Intraoperative Music Application and Postoperative Behaviour in Children and Adolescents.
NCT ID: NCT02339298
Last Updated: 2015-11-10
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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COMPLETED
NA
140 participants
INTERVENTIONAL
2009-07-31
2015-11-30
Brief Summary
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Detailed Description
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Postoperative behaviour is evaluated by parents and by caretaking personnel in the recovery room at arrival, after 15 minutes and before discharge to the ward and at home by parents after one, two and four weeks using questionnaires.
sample size calculation: n = minimal number of required probands π = 70% (proportion of interest) → 0.7 π0 = 50% (null hypothesis proportion) → 0.5 μ = (100% - 90%power) → 1.28 v = 1.96 (level of significance p=0.05)
n \> \[ μ√ π(1- π) + v√ π0(1- π0)\]2 / (π - π0) n \> 61.4 + correction for drop-outs (+10%) n = 70 per group → 140 probands in total
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Music group
music application
music application
music is applied during anaesthesia using headphones
a caudal block
Control group
only headphones
only headphones
music is not applied, only headphones are placed
a caudal block
Interventions
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music application
music is applied during anaesthesia using headphones
only headphones
music is not applied, only headphones are placed
a caudal block
Eligibility Criteria
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Inclusion Criteria
* American Society of Anesthesiologists (ASA) physical status of 1 and 2
* elective inguinal herniotomy or circumcision
* general anaesthesia with sevoflurane and caudal block
* written informed consent available
Exclusion Criteria
* ASA physical status of 3 or higher
* emergency surgery
* no general anaesthesia with sevoflurane or/and caudal block
* no written informed consent available
4 Years
16 Years
ALL
No
Sponsors
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University Children's Hospital, Zurich
OTHER
Responsible Party
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Principal Investigators
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Markus Weiss, Prof.
Role: PRINCIPAL_INVESTIGATOR
University Children's Hospital, Zurich
Locations
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University Children's Hospital
Zurich, Canton of Zurich, Switzerland
Countries
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Other Identifiers
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Music study StV 10/09
Identifier Type: -
Identifier Source: org_study_id
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