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Completed

NCT Number: NCT02339298

Intraoperative Music Application and 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.

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Key information

Conditions

Postoperative Behaviour

Age range

4 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Children's Hospital

Zurich, Canton of Zurich, 8032, Switzerland

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

music application

Other

music is applied during anaesthesia using headphones

only headphones

Other

music is not applied, only headphones are placed

a caudal block

Drug

Primary outcomes

  1. Occuring of a behaviour change

    Time frame: 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 outcomes

  1. occurring of postoperative vomiting

    Time frame: baseline

  2. occurring of postoperative vomiting

    Time frame: 15 min after arrival at the recovery room

  3. occurring of postoperative vomiting

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

  4. rating of the behaviour of the child in the recovery room by parents using a questionnaire

    Time frame: baseline

  5. rating of the behaviour of the child in the recovery room by parents using a questionnaire

    Time frame: 15 min after arrival at the recovery room

  6. rating of the behaviour of the child in the recovery room by parents using a questionnaire

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

  7. rating of the behaviour of the child in the recovery room by caretaking personnel using a questionnaire

    Time frame: baseline

  8. rating of the behaviour of the child in the recovery room by caretaking personnel using a questionnaire

    Time frame: 15 min after arrival at the recovery room

  9. rating of the behaviour of the child in the recovery room by caretaking personnel using a questionnaire

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

Sponsors and collaborators

Lead sponsor

University Children's Hospital, Zurich

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2015
Study completion
2015
First posted
Jan 15, 2015
Registry last updated
Nov 10, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.