Music Therapy as Procedural Support for Young Children Undergoing Immunizations

Immunization Clinical Trial

Official title:

Music Therapy as Procedural Support for Young Children Undergoing Immunizations: A Randomized Controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01463176
• Other study ID #: 2011.6797
• Status: Completed
• Phase: N/A
• First received: October 20, 2011
• Last updated: August 10, 2015
• Start date: October 2011
• Est. completion date: August 2012

Study information

• Verified date: August 2015
• Source: Florida State University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 48 Months to 72 Months

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Immunization

Intervention

Behavioral:
• Music Therapy
Live music therapy is interactive and incorporates behavioral cues for coping techniques during the procedure, using patient-preferred music.

Locations

Country	Name	City	State
United States	Memorial Pediatrics	Bainbridge	Georgia
United States	Tallahassee Memorial HealthCare Family Medicine Clinic	Tallahassee	Florida
United States	Tallahassee Primary Care Associates	Tallahassee	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Florida State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	Child and adult behaviors, as measured by the Child-Adult Medical Procedure Interaction Scale- Short Form (CAMPIS-SF)	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).	From the time the nurse enters the treatment room until the child leaves the treatment room after the procedure (approximately 5-10 minutes)	No
Secondary	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).	No
Secondary	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).	No
Secondary	Length of time it takes the child to calm after the procedure, in minutes and seconds	Assessed by trained observers upon review of a video tape of the procedure (within approximately a month of the procedure)	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).	No