Clinical trial NCT01463176: Music Therapy as Procedural Support for Young Children Undergoing Immunizations
Official title: Music Therapy as Procedural Support for Young Children Undergoing Immunizations: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Immunization
Keywords: Music Therapy
Child Psychology
Vaccination
Lead sponsor: Florida State University
Sponsor class: OTHER
First posted: 2011-11-01
Enrollment: 150
Sex: ALL
Minimum age (years): 48
Maximum age (years): 72
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Child's behavioral distress, as measured by the Children's Hospital of Eastern Ontario Pain Scale (CHEOPS)
timeFrame: 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:
measure: Child and adult behaviors, as measured by the Child-Adult Medical Procedure Interaction Scale- Short Form (CAMPIS-SF)
timeFrame: From the time the nurse enters the treatment room until the child leaves the treatment room after the procedure (approximately 5-10 minutes)
measure: Child's pain and distress, reported by the child's parent using the Universal Pain Assessment Tool
timeFrame: After the procedure, when the child and parent have left the treatment room (within approximately 5 minutes of the procedure).
measure: Parent perceptions of and satisfaction with the procedure, measured using a researcher-designed satisfaction survey
timeFrame: After the procedure, when the child and parent have left the treatment room (within approximately 5 minutes of the procedure).
measure: Length of time it takes the child to calm after the procedure, in minutes and seconds
timeFrame: 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).
Other outcomes:
Locations:
city: Tallahassee
country: United States
facility: Tallahassee Primary Care Associates
state: Florida
city: Tallahassee
country: United States
facility: Tallahassee Memorial HealthCare Family Medicine Clinic
state: Florida
city: Bainbridge
country: United States
facility: Memorial Pediatrics
state: Georgia
Study officials:
affiliation: Florida State University
name: Olivia S Yinger, MME
role: PRINCIPAL_INVESTIGATOR
References: