Effect of Music on Emergence Delirium

Emergence Delirium Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02999542
• Other study ID #: 451/2016
• Status: Not yet recruiting
• Phase: N/A
• First received: December 13, 2016
• Last updated: December 16, 2016
• Start date: January 2017
• Est. completion date: July 2017

Study information

• Verified date: December 2016
• Source: University of Pretoria
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Africa: Medical Research Council
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: July 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 7 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Delirium
• Emergence Delirium

Intervention

Other:
• Music
Children will be randomised to receive either music via headphones or silence via headphones
• No music
Children will be randomised to receive either music via headphones or silence via headphones

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Pretoria

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The effect of music on the prevalence of emergence delirium in paediatric patients		Up to 12 months	No
Secondary	The effect of music therapy on the severity of emergence delirium in paediatric patients.		Up to 12 months	No