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OpenTrials
Completed

NCT Number: NCT05332119

Virtual Reality 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.

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Key information

Conditions

Pain Anxiety Anxiety Disorders Mental Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Universitari de Bellvitge

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Control Group

Other

Patients will not receive distraction during chest drain removal

Primary outcomes

  1. Procedural pain score

    Time frame: Baseline

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

  2. Procedural pain score

    Time frame: 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)

  3. Procedural pain score

    Time frame: 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)

  4. Procedural anxiety score

    Time frame: 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)

  5. Procedural anxiety score

    Time frame: 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)

  6. Procedural anxiety score

    Time frame: 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 outcomes

  1. Sociodemographic and clinical factors

    Time frame: Baseline

    Age, gender, past medical history

  2. Blood pressure

    Time frame: Baseline

    Systolic, Diastolic and mean blood pressure measure in mmHg

  3. Blood pressure

    Time frame: 1 minute after the removal of chest drains

    Systolic, Diastolic and mean blood pressure measure in mmHg

  4. Blood pressure

    Time frame: 30 minutes after the removal of chest drains

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

  5. Heart rate

    Time frame: Baseline

    Number in beats per minute

  6. Heart rate

    Time frame: 1minute after the removal of chest drains

    Number in beats per minute

  7. Heart rate

    Time frame: 30 minutes after the removal of chest drains

    Number in beats per minute

  8. Respiratory rate

    Time frame: Baseline

    Number in breaths per minute

  9. Respiratory rate

    Time frame: 1 minute after the removal of chest drains

    Number in breaths per minute

  10. Respiratory rate

    Time frame: 30 minutes after the removal of chest drains

    Number in breaths per minute

  11. Type of cardiac surgery

    Time frame: Baseline

    Type

  12. Type of chest drains

    Time frame: At baseline

    Mediastinal or pleural drains

  13. Number of chest drains

    Time frame: At baseline

    Number

  14. Dose of analgesic drugs

    Time frame: 1 hour before the procedure

    Cumulated dose of analgesia drugs

  15. Patient satisfaction

    Time frame: 30 minutes

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

  16. Adverse events

    Time frame: 30 minutes

    Type of adverse events experienced by patients

Sponsors and collaborators

Lead sponsor

Gemma Via Clavero

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Apr 18, 2022
Registry last updated
Mar 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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