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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
Steven Weiss
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anxiety Disorder of Childhood or Adolescence

Eligibility Criteria

1 Month - 36 Months (Child)MaleAccepts Healthy Volunteers

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

    First Posted
    April 16, 2015
    Last Updated
    October 11, 2023
    Sponsor
    Steven Weiss
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    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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