Postoperative Behaviour Clinical Trial
Official title:
Impact of Intraoperative Music Application on Postoperative Behaviour in Children and Adolescents.
The purpose of the study is to evaluate whether intraoperative music application has a positive impact on postoperative behavior in children and adolescents.
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
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment