Effect of Music on Emergence Delirium

Not Applicable

• Conditions: Emergence Delirium
• Interventions: Other: Music; Other: No music

• Registration Number: NCT02999542
• Lead Sponsor: University of Pretoria

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.

Study Timeline

• Status Verified: 2016-12
• Study First Submitted: 2016-12-13
• Study First Submitted QC: 2016-12-16
• Last Update Submitted: 2016-12-16
• Study First Posted: 2016-12-21
• Last Update Posted: 2016-12-21
• Study Start: 2017-01
• Primary Completion: 2017-06
• Study Completion: 2017-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Music	Music	Children will receive music via headphones
No music	No music	Children will listen to silence via headphones

Primary Outcome Measures

Name	Time	Method
The effect of music on the prevalence of emergence delirium in paediatric patients	Up to 12 months

Secondary Outcome Measures

Name	Time	Method
The effect of music therapy on the severity of emergence delirium in paediatric patients.	Up to 12 months