View Clinical Trial (Medical Research Study)
Music Therapy as Procedural Support for Young Children Undergoing Immunizations: A Randomized Controlled Study
| City: |
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Tallahassee |
| State: |
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Florida |
| Zip Code: |
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32308 |
| Conditions: |
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Immunization |
| Purpose: |
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Many young children undergo medical procedures that are painful and distressing. Negative
experiences during medical procedures can have serious long-term effects, including fear and
avoidance of medical procedures during adulthood. Distraction interventions can help prevent
children from forming negative memories of medical procedures. Live music therapy has been
shown to alleviate pediatric distress during both invasive and non-invasive procedures. The
objective of this study is to examine the effects of music therapy on the child's distress
behaviors and time to calm, as well as the length of the procedure and use of restraint, and
parents' and healthcare staffs' behaviors during the procedure, for young children
undergoing immunizations and influenza vaccinations. It is hypothesized that children
receiving music therapy will show fewer distress behaviors, calm more quickly, and have
shorter procedures with fewer instances of restraint compared to children who receive
standard care. In addition, it is predicted that adults (parents and staff) will show fewer
distress-promoting behaviors during, before, and after the procedures.
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| Study Summary: |
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| Criteria: |
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Inclusion Criteria:
- Participants will be pediatric patients (N = 60) from 48 to 72 months of age who are
undergoing immunizations, as well as their parents/legal guardians (N = 60) and the
healthcare staff who are conducting/assisting with their procedure (N = 60).
Exclusion Criteria:
- Any children whose parents are non-English speakers or staff who are non-English
speakers will be excluded.
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| NCT ID: |
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NCT01463176 |
| Primary Contact: |
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Principal Investigator
Olivia S Yinger, MME
Florida State University
Olivia S Yinger, MME
Phone: 850-443-8703
Email: ols9879@my.fsu.edu
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| Backup Contact: |
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N/A |
| Location Contact: |
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Tallahassee, Florida 32308
United States
David P Robinson, MD
Phone: 850-431-5430
Site Status: Not yet recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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June 19, 2013 |
| Modifications to this listing: |
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