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Music to Reduce Pain and Anxiety in the Pediatric Emergency Department

Primary Purpose

Pain, Distress

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
music
Sponsored by
University of Alberta
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain focused on measuring children undergoing intravenous placement in the pediatric emergency department

Eligibility Criteria

3 Years - 6 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Children attending the pediatric ED between the ages of 3 and 6 years - Undergoing an IV placement
  • Conscious
  • Have sufficient knowledge of the English language to understand and follow instructions and complete the age-appropriate pain assessment

Exclusion Criteria:

  • Children with hearing impairments, developmental disabilities, or sensory impairment to pain (e.g., spina bifida)
  • Children will be excluded at the discretion of the attending staff (e.g., child in critical condition; requires urgent IV placement; or has altered level of consciousness).

Sites / Locations

  • Stollery Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

music

Standard care

Arm Description

children will listen to music during procedure

Standard care

Outcomes

Primary Outcome Measures

Observation Scale of Behavioral Distress-Revised (OSBD-R)

Secondary Outcome Measures

Pain

Full Information

First Posted
September 25, 2008
Last Updated
December 6, 2016
Sponsor
University of Alberta
Collaborators
Stollery Children's Hospital Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT00761033
Brief Title
Music to Reduce Pain and Anxiety in the Pediatric Emergency Department
Official Title
Music to Reduce Pain and Anxiety in the Pediatric Emergency Department: a Randomized Controlled Trial of Children 3-6 Years Undergoing Intravenous Placement
Study Type
Interventional

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
October 2008 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
University of Alberta
Collaborators
Stollery Children's Hospital Foundation

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Many medical procedures aimed at helping children can cause them pain and distress. If children experience certain levels of pain or distress, it can have long lasting negative effects. The emergency department can be a particularly stressful place for children and their parents. There are also many procedures that children may have in the emergency department that can cause pain and distress. These include procedures such as needle pokes, stitches, or setting a broken bone. Two common methods of managing a child's pain in the emergency department are drugs and distraction. Drugs are not always practical and may come with unwanted side effects. Distraction is often used formally or informally and by parents or the health professionals. One form of distraction involves listening to music. This can lower the child's pain and distress by moving their attention from the painful stimulus, for example a needle poke, to a more pleasant sensation such as familiar children's songs. This study will test whether music is useful to help lower pain and distress for young children (ages 3 to 6 years) who are visiting an emergency department and need an intravenous line. Music is safe and pleasant for children. The results from this study could be important for many children receiving medical care.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Distress
Keywords
children undergoing intravenous placement in the pediatric emergency department

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
42 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
music
Arm Type
Experimental
Arm Description
children will listen to music during procedure
Arm Title
Standard care
Arm Type
Other
Arm Description
Standard care
Intervention Type
Behavioral
Intervention Name(s)
music
Primary Outcome Measure Information:
Title
Observation Scale of Behavioral Distress-Revised (OSBD-R)
Secondary Outcome Measure Information:
Title
Pain

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Children attending the pediatric ED between the ages of 3 and 6 years - Undergoing an IV placement Conscious Have sufficient knowledge of the English language to understand and follow instructions and complete the age-appropriate pain assessment Exclusion Criteria: Children with hearing impairments, developmental disabilities, or sensory impairment to pain (e.g., spina bifida) Children will be excluded at the discretion of the attending staff (e.g., child in critical condition; requires urgent IV placement; or has altered level of consciousness).
Facility Information:
Facility Name
Stollery Children's Hospital
City
Edmonton
State/Province
Alberta
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
23857075
Citation
Hartling L, Newton AS, Liang Y, Jou H, Hewson K, Klassen TP, Curtis S. Music to reduce pain and distress in the pediatric emergency department: a randomized clinical trial. JAMA Pediatr. 2013 Sep;167(9):826-35. doi: 10.1001/jamapediatrics.2013.200.
Results Reference
result

Learn more about this trial

Music to Reduce Pain and Anxiety in the Pediatric Emergency Department

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