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inclusion difficulties
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| Name | Class |
|---|---|
| Fondation Apicil | OTHER |
| MDMS | UNKNOWN |
| Association française des traumatisés crâniens d'Alsace | UNKNOWN |
| Association strasbourgeoise des médecins et infirmiers en anesthésie réanimation |
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Paroxysmal sympathetic hyperactivity (PSH) is a frequent symptom after traumatic brain injury and concerns up to 30% of severely brain-injured patients.
PSH is due to unbalanced autonomic nervous system activity, resulting in sympathetic surges causing hypertension, tachycardia, sweating and hypertonia. The affected patients suffer more pain, more cardiovascular distress, more infections and prolonged rehabilitation and mechanical ventilation; additionally it could lead to a worse outcome.
Classical music was shown to reduce autonomic nervous system imbalance in healthy people and in many medical diseases. It could be a means to dampen sympathetic surges for brain-injured patients presenting with PSH, as well.
Our study aims at demonstrating that early musical intervention, started with the weaning of sedation, can reduce both the prevalence and the severity of paroxysmal sympathetic hyperactivity in traumatic brain-injured patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Musical intervention | Experimental | Music is provided through headphones: Two 30-min musical sessions per day (one in the morning and one in the evening) beginning at the onset of desedation (Day 0) until day 21. Both have inverted "U" shape. |
|
| Control | Sham Comparator | Patients wear headphones twice a day during 30 minutes, starting at the onset of desedation (Day 0) until day 21, but no music is provided (blank playlist): Sham |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Musical intervention | Other |
| ||
| Control |
| Measure | Description | Time Frame |
|---|---|---|
| Paroxysmal Sympathetic Hyperactivity Assessment Measure [PSH-AM] (ranging from 0 to 29) | The PSH-AM combines the sum of Clinical Features Scale [CFS] (from 0 to 18) and the Diagnostic Likelihood tool [DLT] (from 0 to 11) | from desedation (Day 0) to Day 21. |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the Clinical Features Scale curve | from Day 0 to Day 21. | |
| Mean Analgesia Nociception Index | from Day 0 to Day 21. | |
| Neurological Pupil Index |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Service d'Anesthésie Réanimation- Hôpital de Hautepierre | Strasbourg | 67098 | France |
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| UNKNOWN |
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Patients wear headphones twice a day during 30 minutes, starting at the onset of desedation (Day 0) until day 21, but no music is provided (blank playlist): Sham |
|
| from Day 0 to Day 21. |
| Pain (Critical-Care Pain Observation Tool) | from Day 0 to Day 21. |
| Neurological outcome (Wessex Head Injury Matrix) | from Day 0 to Day 21. |
| PSH-AM | Six and twelve months |
| Disability Rating Scale | Six and twelve months |
| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| ID | Term |
|---|---|
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
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