Effect of Music on Emergence Delirium

December 16, 2016 updated by: DR. Michelle Olivier, University of Pretoria

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 7 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Music
Children will receive music via headphones
Other: Music
Children will be randomised to receive either music via headphones or silence via headphones
EXPERIMENTAL: No music
Children will listen to silence via headphones
Other: No music
Children will be randomised to receive either music via headphones or silence via headphones

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The effect of music on the prevalence of emergence delirium in paediatric patients
Time Frame: Up to 12 months
Up to 12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
The effect of music therapy on the severity of emergence delirium in paediatric patients.
Time Frame: Up to 12 months
Up to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pretoria

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2017

Primary Completion (ANTICIPATED)

June 1, 2017

Study Completion (ANTICIPATED)

July 1, 2017

Study Registration Dates

First Submitted

December 13, 2016

First Submitted That Met QC Criteria

December 16, 2016

First Posted (ESTIMATE)

December 21, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

December 21, 2016

Last Update Submitted That Met QC Criteria

December 16, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 451/2016

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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