Music to Decrease Pain and Anxiety During Head CTs Performed at the PEds ED
Primary Purpose
Anxiety Disorder of Childhood or Adolescence
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Use of music for anxiety in children
Sponsored by
About this trial
This is an interventional treatment trial for Anxiety Disorder of Childhood or Adolescence
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Use of music for anxiety in children
Control
Arm Description
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.
Children in the Con group received the usual medical care without listening to the music intervention.
Outcomes
Primary Outcome Measures
Visual analogue scale of anxiety
A 100 mm scale completed by the research associate relating the degree of infant anxiety
Secondary Outcome Measures
Modified Ramsey Sedation Scale
A validated 1-6 likert scale for measuring degree of sedation
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02437214
Brief Title
Music to Decrease Pain and Anxiety During Head CTs Performed at the PEds ED
Official Title
Randomized Single Blinded Clinical Trial on Effects of Nursery Songs in Infants and Young Children's Anxiety Prior and During Head CT
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
May 2008 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
July 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Steven Weiss
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
This study is a prospective cohort with a randomized single-blinded intervention with convenience sampling design. Our pediatric emergency medicine department (PED) treats nearly 2,500 patients between 1 and 3 years of age annually in 2008-10 and is a regional referral center for specialty care for our state. All data is collected in the PED between May 2008 and July 2010.
One PED examination room is designated as the study room. The music was stored on an ipod played in a portable speaker. The music is from the Compact Disk(CD), "Baby Go to Sleep." This is a commercially available CD.23 The "Baby Go to Sleep" Compact Disk played a combination of the sound of an actual human heartbeat and children's songs. Tempo changes occurred between each song. During the study, the initial three nursery rhymes were played.
The principal investigator's research associates recruit all patients up to 3 years of age presenting to the PED during the hours they were available. Once situated in the room, children both in the control and experimental group received the usual medical care including the evaluation by attending physician to determine if head CT would be performed or not. After subjects were determined to need a head CT by the attending physicians, they were randomly assigned to either the Control(Con) or experimental(Exp) group. Children in the Con group received the usual medical care while 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. Research associates rated children's anxiety levels using a visual analogue scale(VAS) and Modified Ramsay Sedation Scale(MRSS) before children were transferred to radiology department for head CT then after children was laid down to go through head CT. Researchers associates were blinded to group by wearing headphones that were tested to ensure that they could not hear whether or not music was playing during the intervention phase.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety Disorder of Childhood or Adolescence
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
62 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Use of music for anxiety in children
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Children in the Con group received the usual medical care without listening to the music intervention.
Intervention Type
Other
Intervention Name(s)
Use of music for anxiety in children
Intervention Description
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.
Primary Outcome Measure Information:
Title
Visual analogue scale of anxiety
Description
A 100 mm scale completed by the research associate relating the degree of infant anxiety
Time Frame
up to 10 minutes
Secondary Outcome Measure Information:
Title
Modified Ramsey Sedation Scale
Description
A validated 1-6 likert scale for measuring degree of sedation
Time Frame
up to 10 minutes
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
1 Month
Maximum Age & Unit of Time
36 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven Weiss, MD
Organizational Affiliation
University of New Mexico
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
26782796
Citation
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.
Results Reference
derived
PubMed Identifier
26314215
Citation
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.
Results Reference
derived
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Music to Decrease Pain and Anxiety During Head CTs Performed at the PEds ED
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