Music to Reduce Pain and Anxiety in the Pediatric Emergency Department

• Sponsor: University of Alberta (Other)
• Overall Status: Completed
• CT.gov ID: NCT00761033
• Collaborator: Stollery Children's Hospital Foundation (Other)
• Enrollment: 42
• Location: 1
• Arms: 2

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Pain; Distress	Behavioral: music	N/A

Study Design

• Study Type: Interventional
• Anticipated 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: Oct 1, 2008

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

1. Pain []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 3 Years to 6 Years
• 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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Stollery Children's Hospital	Edmonton	Alberta	Canada

Sponsors and Collaborators

• University of Alberta
• Stollery Children's Hospital Foundation

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00761033
• Other Study ID Numbers: B-010908
• First Posted: Sep 26, 2008
• Last Update Posted: Dec 8, 2016
• Last Verified: Dec 1, 2016

• Keywords provided by , ,: children undergoing intravenous placement in the pediatric emergency department
• Additional relevant MeSH terms: Emergencies

Study Results

No Results Posted as of Dec 8, 2016