Music to Decrease Pain and Anxiety During Head CTs Performed at the PEds ED

NCT02437214 | Completed

• 1 other identifier: 07-030
• Study Type: interventional
• Target: 62
• Locations: 0 countries
• Sites: N/A

Brief Summary

A single blinded controlled trial to determine if an intervention of listening to nursery songs with integrated heart beat sounds results in changes in anxiety level in infants and young children less than four years of age in an emergent setting.

Conditions

Anxiety Disorder of Childhood or Adolescence

Outcome Measures

Primary Outcomes (1)

• Visual analogue scale of anxiety

  A 100 mm scale completed by the research associate relating the degree of infant anxiety

  up to 10 minutes

Secondary Outcomes (1)

• Modified Ramsey Sedation Scale

  up to 10 minutes

Study Arms (2)

Use of music for anxiety in children

EXPERIMENTAL

Children in the Exp group received the usual medical care in combination with the intervention. The intervention was started by the patients nurse without the knowledge of the research associate. In the intervention group, music was played until the CT scan was completed.

Other: Use of music for anxiety in children

Control

NO INTERVENTION

Children in the Con group received the usual medical care without listening to the music intervention.

Interventions

Use of music for anxiety in children OTHER

The "Baby Go to Sleep" CD played a combination of the sound of an actual human heartbeat and children's songs. The concept behind the "Baby Go to Sleep" CD is to blend heart beat sounds, which are known to be calming to infants and children, with children's music. The basic principles of relaxation were incorporated in the arrangements of heartbeat and children's songs, ie: simplicity, repetition, predictability, and simple symmetry (short repeated patterns). The adult human heart in the "Baby Go to Sleep" CD was recorded from the chest and set in consistent tempos for each song ranging from 62 to 78 beats per minute(BPM). The sound of the heartbeat continued between and during songs. Tempo changes occurred between each song.

Use of music for anxiety in children

Eligibility Criteria

• Age: 1 Month - 36 Months
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• We sampled all children up to ages 3 years who present to the PED during the hours that the research assistant was present to collect data.

You may not qualify if:

• All children requiring trauma room care were excluded because they were not able to move to the study's examination room after triage (their care will be completed in the trauma room). Children with hearing deficit and those who are unable to move to the designated examination room for other reasons including needing oxygen and cardiopulmonary monitoring were excluded as well. The patients were also excluded if we were unable to track their results or chart at final review of patient data.

Sponsors & Collaborators

• Steven Weiss: lead

Related Publications (2)

• Park G, Weiss SJ, Repar P. Randomized single-blinded clinical trial on effects of nursery songs for infants and young children's anxiety before and during head CT. Am J Emerg Med. 2016 Mar;34(3):663. doi: 10.1016/j.ajem.2015.12.049. Epub 2015 Dec 21. No abstract available.

  PMID: 26782796 DERIVED

• Park G, Weiss SJ, Repar P. Randomized single-blinded clinical trial on effects of nursery songs for infants and young children's anxiety before and during head computed tomography. Am J Emerg Med. 2015 Oct;33(10):1477-82. doi: 10.1016/j.ajem.2015.07.045. Epub 2015 Jul 29.

  PMID: 26314215 DERIVED

Study Officials

• Steven Weiss, MD

  University of New Mexico

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Emergency Medicine

Study Record Dates

• First Submitted: April 16, 2015
• First Posted: May 7, 2015
• Study Start: May 1, 2008
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2010
• Last Updated: October 13, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share