Music Therapy as Procedural Support for Young Children Undergoing Immunizations

Study Overview
=================
Brief 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.

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

Conditions
-----------------
Immunization

Intervention / Treatment
-----------------
* Behavioral: Music Therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 48 Months
Maximum Age: 72 Months

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard Care<br>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 | |
| Experimental: Music Therapy<br>Children in this group will receive live music therapy during their immunization. | Behavioral: Music Therapy<br>* Live music therapy is interactive and incorporates behavioral cues for coping techniques during the procedure, using patient-preferred music.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| 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). | 
| 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). | 
| 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). | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Music Therapy, Child Psychology, Vaccination