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Interest of Virtual Reality in the Management of Anxiety and Pain Related to Post-cardiac Surgery Care (ARVACC)
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Surgery, Cardiac | Device: Virtual Reality Drug: Kalinox | Not Applicable |
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 Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 200 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Other |
| Official Title: | Interest of Virtual Reality in the Management of Anxiety and Pain Related to Post-cardiac Surgery Care |
| Actual Study Start Date : | September 26, 2019 |
| Actual Primary Completion Date : | July 24, 2020 |
| Actual Study Completion Date : | July 24, 2020 |
| Arm | Intervention/treatment |
|---|---|
|
Experimental: 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. |
Device: Virtual Reality
Deepsen offers a VR platform that provides patients with immersive contents aimed to distract, inform, soften and improve the healthcare experience
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Active Comparator: 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. |
Drug: Kalinox
Gas mixture composed of 50% Nitrous Oxide and 50% Oxygen
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- Assessment of patient comfort [ Time Frame: 30 minutes ]Variation of the Analgesia / Nociception Index (ANI)
- 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)
- Level of anxiety during drain removal [ Time Frame: 30 minutes ]Anxiety NRS ranging from 0 to 10 (0=no stress, 10=worst possible stress)
- Morphine consumption [ Time Frame: 1 hour ]Cumulated dose of oxynorm (mg)
- Side effects due to Virtual Reality [ Time Frame: 2 hours ]Onset of vertigo, nausea or vomiting
- Patient satisfaction [ Time Frame: 2 hours ]Satisfaction verbal rating scale (VRS) ranging from 0 to 4 (0=unsatisfied, 4=very satisfied)
- Health staff satisfaction [ Time Frame: 30 minutes ]Satisfaction VRS ranging from 0 to 4 (0=unsatisfied, 4=very satisfied)
- Side effects due to Kalinox [ Time Frame: 2 hours ]Onset of delirium, euphoria or headache
- Correlation between ANI and Pain NRS [ Time Frame: 30 minutes ]
- Correlation between ANI and Anxiety NRS [ Time Frame: 30 minutes ]
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
| France | |
| CMC Ambroise Paré | |
| Neuilly-sur-Seine, Ile-de-France, France, 92200 | |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date ICMJE | May 16, 2019 | ||||
| First Posted Date ICMJE | May 20, 2019 | ||||
| Last Update Posted Date | March 5, 2021 | ||||
| Actual Study Start Date ICMJE | September 26, 2019 | ||||
| Actual Primary Completion Date | July 24, 2020 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Assessment of patient comfort [ Time Frame: 30 minutes ] Variation of the Analgesia / Nociception Index (ANI)
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | |||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Interest of Virtual Reality in the Management of Anxiety and Pain Related to Post-cardiac Surgery Care | ||||
| Official Title ICMJE | Interest of Virtual Reality in the Management of Anxiety and Pain Related to Post-cardiac Surgery Care | ||||
| 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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase ICMJE | Not Applicable | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Other |
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| Condition ICMJE | Surgery, Cardiac | ||||
| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * | Laghlam D, Naudin C, Coroyer L, Aidan V, Malvy J, Rahoual G, Estagnasié P, Squara P. Virtual reality vs. Kalinox® 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. | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Actual Enrollment ICMJE |
200 | ||||
| Original Estimated Enrollment ICMJE | Same as current | ||||
| Actual Study Completion Date ICMJE | July 24, 2020 | ||||
| Actual Primary Completion Date | July 24, 2020 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers ICMJE | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries ICMJE | France | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT03956264 | ||||
| Other Study ID Numbers ICMJE | 2019/01 | ||||
| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | CMC Ambroise Paré | ||||
| Study Sponsor ICMJE | CMC Ambroise Paré | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE | Not Provided | ||||
| PRS Account | CMC Ambroise Paré | ||||
| Verification Date | August 2020 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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