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

NCT ID: NCT03956264

Last Updated: 2021-03-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-26
• Study Completion Date: 2020-07-24

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.

Conditions

Surgery, Cardiac

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Virtual Reality

Intervention Type: DEVICE

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

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.

Group Type: ACTIVE_COMPARATOR

Kalinox

Intervention Type: DRUG

Gas mixture composed of 50% Nitrous Oxide and 50% Oxygen

Interventions

Virtual Reality

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

Intervention Type: DEVICE

Kalinox

Gas mixture composed of 50% Nitrous Oxide and 50% Oxygen

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CMC Ambroise Paré

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CMC Ambroise Paré

Neuilly-sur-Seine, Île-de-France Region, France

Countries

France

References

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.

Reference Type: DERIVED

PMID: 33983498 (View on PubMed)

Other Identifiers

2019/01

Identifier Type: -

Identifier Source: org_study_id