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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Music group | Active Comparator | music application |
|
| Control group | Sham Comparator | only headphones |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| music application | Other | music is applied during anaesthesia using headphones |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Occuring of a behaviour change | Patients are followed during the first 4 weeks after the operation by parents using a questionnaire in order to detect behaviour changes after the operation. | patients are followed during the first 4 weeks after the operation |
| Measure | Description | Time Frame |
|---|---|---|
| occurring of postoperative vomiting | baseline | |
| occurring of postoperative vomiting | 15 min after arrival at the recovery room | |
| occurring of postoperative vomiting |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Markus Weiss, Prof. | University Children's Hospital, Zurich | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Children's Hospital | Zurich | Canton of Zurich | 8032 | Switzerland |
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| only headphones |
| Other |
music is not applied, only headphones are placed |
|
| a caudal block | Drug |
|
| before discharge to the ward, which means after an expected average stay of 2 hours at the recovery room |
| rating of the behaviour of the child in the recovery room by parents using a questionnaire | baseline |
| rating of the behaviour of the child in the recovery room by parents using a questionnaire | 15 min after arrival at the recovery room |
| rating of the behaviour of the child in the recovery room by parents using a questionnaire | before discharge to the ward, which means after an expected average stay of 2 hours at the recovery room |
| rating of the behaviour of the child in the recovery room by caretaking personnel using a questionnaire | baseline |
| rating of the behaviour of the child in the recovery room by caretaking personnel using a questionnaire | 15 min after arrival at the recovery room |
| rating of the behaviour of the child in the recovery room by caretaking personnel using a questionnaire | before discharge to the ward, which means after an expected average stay of 2 hours at the recovery room |