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OpenTrials
Completed

NCT Number: NCT00761033

Music to Reduce Pain and Anxiety in the Pediatric Emergency Department

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.

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Key information

Age range

3 year–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stollery Children's Hospital

Edmonton, Alberta, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Music

Behavioral

Primary outcomes

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

Secondary outcomes

  1. Pain

Sponsors and collaborators

Lead sponsor

University of Alberta

Other

Collaborators

  • Stollery Children's Hospital Foundation

Registry information

Official study title

Music to Reduce Pain and Anxiety in the Pediatric Emergency Department: a Randomized Controlled Trial of Children 3-6 Years Undergoing Intravenous Placement

Important dates

Study start
2008
First posted
Sep 26, 2008
Registry last updated
Dec 8, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.