MedDataX Logo

Effect of Music on Emergence Delirium

NCT ID: NCT02999542

Last Updated: 2016-12-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-31

Study Completion Date

2017-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Emergence Delirium

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Music

Children will receive music via headphones

Group Type EXPERIMENTAL

Music

Intervention Type OTHER

Children will be randomised to receive either music via headphones or silence via headphones

No music

Children will listen to silence via headphones

Group Type EXPERIMENTAL

No music

Intervention Type OTHER

Children will be randomised to receive either music via headphones or silence via headphones

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Music

Children will be randomised to receive either music via headphones or silence via headphones

Intervention Type OTHER

No music

Children will be randomised to receive either music via headphones or silence via headphones

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

2 Years

Maximum Eligible Age

7 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Pretoria

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

DR. Michelle Olivier

DR

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

451/2016

Identifier Type: -

Identifier Source: org_study_id