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

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.

Study Overview

• Status: Completed
• Conditions: Surgery, Cardiac
• Intervention / Treatment: Device: Virtual Reality; Drug: Kalinox

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 Type: Interventional
• Enrollment (Actual): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Ile-de-France
    • Neuilly-sur-Seine, Ile-de-France, France, 92200
      • CMC Ambroise Paré

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: VR; 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.	Device: Virtual Reality; Deepsen offers a VR platform that provides patients with immersive contents aimed to distract, inform, soften and improve the healthcare experience
Active Comparator: 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.	Drug: Kalinox; Gas mixture composed of 50% Nitrous Oxide and 50% Oxygen

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of patient comfort	Variation of the Analgesia / Nociception Index (ANI)	30 minutes

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: CMC Ambroise Paré

Publications and helpful links

General Publications

• Laghlam D, Naudin C, Coroyer L, Aidan V, Malvy J, Rahoual G, Estagnasie P, Squara P. Virtual reality vs. Kalinox(R) for management of pain in intensive care unit after cardiac surgery: a randomized study. Ann Intensive Care. 2021 May 13;11(1):74. doi: 10.1186/s13613-021-00866-w.

Study record dates

Study Major Dates

• Study Start (Actual): September 26, 2019
• Primary Completion (Actual): July 24, 2020
• Study Completion (Actual): July 24, 2020

Study Registration Dates

• First Submitted: May 16, 2019
• First Submitted That Met QC Criteria: May 16, 2019
• First Posted (Actual): May 20, 2019

Study Record Updates

• Last Update Posted (Actual): March 5, 2021
• Last Update Submitted That Met QC Criteria: March 3, 2021
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: Pain; Anxiety; Mediastinal drain removal
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: 2019/01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No