Music Therapy as Procedural Support for Young Children Undergoing Immunizations
1 other identifier
interventional
150
1 country
3
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2011
Shorter than P25 for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2011
CompletedFirst Submitted
Initial submission to the registry
October 20, 2011
CompletedFirst Posted
Study publicly available on registry
November 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2012
CompletedAugust 11, 2015
August 1, 2015
10 months
October 20, 2011
August 10, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Child's behavioral distress, as measured by the Children's Hospital of Eastern Ontario Pain Scale (CHEOPS)
Distress will be assessed at fifteen second intervals throughout the procedure by trained observers upon review of videos of procedures (within approximately one month of procedure)
From the time the nurse enters the treatment room until the child leaves the treatment room after the procedure (approximately 5-10 minutes)
Secondary Outcomes (4)
Child and adult behaviors, as measured by the Child-Adult Medical Procedure Interaction Scale- Short Form (CAMPIS-SF)
From the time the nurse enters the treatment room until the child leaves the treatment room after the procedure (approximately 5-10 minutes)
Child's pain and distress, reported by the child's parent using the Universal Pain Assessment Tool
After the procedure, when the child and parent have left the treatment room (within approximately 5 minutes of the procedure).
Parent perceptions of and satisfaction with the procedure, measured using a researcher-designed satisfaction survey
After the procedure, when the child and parent have left the treatment room (within approximately 5 minutes of the procedure).
Length of time it takes the child to calm after the procedure, in minutes and seconds
Observers will begin recording the length of time to calm starting with the needle insertion and ending when the child receives a CHEOPS score of 6 or less (within approximately 5 minutes after needle insertion).
Study Arms (2)
Standard Care
NO INTERVENTIONChildren in the Standard Care Control group will receive standard care and will be videotaped by the music therapist but will not receive music therapy during their immunization
Music Therapy
EXPERIMENTALChildren in this group will receive live music therapy during their immunization.
Interventions
Live music therapy is interactive and incorporates behavioral cues for coping techniques during the procedure, using patient-preferred music.
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- Any children whose parents are non-English speakers or staff who are non-English speakers will be excluded.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Tallahassee Primary Care Associates
Tallahassee, Florida, 32303, United States
Tallahassee Memorial HealthCare Family Medicine Clinic
Tallahassee, Florida, 32308, United States
Memorial Pediatrics
Bainbridge, Georgia, 39819, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Olivia S Yinger, MME
Florida State University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 20, 2011
First Posted
November 1, 2011
Study Start
October 1, 2011
Primary Completion
August 1, 2012
Study Completion
August 1, 2012
Last Updated
August 11, 2015
Record last verified: 2015-08