Intraoperative Music Application and Postoperative Behaviour in Children and Adolescents.

Postoperative Behaviour Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02339298
• Other study ID #: Music study StV 10/09
• Status: Completed
• Phase: N/A
• First received: December 12, 2014
• Last updated: November 9, 2015
• Start date: July 2009
• Est. completion date: November 2015

Study information

• Verified date: November 2015
• Source: University Children's Hospital, Zurich
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Federal Office of Public Health
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: November 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 4 Years to 16 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Postoperative Behaviour

Intervention

Other:
• music application
music is applied during anaesthesia using headphones
• only headphones
music is not applied, only headphones are placed

Drug:
• a caudal block

Locations

Country	Name	City	State
Switzerland	University Children's Hospital	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
University Children's Hospital, Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	occurring of postoperative vomiting		baseline	No
Secondary	occurring of postoperative vomiting		15 min after arrival at the recovery room	No
Secondary	occurring of postoperative vomiting		before discharge to the ward, which means after an expected average stay of 2 hours at the recovery room	No
Secondary	rating of the behaviour of the child in the recovery room by parents using a questionnaire		baseline	No
Secondary	rating of the behaviour of the child in the recovery room by parents using a questionnaire		15 min after arrival at the recovery room	No
Secondary	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	No
Secondary	rating of the behaviour of the child in the recovery room by caretaking personnel using a questionnaire		baseline	No
Secondary	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	No
Secondary	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	No