Effect of Music on Emergence Delirium

NCT02999542 | Unknown DMC

• 1 other identifier: 451/2016
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Emergence Delirium

Outcome Measures

Primary Outcomes (1)

• The effect of music on the prevalence of emergence delirium in paediatric patients

  Up to 12 months

Secondary Outcomes (1)

• The effect of music therapy on the severity of emergence delirium in paediatric patients.

  Up to 12 months

Study Arms (2)

Music

EXPERIMENTAL

Children will receive music via headphones

Other: Music

No music

EXPERIMENTAL

Children will listen to silence via headphones

Other: No music

Interventions

Music OTHER

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

Music

No music OTHER

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

No music

Eligibility Criteria

• Age: 2 Years - 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• American society of Anaesthesiologists class 3 and above
• Emergency cases
• Children with hearing problems
• Cognitive impairment

Sponsors & Collaborators

• University of Pretoria: lead

MeSH Terms

Conditions

Emergence Delirium

Interventions

Music Therapy

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Sensory Art Therapies; Complementary Therapies; Therapeutics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: DR

Study Record Dates

• First Submitted: December 13, 2016
• First Posted: December 21, 2016
• Study Start: January 1, 2017
• Primary Completion: June 1, 2017
• Study Completion: July 1, 2017
• Last Updated: December 21, 2016

Record last verified: 2016-12