Music Therapy as Procedural Support for Young Children Undergoing Immunizations

Florida State University

Status: Completed

Conditions: Immunization

Treatments: Behavioral: Music Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT01463176

2011.6797

Details and patient eligibility

About

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.

Enrollment: 150 patients

Sex: All

Ages: 48 to 72 months old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 2 patient groups

Standard Care

No Intervention group

Description:

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

Music Therapy

Experimental group

Description:

Children in this group will receive live music therapy during their immunization.

Treatment:

Behavioral: Music Therapy