Clinical trial NCT02339298: Intraoperative Music Application and Postoperative Behaviour in Children and Adolescents.
Official title: Impact of Intraoperative Music Application on Postoperative Behaviour in Children and Adolescents.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Behaviour
Keywords: Music Therapy
Lead sponsor: University Children's Hospital, Zurich
Sponsor class: OTHER
First posted: 2015-01-15
Enrollment: 140
Sex: ALL
Minimum age (years): 4
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to evaluate whether intraoperative music application has a positive impact on postoperative behavior in children and adolescents.

Detailed 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

Eligibility criteria: 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

Primary outcomes:
measure: Occuring of a behaviour change
timeFrame: patients are followed during the first 4 weeks after the operation
Secondary outcomes:
measure: occurring of postoperative vomiting
timeFrame: baseline
measure: occurring of postoperative vomiting
timeFrame: 15 min after arrival at the recovery room
measure: occurring of postoperative vomiting
timeFrame: before discharge to the ward, which means after an expected average stay of 2 hours at the recovery room
measure: rating of the behaviour of the child in the recovery room by parents using a questionnaire
timeFrame: baseline
measure: rating of the behaviour of the child in the recovery room by parents using a questionnaire
timeFrame: 15 min after arrival at the recovery room
measure: rating of the behaviour of the child in the recovery room by parents using a questionnaire
timeFrame: before discharge to the ward, which means after an expected average stay of 2 hours at the recovery room
measure: rating of the behaviour of the child in the recovery room by caretaking personnel using a questionnaire
timeFrame: baseline
measure: rating of the behaviour of the child in the recovery room by caretaking personnel using a questionnaire
timeFrame: 15 min after arrival at the recovery room
measure: rating of the behaviour of the child in the recovery room by caretaking personnel using a questionnaire
timeFrame: before discharge to the ward, which means after an expected average stay of 2 hours at the recovery room
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Children's Hospital
Study officials:
affiliation: University Children's Hospital, Zurich
name: Markus Weiss, Prof.
role: PRINCIPAL_INVESTIGATOR
References: