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

Surgery, Cardiac Clinical Trial

— ARVACC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03956264
• Other study ID #: 2019/01
• Status: Completed
• Phase: N/A
• Start date: September 26, 2019
• Est. completion date: July 24, 2020

Study information

• Verified date: August 2020
• Source: CMC Ambroise Paré
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: July 24, 2020
• Est. primary completion date: July 24, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety Disorders
• Surgery, Cardiac

Intervention

Device:
• Virtual Reality
Deepsen offers a VR platform that provides patients with immersive contents aimed to distract, inform, soften and improve the healthcare experience

Drug:
• Kalinox
Gas mixture composed of 50% Nitrous Oxide and 50% Oxygen

Locations

Country	Name	City	State
France	CMC Ambroise Paré	Neuilly-sur-Seine	Ile-de-France

Sponsors (1)

Lead Sponsor	Collaborator
CMC Ambroise Paré

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of patient comfort	Variation of the Analgesia / Nociception Index (ANI)	30 minutes
Secondary	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
Secondary	Level of anxiety during drain removal	Anxiety NRS ranging from 0 to 10 (0=no stress, 10=worst possible stress)	30 minutes
Secondary	Morphine consumption	Cumulated dose of oxynorm (mg)	1 hour
Secondary	Side effects due to Virtual Reality	Onset of vertigo, nausea or vomiting	2 hours
Secondary	Patient satisfaction	Satisfaction verbal rating scale (VRS) ranging from 0 to 4 (0=unsatisfied, 4=very satisfied)	2 hours
Secondary	Health staff satisfaction	Satisfaction VRS ranging from 0 to 4 (0=unsatisfied, 4=very satisfied)	30 minutes
Secondary	Side effects due to Kalinox	Onset of delirium, euphoria or headache	2 hours
Secondary	Correlation between ANI and Pain NRS		30 minutes
Secondary	Correlation between ANI and Anxiety NRS		30 minutes