Intraoperative Music Application and Postoperative Behaviour in Children and Adolescents.

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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Impact of Intraoperative Music Application on Postoperative Behaviour in Children and Adolescents.

Conditions
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Postoperative Behaviour

Intervention / Treatment
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* Other: music application
* Other: only headphones
* Drug: a caudal block


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Music group<br>music application | Other: music application<br>* music is applied during anaesthesia using headphones<br>Drug: a caudal block<br> <br> |
| Sham Comparator: Control group<br>only headphones | Other: only headphones<br>* music is not applied, only headphones are placed<br>Drug: a caudal block<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 |  | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Music Therapy