Intraoperative Music Application and Postoperative Behaviour in Children and Adolescents.

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Behaviour
• Intervention / Treatment: Other: music application; Drug: a caudal block; Other: only headphones

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 Type: Interventional
• Enrollment (Actual): 140
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Zurich, Switzerland, 8032
    • University Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 16 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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	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

Collaborators and Investigators

• Sponsor: University Children's Hospital, Zurich
• Investigators: Principal Investigator: Markus Weiss, Prof., University Children's Hospital, Zurich

Study record dates

Study Major Dates

• Study Start: July 1, 2009
• Primary Completion (Actual): October 1, 2015
• Study Completion (Actual): November 1, 2015

Study Registration Dates

• First Submitted: December 12, 2014
• First Submitted That Met QC Criteria: January 14, 2015
• First Posted (Estimate): January 15, 2015

Study Record Updates

• Last Update Posted (Estimate): November 10, 2015
• Last Update Submitted That Met QC Criteria: November 9, 2015
• Last Verified: November 1, 2015

More Information

Terms related to this study

• Keywords: Music Therapy
• Other Study ID Numbers: Music study StV 10/09