Effect of Music on Emergence Delirium
Primary Purpose
Emergence Delirium
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Music
No music
Sponsored by
About this trial
This is an interventional prevention trial for Emergence Delirium
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Music
No music
Arm Description
Children will receive music via headphones
Children will listen to silence via headphones
Outcomes
Primary Outcome Measures
The effect of music on the prevalence of emergence delirium in paediatric patients
Secondary Outcome Measures
The effect of music therapy on the severity of emergence delirium in paediatric patients.
Full Information
NCT ID
NCT02999542
First Posted
December 13, 2016
Last Updated
December 16, 2016
Sponsor
University of Pretoria
1. Study Identification
Unique Protocol Identification Number
NCT02999542
Brief Title
Effect of Music on Emergence Delirium
Official Title
The Effect of Intraoperative Music on the Prevalence and Severity of Emergence Delirium in Paediatric Patients: A Randomised Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
December 2016
Overall Recruitment Status
Unknown status
Study Start Date
January 2017 (undefined)
Primary Completion Date
June 2017 (Anticipated)
Study Completion Date
July 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pretoria
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Emergence Delirium
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Music
Arm Type
Experimental
Arm Description
Children will receive music via headphones
Arm Title
No music
Arm Type
Experimental
Arm Description
Children will listen to silence via headphones
Intervention Type
Other
Intervention Name(s)
Music
Intervention Description
Children will be randomised to receive either music via headphones or silence via headphones
Intervention Type
Other
Intervention Name(s)
No music
Intervention Description
Children will be randomised to receive either music via headphones or silence via headphones
Primary Outcome Measure Information:
Title
The effect of music on the prevalence of emergence delirium in paediatric patients
Time Frame
Up to 12 months
Secondary Outcome Measure Information:
Title
The effect of music therapy on the severity of emergence delirium in paediatric patients.
Time Frame
Up to 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
7 Years
Accepts Healthy Volunteers
No
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
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Effect of Music on Emergence Delirium
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