Music Therapy as Procedural Support for Young Children Undergoing Immunizations - Full Text View

Purpose

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.

Condition	Intervention
Immunization	Behavioral: Music Therapy

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Supportive Care
Official Title:	Music Therapy as Procedural Support for Young Children Undergoing Immunizations: A Randomized Controlled Study

Further study details as provided by Florida State University:

Primary Outcome Measures:

Child's behavioral distress, as measured by the Children's Hospital of Eastern Ontario Pain Scale (CHEOPS) [ Time Frame: From the time the nurse enters the treatment room until the child leaves the treatment room after the procedure (approximately 5-10 minutes) ] [ Designated as safety issue: No ]
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)

Secondary Outcome Measures:

Child and adult behaviors, as measured by the Child-Adult Medical Procedure Interaction Scale- Short Form (CAMPIS-SF) [ Time Frame: From the time the nurse enters the treatment room until the child leaves the treatment room after the procedure (approximately 5-10 minutes) ] [ Designated as safety issue: No ]
Child and adult behaviors 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).
Child's pain and distress, reported by the child's parent using the Universal Pain Assessment Tool [ Time Frame: After the procedure, when the child and parent have left the treatment room (within approximately 5 minutes of the procedure). ] [ Designated as safety issue: No ]
Parent perceptions of and satisfaction with the procedure, measured using a researcher-designed satisfaction survey [ Time Frame: After the procedure, when the child and parent have left the treatment room (within approximately 5 minutes of the procedure). ] [ Designated as safety issue: No ]
Length of time it takes the child to calm after the procedure, in minutes and seconds [ Time Frame: 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). ] [ Designated as safety issue: No ]
Assessed by trained observers upon review of a video tape of the procedure (within approximately a month of the procedure)

Estimated Enrollment:	150
Study Start Date:	October 2011
Estimated Study Completion Date:	April 2012
Estimated Primary Completion Date:	March 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
No Intervention: Standard Care Children 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
Experimental: Music Therapy Children in this group will receive live music therapy during their immunization.	Behavioral: Music Therapy Live music therapy is interactive and incorporates behavioral cues for coping techniques during the procedure, using patient-preferred music.

Eligibility

Ages Eligible for Study:	48 Months to 72 Months
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01463176

Contacts

Contact: Olivia S Yinger, MME

850-443-8703

ols9879@my.fsu.edu

Locations

United States, Florida
Tallahassee Memorial HealthCare Family Medicine Clinic	Not yet recruiting
Tallahassee, Florida, United States, 32308
Contact: David P Robinson, MD 850-431-5430
Principal Investigator: Olivia S Yinger, MME
Tallahassee Primary Care Associates	Recruiting
Tallahassee, Florida, United States, 32303
Contact: Gregory D Perry, MD 850-942-5775
Principal Investigator: Olivia S Yinger, MME
United States, Georgia
Memorial Pediatrics	Not yet recruiting
Bainbridge, Georgia, United States, 39819
Contact: Alicia S Estillore, MD 229-246-1209
Principal Investigator: Olivia S Yinger, MME

Sponsors and Collaborators

Florida State University

Investigators

Principal Investigator:

Olivia S Yinger, MME

Florida State University

More Information

No publications provided

Responsible Party:	Olivia Swedberg Yinger, Doctoral Candidate, Florida State University
ClinicalTrials.gov Identifier:	NCT01463176 History of Changes
Other Study ID Numbers:	2011.6797
Study First Received:	October 20, 2011
Last Updated:	October 28, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by Florida State University:

Music Therapy
Child Psychology
Vaccination

ClinicalTrials.gov processed this record on May 19, 2013