Music to Reduce Pain and Anxiety in the Pediatric Emergency Department

Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00761033
• Other study ID #: B-010908
• Status: Completed
• Phase: N/A
• First received: September 25, 2008
• Last updated: December 6, 2016
• Start date: October 2008

Study information

• Verified date: December 2016
• Source: University of Alberta
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Years to 6 Years

Eligibility

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).

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Distress
• Emergencies
• Pain

Intervention

Behavioral:
• music

Locations

Country	Name	City	State
Canada	Stollery Children's Hospital	Edmonton	Alberta

Sponsors (2)

Lead Sponsor	Collaborator
University of Alberta	Stollery Children's Hospital Foundation

Country where clinical trial is conducted

Canada, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Observation Scale of Behavioral Distress-Revised (OSBD-R)			No
Secondary	Pain			No