Effect of Music on Emergence Delirium

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Emergence Delirium

Intervention / Treatment
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* Other: Music
* Other: No music


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 7 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Music<br>Children will receive music via headphones | Other: Music<br>* Children will be randomised to receive either music via headphones or silence via headphones<br>|
| Experimental: No music<br>Children will listen to silence via headphones | Other: No music<br>* Children will be randomised to receive either music via headphones or silence via headphones<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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