Interest of Virtual Reality in the Management of Anxiety and Pain Related to Post-cardiac Surgery Care
ARVACC
1 other identifier
interventional
200
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2019
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 16, 2019
CompletedFirst Posted
Study publicly available on registry
May 20, 2019
CompletedStudy Start
First participant enrolled
September 26, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 24, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
July 24, 2020
CompletedApril 8, 2026
April 1, 2026
10 months
May 16, 2019
April 2, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Assessment of patient comfort
Variation of the Analgesia / Nociception Index (ANI)
30 minutes
Secondary Outcomes (9)
Level of pain during drain removal
30 minutes
Level of anxiety during drain removal
30 minutes
Morphine consumption
1 hour
Side effects due to Virtual Reality
2 hours
Patient satisfaction
2 hours
- +4 more secondary outcomes
Study Arms (2)
VR
EXPERIMENTALVR 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.
Kalinox®
ACTIVE COMPARATORStart 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.
Interventions
Deepsen offers a VR platform that provides patients with immersive contents aimed to distract, inform, soften and improve the healthcare experience
Eligibility Criteria
You may qualify if:
- Extubated after cardiac surgery
- Sinus rhythm
- Consent for participation
- Affiliation to the social security system
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CMC Ambroise Paré
Neuilly-sur-Seine, Île-de-France Region, 92200, France
Related Publications (1)
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.
PMID: 33983498RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 16, 2019
First Posted
May 20, 2019
Study Start
September 26, 2019
Primary Completion
July 24, 2020
Study Completion
July 24, 2020
Last Updated
April 8, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share