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Completed Not applicable Interventional Accepts healthy volunteers

Music Therapy as Procedural Support for Young Children Undergoing Immunizations

ClinicalTrials.gov ID: NCT01463176

Public ClinicalTrials.gov record NCT01463176. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT01463176
Recruitment status
Completed
Study type
Interventional
Phase
Not applicable
Lead sponsor
Florida State University
Other
Enrollment
150 participants

Conditions and interventions

Conditions

Interventions

Behavioral

Eligibility (public fields only)

Age range
48 Months to 72 Months
Sex
All
Healthy volunteers
Accepts healthy volunteers

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Oct 2011 (Type not available)
Primary completion
Aug 2012 (Actual)
Completion
Aug 2012 (Actual)
Last update posted
Aug 11, 2015

2011 – 2012

United States locations

U.S. sites
3
U.S. states
2
U.S. cities
2
Facility City State ZIP Site status
Tallahassee Primary Care Associates Tallahassee Florida 32303 —
Tallahassee Memorial HealthCare Family Medicine Clinic Tallahassee Florida 32308 —
Memorial Pediatrics Bainbridge Georgia 39819 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01463176, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Aug 11, 2015 · Synced Nov 4, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT01463176 live on ClinicalTrials.gov.

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