Music to Reduce Pain and Anxiety in the Pediatric Emergency Department

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00761033
Recruitment Status : Completed
First Posted : September 26, 2008
Last Update Posted : December 8, 2016
Stollery Children's Hospital Foundation
Information provided by:
University of Alberta

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.

Condition or disease Intervention/treatment Phase
Pain Distress Behavioral: music Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : October 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Experimental: music
children will listen to music during procedure
Behavioral: music
Standard care
Standard care
Behavioral: music

Primary Outcome Measures :
  1. Observation Scale of Behavioral Distress-Revised (OSBD-R)

Secondary Outcome Measures :
  1. Pain

Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00761033

Canada, Alberta
Stollery Children's Hospital
Edmonton, Alberta, Canada
Sponsors and Collaborators
University of Alberta
Stollery Children's Hospital Foundation

Publications of Results:
Responsible Party: Lisa Hartling/Assistant Professor, University of Alberta Identifier: NCT00761033     History of Changes
Other Study ID Numbers: B-010908
First Posted: September 26, 2008    Key Record Dates
Last Update Posted: December 8, 2016
Last Verified: December 2016

Keywords provided by University of Alberta:
children undergoing intravenous placement in the pediatric emergency department

Additional relevant MeSH terms:
Disease Attributes
Pathologic Processes