Clinical trial NCT03956264: Interest of Virtual Reality in the Management of Anxiety and Pain Related to Post-cardiac Surgery Care
Official title: Interest of Virtual Reality in the Management of Anxiety and Pain Related to Post-cardiac Surgery Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Surgery, Cardiac
Keywords: Pain
Anxiety
Mediastinal drain removal
Lead sponsor: CMC Ambroise Paré
Sponsor class: OTHER
First posted: 2019-05-20
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Assessment of patient comfort
timeFrame: 30 minutes
Secondary outcomes:
measure: Level of pain during drain removal
timeFrame: 30 minutes
measure: Level of anxiety during drain removal
timeFrame: 30 minutes
measure: Morphine consumption
timeFrame: 1 hour
measure: Side effects due to Virtual Reality
timeFrame: 2 hours
measure: Patient satisfaction
timeFrame: 2 hours
measure: Health staff satisfaction
timeFrame: 30 minutes
measure: Side effects due to Kalinox
timeFrame: 2 hours
measure: Correlation between ANI and Pain NRS
timeFrame: 30 minutes
measure: Correlation between ANI and Anxiety NRS
timeFrame: 30 minutes
Other outcomes:
Locations:
city: Neuilly-sur-Seine
country: France
facility: CMC Ambroise Paré
state: Ile-de-France
Study officials:
References:
citation: 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.