NCT02339298

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2009

Completed
5.5 years until next milestone

First Submitted

Initial submission to the registry

December 12, 2014

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 15, 2015

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
Last Updated

November 10, 2015

Status Verified

November 1, 2015

Enrollment Period

6.3 years

First QC Date

December 12, 2014

Last Update Submit

November 9, 2015

Conditions

Postoperative Behaviour

Keywords

Music Therapy

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (9)

  • 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

  • +4 more secondary outcomes

Study Arms (2)

Music group

ACTIVE COMPARATOR

music application

Other: music applicationDrug: a caudal block

Control group

SHAM COMPARATOR

only headphones

Other: only headphonesDrug: a caudal block

Interventions

music applicationOTHER

music is applied during anaesthesia using headphones

Music group
only headphonesOTHER

music is not applied, only headphones are placed

Control group
a caudal blockDRUG
Control groupMusic group

Eligibility Criteria

Age4 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Children's Hospital

Zurich, Canton of Zurich, 8032, Switzerland

Location

Study Officials

  • Markus Weiss, Prof.

    University Children's Hospital, Zurich

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 12, 2014

First Posted

January 15, 2015

Study Start

July 1, 2009

Primary Completion

October 1, 2015

Study Completion

November 1, 2015

Last Updated

November 10, 2015

Record last verified: 2015-11

Locations

CH(1)