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Completed

NCT Number: NCT01463176

Music Therapy as Procedural Support for Young Children Undergoing Immunizations

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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Key information

Conditions

Immunization

Age range

48 month–72 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tallahassee Memorial HealthCare Family Medicine Clinic, Tallahassee, Florida, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Music Therapy

Behavioral

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

Primary outcomes

  1. 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)

    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 outcomes

  1. 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)

    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).

  2. 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).

  3. 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).

  4. 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).

    Assessed by trained observers upon review of a video tape of the procedure (within approximately a month of the procedure)

Sponsors and collaborators

Lead sponsor

Florida State University

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Nov 1, 2011
Registry last updated
Aug 11, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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