Effects of Early Musical Intervention on Prevalence and Severity of Paroxysmal Sympathetic Hyperactivity After Severe Traumatic Brain Injury
NCT ID: NCT02783105
Last Updated: 2021-11-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
11 participants
INTERVENTIONAL
2016-11-20
2019-12-18
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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Musical intervention
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.
Musical intervention
Control
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
Control
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
Interventions
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Musical intervention
Control
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
Eligibility Criteria
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Inclusion Criteria
* National health service coverage
* Informed consent signed by next of kin
Exclusion Criteria
* Conditions interfering with measures: bilateral fixed pupils, temporal bone fracture including acoustic channel, eye trauma, previous eye surgery, otorrhagia, hypoacusis,
* Preexisting autonomic nervous system imbalance: severe diabetes, arrhythmias, pace maker, implantable defibrillator, cardiac transplantation
* Respiratory rate \< 9/min
* Patient subject to guardianship or wardship
* Pregnant or breastfeeding woman
* Current participation in another biomedical research protocol
18 Years
65 Years
ALL
No
Sponsors
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Fondation Apicil
OTHER
MDMS
UNKNOWN
Association française des traumatisés crâniens d'Alsace
UNKNOWN
Association strasbourgeoise des médecins et infirmiers en anesthésie réanimation
UNKNOWN
University Hospital, Strasbourg, France
OTHER
Responsible Party
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Locations
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Service d'Anesthésie Réanimation- Hôpital de Hautepierre
Strasbourg, , France
Countries
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Other Identifiers
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6224
Identifier Type: -
Identifier Source: org_study_id