Surgery, CardiacARVACCNCT03956264
Interest of Virtual Reality in the Management of Anxiety and Pain Related to Post-cardiac Surgery Care
A study testing Virtual Reality and Kalinox in people with Surgery, Cardiac, run by CMC Ambroise Paré at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgery, Cardiac
- What is being tested?
- Virtual Reality and Kalinox
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 26 Sep 2019to 24 Jul 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Extubated after cardiac surgery
- Sinus rhythm
- Consent for participation
- Affiliation to the social security system
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Being tested
- Virtual Reality, Kalinox
- Keywords
- Pain, Anxiety, Mediastinal drain removal
- Medical subject headings
- Pain, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual RealityDevice
Deepsen offers a VR platform that provides patients with immersive contents aimed to distract, inform, soften and improve the healthcare experience
KalinoxDrug
Gas mixture composed of 50% Nitrous Oxide and 50% Oxygen
| Study group | Role | What they receive |
|---|---|---|
| VR | Experimental | 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. Receives: Device: Virtual Reality |
| Kalinox® | Active comparator | 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. Receives: Drug: Kalinox |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of patient comfort
Variation of the Analgesia / Nociception Index (ANI)
Measured: 30 minutes
Secondary outcomes (9)
Level of pain during drain removal
Pain numerical rating scale (NRS) ranging from 0 to 10 (0=no pain, 10=worst possible pain)
Measured: 30 minutes
Level of anxiety during drain removal
Anxiety NRS ranging from 0 to 10 (0=no stress, 10=worst possible stress)
Measured: 30 minutes
Morphine consumption
Cumulated dose of oxynorm (mg)
Measured: 1 hour
Side effects due to Virtual Reality
Onset of vertigo, nausea or vomiting
Measured: 2 hours
Patient satisfaction
Satisfaction verbal rating scale (VRS) ranging from 0 to 4 (0=unsatisfied, 4=very satisfied)
Measured: 2 hours
Health staff satisfaction
Satisfaction VRS ranging from 0 to 4 (0=unsatisfied, 4=very satisfied)
Measured: 30 minutes
Side effects due to Kalinox
Onset of delirium, euphoria or headache
Measured: 2 hours
Correlation between ANI and Pain NRS
Measured: 30 minutes
Correlation between ANI and Anxiety NRS
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2019
- Study start26 Sep 2019
- Primary completion24 Jul 2020
- Study completion24 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Surgery, CardiacStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- CMC Ambroise Paré
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03956264
- Sponsor's protocol ID
- 2019/01
- Acronym
- ARVACC
- Status last verified
- Apr 2026
- First submitted
- 16 May 2019
- Last updated
- 8 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33983498
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interest of Virtual Reality in the Management of Anxiety and Pain Related to Post-cardiac Surgery Care
- ClinicalTrials.gov ID
- NCT03956264
- Acronym / sponsor ID
- ARVACC / 2019/01
- Conditions
- Surgery, Cardiac
- Keywords
- Pain, Anxiety, Mediastinal drain removal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- CMC Ambroise ParéUniversity, hospital or other
- Study start
- 26 Sep 2019 (actual)
- Primary completion
- 24 Jul 2020 (actual)
- Study completion
- 24 Jul 2020 (actual)
- First posted
- 20 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VR | Experimental | Device: Virtual RealityVR 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 comparator | Drug: KalinoxStart 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Extubated after cardiac surgery
- Sinus rhythm
- Consent for participation
- Affiliation to the social security system
Key exclusion criteria (7 listed)
- Pacemaker
- Visual acuity making impossible the use of virtual reality
- Intolerance to morphine
- Contraindication to Kalinox®
- Pregnant or breastfeeding women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual RealityDeepsen offers a VR platform that provides patients with immersive contents aimed to distract, inform, soften and improve the healthcare experience | Device | VR |
| KalinoxGas mixture composed of 50% Nitrous Oxide and 50% Oxygen | Drug | Kalinox® |
Primary outcome
Assessment of patient comfort
Time frame: 30 minutes
Variation of the Analgesia / Nociception Index (ANI)
9 secondary outcomes
Level of pain during drain removal
Time frame: 30 minutes
Level of anxiety during drain removal
Time frame: 30 minutes
Morphine consumption
Time frame: 1 hour
Side effects due to Virtual Reality
Time frame: 2 hours
Patient satisfaction
Time frame: 2 hours
Health staff satisfaction
Time frame: 30 minutes
Side effects due to Kalinox
Time frame: 2 hours
Correlation between ANI and Pain NRS
Time frame: 30 minutes
Correlation between ANI and Anxiety NRS
Time frame: 30 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2026.
- Results publication: PubMed 33983498Laghlam 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality and Kalinox in people with Surgery, Cardiac, run by CMC Ambroise Paré at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of patient comfort (time frame: 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03956264, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2026.