Intraoperative Music Application and Postoperative Behaviour in Children and Adolescents.

Not Applicable

Completed

• Conditions: Postoperative Behaviour
• Interventions: Other: music application; Other: only headphones; Drug: a caudal block

• Registration Number: NCT02339298
• Lead Sponsor: University Children's Hospital, Zurich

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

Study Timeline

• Study Start: 2009-07
• Study First Submitted: 2014-12-12
• Study First Submitted QC: 2015-01-14
• Study First Posted: 2015-01-15
• Primary Completion: 2015-10
• Status Verified: 2015-11
• Study Completion: 2015-11
• Last Update Submitted: 2015-11-09
• Last Update Posted: 2015-11-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 140

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Music group	music application	music application
Music group	a caudal block	music application
Control group	a caudal block	only headphones
Control group	only headphones	only headphones

Primary Outcome Measures

Name	Time	Method
Occuring of a behaviour change	patients are followed during the first 4 weeks after the operation	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.

Secondary Outcome Measures

Name	Time	Method
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	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	before discharge to the ward, which means after an expected average stay of 2 hours at the recovery room

Trial Locations

Locations (1)

University Children's Hospital; 🇨🇭 Zurich, Switzerland