
Title
Heart rate
Description
Number in beats per minute
Time Frame
Baseline
Title
Heart rate
Description
Number in beats per minute
Time Frame
1minute after the removal of chest drains
Title
Heart rate
Description
Number in beats per minute
Time Frame
30 minutes after the removal of chest drains
Title
Respiratory rate
Description
Number in breaths per minute
Time Frame
Baseline
Title
Respiratory rate
Description
Number in breaths per minute
Time Frame
1 minute after the removal of chest drains
Title
Respiratory rate
Description
Number in breaths per minute
Time Frame
30 minutes after the removal of chest drains
Title
Type of cardiac surgery
Description
Type
Time Frame
Baseline
Title
Type of chest drains
Description
Mediastinal or pleural drains
Time Frame
At baseline
Title
Number of chest drains
Description
Number
Time Frame
At baseline
Title
Dose of analgesic drugs
Description
Cumulated dose of analgesia drugs
Time Frame
1 hour before the procedure
Title
Patient satisfaction
Description
Numerical Rating Scale (NRS). Patient's satisfaction will be scored from 0 to 4 (0= unsatisfied, 4=very satisfied).
Time Frame
30 minutes
Title
Adverse events
Description
Type of adverse events experienced by patients
Time Frame
30 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Hospital Universitari de Bellvitge
City
L'Hospitalet De Llobregat
State/Province
Barcelona
ZIP/Postal Code
08907
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
34163231
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.
Results Reference
background
PubMed Identifier
30113379
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.
Results Reference
background
PubMed Identifier
33347848
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.
Results Reference
background
PubMed Identifier
33415290
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.
Results Reference
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Virtual Reality During the Removal of Chest Drains in Critically-ill Patients

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