NCT00761033

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 25, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 26, 2008

Completed
5 days until next milestone

Study Start

First participant enrolled

October 1, 2008

Completed
Last Updated

December 8, 2016

Status Verified

December 1, 2016

First QC Date

September 25, 2008

Last Update Submit

December 6, 2016

Conditions

Keywords

children undergoing intravenous placement in the pediatric emergency department

Outcome Measures

Primary Outcomes (1)

  • Observation Scale of Behavioral Distress-Revised (OSBD-R)

Secondary Outcomes (1)

  • Pain

Study Arms (2)

music

EXPERIMENTAL

children will listen to music during procedure

Behavioral: music

Standard care

OTHER

Standard care

Behavioral: music

Interventions

musicBEHAVIORAL
Standard caremusic

Eligibility Criteria

Age3 Years - 6 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stollery Children's Hospital

Edmonton, Alberta, Canada

Location

Related 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.

MeSH Terms

Conditions

Pain

Interventions

Music Therapy

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sensory Art TherapiesComplementary TherapiesTherapeuticsRehabilitationAftercareContinuity of Patient CarePatient CarePsychotherapyBehavioral Disciplines and Activities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 25, 2008

First Posted

September 26, 2008

Study Start

October 1, 2008

Last Updated

December 8, 2016

Record last verified: 2016-12

Locations