Music Therapy as Procedural Support for Young Children Undergoing Immunizations

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2012-08-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Immunization

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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

Group Type NO_INTERVENTION

No interventions assigned to this group

Music Therapy

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

Group Type EXPERIMENTAL

Music Therapy

Intervention Type BEHAVIORAL

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

Interventions

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Music Therapy

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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).