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AzTrials

PainNCT05332119

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

A study testing VR glasses in people with Pain and Anxiety, run by Gemma Via Clavero at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pain, Anxiety
What is being tested?
VR glasses
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
98 participants
Where
1 siteSpain
Study dates
1 Apr 2021to 15 Mar 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Hospital Universitari de Bellvitge

    L'Hospitalet de Llobregat, Barcelona, 08907

Other trials in Spain

About this study

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

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.

Read the 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)

Conditions
Pain, Anxiety
Being tested
VR glasses, Control group
Keywords
Virtual reality glasses
Medical subject headings
Pain, Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VR glassesDevice

    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.

  • Control groupOther

    Patients will not receive distraction during chest drain removal

Study groups in NCT05332119
Study groupRoleWhat they receive
Virtual realityExperimentalThe 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.
Receives: Device: VR glasses
Control groupSham comparatorPatients in the control group will be cared for with the usual care protocol.
Receives: Other: Control group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Procedural pain score

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

    Measured: Baseline

  2. Procedural pain score

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

    Measured: 1 minute after the removal of chest drains

  3. Procedural pain score

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

    Measured: 30 minutes after the removal of chest drains

  4. 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)

    Measured: Baseline

  5. 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)

    Measured: 1 minute after the removal of chest drains

  6. 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)

    Measured: 30 minutes after the removal of chest drains

Secondary outcomes (16)

  1. Sociodemographic and clinical factors

    Age, gender, past medical history

    Measured: Baseline

  2. Blood pressure

    Systolic, Diastolic and mean blood pressure measure in mmHg

    Measured: Baseline

  3. Blood pressure

    Systolic, Diastolic and mean blood pressure measure in mmHg

    Measured: 1 minute after the removal of chest drains

  4. Blood pressure

    Number of systolic, diastolic and mean blood pressure measure in mmHg

    Measured: 30 minutes after the removal of chest drains

  5. Heart rate

    Number in beats per minute

    Measured: Baseline

  6. Heart rate

    Number in beats per minute

    Measured: 1minute after the removal of chest drains

  7. Heart rate

    Number in beats per minute

    Measured: 30 minutes after the removal of chest drains

  8. Respiratory rate

    Number in breaths per minute

    Measured: Baseline

  9. Respiratory rate

    Number in breaths per minute

    Measured: 1 minute after the removal of chest drains

  10. Respiratory rate

    Number in breaths per minute

    Measured: 30 minutes after the removal of chest drains

  11. Type of cardiac surgery

    Type

    Measured: Baseline

  12. Type of chest drains

    Mediastinal or pleural drains

    Measured: At baseline

  13. Number of chest drains

    Number

    Measured: At baseline

  14. Dose of analgesic drugs

    Cumulated dose of analgesia drugs

    Measured: 1 hour before the procedure

  15. Patient satisfaction

    Numerical Rating Scale (NRS). Patient's satisfaction will be scored from 0 to 4 (0= unsatisfied, 4=very satisfied).

    Measured: 30 minutes

  16. Adverse events

    Type of adverse events experienced by patients

    Measured: 30 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Apr 2022
  2. Study start1 Apr 2021
  3. Primary completion15 Mar 2023
  4. Study completion15 Mar 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
Each patient will be randomized in a 1:1 ratio between the two arms of the study
Masking
None (open label)
Enrolment
98 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05332119
Sponsor's protocol ID
ICPS001/22
Status last verified
Mar 2023
First submitted
4 Apr 2022
Last updated
28 Mar 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 34163231

  • 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.

    PubMed 30113379

  • 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.

    PubMed 33347848

  • 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.

    PubMed 33415290

Questions about this trial

What is this clinical trial studying?

A study testing VR glasses in people with Pain and Anxiety, run by Gemma Via Clavero at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Procedural pain score (time frame: Baseline). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05332119, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2023.

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