Music to Reduce Pain and Anxiety in the Pediatric Emergency Department

This study has been completed.
Sponsor:
Collaborator:
Stollery Children's Hospital Foundation
Information provided by:
University of Alberta
ClinicalTrials.gov Identifier:
NCT00761033
First received: September 25, 2008
Last updated: April 16, 2010
Last verified: April 2010
  Purpose

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 Intervention
Pain
Distress
Behavioral: music

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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

Resource links provided by NLM:


Further study details as provided by University of Alberta:

Primary Outcome Measures:
  • Observation Scale of Behavioral Distress-Revised (OSBD-R) [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pain [ Designated as safety issue: No ]

Estimated Enrollment: 42
Study Start Date: October 2008
Arms Assigned Interventions
Experimental: music
children will listen to music during procedure
Behavioral: music
Standard care
Standard care
Behavioral: music

  Eligibility

Ages Eligible for Study:   3 Years to 6 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00761033

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

No publications provided by University of Alberta

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Lisa Hartling/Assistant Professor, University of Alberta
ClinicalTrials.gov Identifier: NCT00761033     History of Changes
Other Study ID Numbers: B-010908
Study First Received: September 25, 2008
Last Updated: April 16, 2010
Health Authority: Canada: Ethics Review Committee

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

Additional relevant MeSH terms:
Emergencies
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on August 21, 2014