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Clinical Trials/NCT05332119
NCT05332119
Completed
Not Applicable

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

Gemma Via Clavero1 site in 1 country98 target enrollmentApril 1, 2021
ConditionsPainAnxiety

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pain
Sponsor
Gemma Via Clavero
Enrollment
98
Locations
1
Primary Endpoint
Procedural pain score
Status
Completed
Last Updated
3 years ago

Overview

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)

Registry
clinicaltrials.gov
Start Date
April 1, 2021
End Date
March 15, 2023
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Gemma Via Clavero
Responsible Party
Sponsor Investigator
Principal Investigator

Gemma Via Clavero

PhD. Advanced Practice Critical Care Nurse

Hospital Universitari de Bellvitge

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

Outcomes

Primary Outcomes

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)

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

  • Dose of analgesic drugs(1 hour before the procedure)
  • Blood pressure(30 minutes after the removal of chest drains)
  • Sociodemographic and clinical factors(Baseline)
  • Respiratory rate(30 minutes after the removal of chest drains)
  • Type of chest drains(At baseline)
  • Number of chest drains(At baseline)
  • Adverse events(30 minutes)
  • Heart rate(30 minutes after the removal of chest drains)
  • Type of cardiac surgery(Baseline)
  • Patient satisfaction(30 minutes)

Study Sites (1)

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