Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Virtual Reality | Device | Deepsen offers a VR platform that provides patients with immersive contents aimed to distract, inform, soften and improve the healthcare experience |
|
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of patient comfort | Variation of the Analgesia / Nociception Index (ANI) | 30 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Level of pain during drain removal | Pain numerical rating scale (NRS) ranging from 0 to 10 (0=no pain, 10=worst possible pain) | 30 minutes |
| Level of anxiety during drain removal | Anxiety NRS ranging from 0 to 10 (0=no stress, 10=worst possible stress) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CMC Ambroise Paré | Neuilly-sur-Seine | Île-de-France Region | 92200 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33983498 | Result | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D010146 | Pain |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| C534042 | kalinox |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Kalinox | Drug | Gas mixture composed of 50% Nitrous Oxide and 50% Oxygen |
|
| 30 minutes |
| Morphine consumption | Cumulated dose of oxynorm (mg) | 1 hour |
| Side effects due to Virtual Reality | Onset of vertigo, nausea or vomiting | 2 hours |
| Patient satisfaction | Satisfaction verbal rating scale (VRS) ranging from 0 to 4 (0=unsatisfied, 4=very satisfied) | 2 hours |
| Health staff satisfaction | Satisfaction VRS ranging from 0 to 4 (0=unsatisfied, 4=very satisfied) | 30 minutes |
| Side effects due to Kalinox | Onset of delirium, euphoria or headache | 2 hours |
| Correlation between ANI and Pain NRS | 30 minutes |
| Correlation between ANI and Anxiety NRS | 30 minutes |