Interest of Virtual Reality in the Management of Anxiety and Pain Related to Post-cardiac Surgery Care

Not Applicable

Completed

• Conditions: Surgery, Cardiac
• Interventions: Drug: Kalinox; Device: Virtual Reality

• Registration Number: NCT03956264
• Lead Sponsor: CMC Ambroise Paré

Brief Summary

This study compares Virtual Reality versus Nitrous oxide administration for the management of anxiety and pain related to post-cardiac surgery care, especially during removal of mediastinal drainage.

Detailed Description

After cardiac surgery, the mediastinal and pleural drains are usually removed the second postoperative day, in the absence of complications. This procedure, realized by nurses, is a source of anxiety and pain for patients.

Nitrous oxide (Kalinox®) is commonly used to manage many situations of anxiety, including the removal of mediastinal and/or pleural drains, and has shown a greater effect than placebo in this indication.

Virtual Reality (VR) is a recent technology that allows the representation of a pleasant environment in three dimensions with a complete immersion by a helmet. By distracting patients, this technology can reduce anxiety, discomfort and ultimately pain associated with care.

This randomized monocentric trial compares VR versus Kalinox® administration for the management of anxiety and pain related to post-cardiac surgery care, especially mediastinal and/or pleural drain removal.

Study Timeline

• Study First Submitted: 2019-05-16
• Study First Submitted QC: 2019-05-16
• Study First Posted: 2019-05-20
• Study Start: 2019-09-26
• Primary Completion: 2020-07-24
• Study Completion: 2020-07-24
• Status Verified: 2020-08
• Last Update Submitted: 2021-03-03
• Last Update Posted: 2021-03-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Extubated after cardiac surgery
• Sinus rhythm
• Consent for participation
• Affiliation to the social security system

Exclusion Criteria

• Pacemaker
• Visual acuity making impossible the use of virtual reality
• Intolerance to morphine
• Contraindication to Kalinox®
• Pregnant or breastfeeding women
• Patients under protection of the adults (guardianship, curators or safeguard of justice)
• Communication difficulties or neuropsychiatric disorder

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Kalinox®	Kalinox	Start of Kalinox® administration by inhalation with a facial mask 1 min before the drain removal and stop after the procedure according to the usual procedure of the service. If Pain NRS \> 4, administration of morphine.
VR	Virtual Reality	VR Installation 5 min before the drain removal and stop 10 min after the procedure. If Pain assessed by numerical rating scale (NRS) \> 4, administration of morphine.

Primary Outcome Measures

Name	Time	Method
Assessment of patient comfort	30 minutes	Variation of the Analgesia / Nociception Index (ANI)

Secondary Outcome Measures

Name	Time	Method
Correlation between ANI and Anxiety NRS	30 minutes
Level of anxiety during drain removal	30 minutes	Anxiety NRS ranging from 0 to 10 (0=no stress, 10=worst possible stress)
Morphine consumption	1 hour	Cumulated dose of oxynorm (mg)
Health staff satisfaction	30 minutes	Satisfaction VRS ranging from 0 to 4 (0=unsatisfied, 4=very satisfied)
Side effects due to Kalinox	2 hours	Onset of delirium, euphoria or headache
Correlation between ANI and Pain NRS	30 minutes
Level of pain during drain removal	30 minutes	Pain numerical rating scale (NRS) ranging from 0 to 10 (0=no pain, 10=worst possible pain)
Side effects due to Virtual Reality	2 hours	Onset of vertigo, nausea or vomiting
Patient satisfaction	2 hours	Satisfaction verbal rating scale (VRS) ranging from 0 to 4 (0=unsatisfied, 4=very satisfied)

Trial Locations

Locations (1)

CMC Ambroise Paré; 🇫🇷 Neuilly-sur-Seine, Ile-de-France, France