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Clinical Trials/NCT02999542
NCT02999542
Unknown
N/A

The Effect of Intraoperative Music on the Prevalence and Severity of Emergence Delirium in Paediatric Patients: A Randomised Controlled Trial

University of Pretoria0 sites40 target enrollmentJanuary 2017

Overview

Phase
N/A
Intervention
Not specified
Conditions
Emergence Delirium
Sponsor
University of Pretoria
Enrollment
40
Primary Endpoint
The effect of music on the prevalence of emergence delirium in paediatric patients
Last Updated
9 years ago

Overview

Brief Summary

The researchers are conducting a research study to see whether listening to music during an operation will have a positive effect on the way that children wake up from surgery/anaesthetic. It is a common phenomenon where children wake up unhappy, irritated and screaming (known as emergence delirium). Research have shown that music decreases anxiety and pain. The researchers want to see whether music can also influence a child's behaviour after emerging from anaesthesia. In other words whether they will be more calm and cooperative after listening to music while they are asleep during surgery. Should music have a positive effect, anaesthesiologists may use it in future to improve care of patients coming for surgery.

Detailed Description

Children coming for certain elective surgeries, where pain has been excluded as a confounding factor, will have headphones placed on their ears after induction of anaesthesia. They will be randomised to two groups, one will receive music and the other just silence. The headphones will be removed just before waking the patient up. In the recovery room the child's behaviour will be observed and will be scored according to a validated score. The two groups will then be compared to see whether music makes a difference to the behaviour after anaesthesia.

Registry
clinicaltrials.gov
Start Date
January 2017
End Date
July 2017
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

DR. Michelle Olivier

DR

University of Pretoria

Eligibility Criteria

Inclusion Criteria

  • Ages 2-7 years
  • American society of anaesthesiologists class I and II patients
  • Child has adequate hearing
  • Surgery or procedure under general anaesthesia
  • Receiving standardised anaesthetic
  • Type of surgeries included: orthopaedic, urological, paediatric surgery and ophthalmology
  • Minimum exposure to music must be 15minutes
  • Child may not receive any premedication

Exclusion Criteria

  • American society of Anaesthesiologists class 3 and above
  • Emergency cases
  • Children with hearing problems
  • Cognitive impairment

Outcomes

Primary Outcomes

The effect of music on the prevalence of emergence delirium in paediatric patients

Time Frame: Up to 12 months

Secondary Outcomes

  • The effect of music therapy on the severity of emergence delirium in paediatric patients.(Up to 12 months)

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