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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
University of Pretoria
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Emergence Delirium

Eligibility Criteria

2 Years - 7 Years (Child)All SexesDoes not accept healthy volunteers

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

    First Posted
    December 13, 2016
    Last Updated
    December 16, 2016
    Sponsor
    University of Pretoria
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    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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