Anxiety, Pain
Conditions
Keywords
Virtual reality glasses
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)
Interventions
DEVICEVR 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.
OTHERControl group
Patients will not receive distraction during chest drain removal
Sponsors
Gemma Via Clavero
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
Each patient will be randomized in a 1:1 ratio between the two arms of the study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sociodemographic and clinical factors | Baseline | Age, gender, past medical history |
| Blood pressure | Baseline | Systolic, Diastolic and mean blood pressure measure in mmHg |
| Heart rate | Baseline | Number in beats per minute |
| Respiratory rate | Baseline | Number in breaths per minute |
| Type of chest drains | At baseline | Mediastinal or pleural drains |
| 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 |
| Type of cardiac surgery | Baseline | Type |
| Number of chest drains | At baseline | Number |
Countries
Spain
Outcome results
None listed