Skip to main content
OpenTrials
Completed

NCT Number: NCT03956264

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CMC Ambroise Paré

Neuilly-sur-Seine, Île-de-France Region, 92200, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Virtual reality

Device

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

Kalinox

Drug

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

Primary outcomes

  1. Assessment of patient comfort

    Time frame: 30 minutes

    Variation of the Analgesia / Nociception Index (ANI)

Secondary outcomes

  1. Level of pain during drain removal

    Time frame: 30 minutes

    Pain numerical rating scale (NRS) ranging from 0 to 10 (0=no pain, 10=worst possible pain)

  2. Level of anxiety during drain removal

    Time frame: 30 minutes

    Anxiety NRS ranging from 0 to 10 (0=no stress, 10=worst possible stress)

  3. Morphine consumption

    Time frame: 1 hour

    Cumulated dose of oxynorm (mg)

  4. Side effects due to Virtual Reality

    Time frame: 2 hours

    Onset of vertigo, nausea or vomiting

  5. Patient satisfaction

    Time frame: 2 hours

    Satisfaction verbal rating scale (VRS) ranging from 0 to 4 (0=unsatisfied, 4=very satisfied)

  6. Health staff satisfaction

    Time frame: 30 minutes

    Satisfaction VRS ranging from 0 to 4 (0=unsatisfied, 4=very satisfied)

  7. Side effects due to Kalinox

    Time frame: 2 hours

    Onset of delirium, euphoria or headache

  8. Correlation between ANI and Pain NRS

    Time frame: 30 minutes

  9. Correlation between ANI and Anxiety NRS

    Time frame: 30 minutes

Sponsors and collaborators

Lead sponsor

CMC Ambroise Paré

Other

Registry information

Acronym: ARVACC

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
May 20, 2019
Registry last updated
Apr 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.