Music to Reduce Pain and Anxiety in the Pediatric Emergency Department

Study Overview
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Brief Summary
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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.

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

Conditions
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Pain, Distress

Intervention / Treatment
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* Behavioral: music


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 6 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: music<br>children will listen to music during procedure | Behavioral: music<br> <br> |
| Other: Standard care<br>Standard care | Behavioral: music<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Observation Scale of Behavioral Distress-Revised (OSBD-R) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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children undergoing intravenous placement in the pediatric emergency department