Intraoperative Music Application and Postoperative Behaviour in Children and Adolescents.
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About
The purpose of the study is to evaluate whether intraoperative music application has a positive impact on postoperative behavior in children and adolescents.
Full description
After induction of anesthesia, paralyzation of the patient and subsequent intubation, a caudal block is applied. After positioning of the patient, headphones are placed on the patients head and in case of the interventional group, music is played. Previously, the volume of the music is adjusted to a range from 50 to 60 decibel. Headphones are removed before extubation.
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
Enrollment
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Ages
Volunteers
Inclusion criteria
- age: 4-16 years
- 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
- age <4 or >16.99 years
- ASA physical status of 3 or higher
- emergency surgery
- no general anaesthesia with sevoflurane or/and caudal block
- no written informed consent available
Trial design
Primary purpose
Allocation
Interventional model
Masking
140 participants in 2 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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