Comparison of the Effectiveness of CAM Therapies in Pediatric Patients Undergoing Sedation

Study Overview
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Brief Summary
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The investigators conducted a prospective open unblinded clinical four-arm evaluation of Complementary and Alternate Medicine (CAM) interventions on children 1-12 years of age who were undergoing imaging by Medical Resonance Imaging(MRI) and receiving parenteral sedation. Children were assigned to active music therapy, passive music therapy, distraction therapy, and no intervention; measures included doses and numbers of sedation medications, time of sedation, and salivary levels of the stress hormone cortisol and pro-inflammatory cytokines, before and immediately after the intervention was completed. The Time Frame for the outcome measures are at the start of the intervention and immediately following the procedure (generally about 150 minutes). No further follow up was conducted.

Official Title
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Comparison of the Effectiveness of Complementary and Alternative Medicine (CAM) Therapies in Pediatric Patients Undergoing Medical Resonance Imagining (MRI) Studies

Conditions
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Neurological Disorders

Intervention / Treatment
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* Other: Active Music Therapy
* Other: Passive Music Therapy
* Other: Distraction Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children ages 1-12 years undergoing MRI studies Exclusion Criteria: Patients with significant congenital anomalies, genetic syndromes and central nervous system malformations

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Active Music Therapy<br>Active Music Therapy: A music therapist plays music to patients for 15 minutes | Other: Active Music Therapy<br> <br> |
| Other: Passive Music Therapy<br>Passive Music Therapy: A music therapist plays a compact disc (CD) to patients for 15 minutes | Other: Passive Music Therapy<br> <br> |
| No Intervention: No intervention<br> | |
| Other: Distraction Therapy<br>Distraction Therapy: A child life specialist plays with patients for 15 minutes | Other: Distraction Therapy<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Need for sedation medications for MRI is reduced | Intervention is performed prior to sedation. Following sedation, the patient undergoes MRI. After the MRI is completed, the amount of sedation given to the patient is recorded. No other follow up is required. | The Time Frame for the outcome measures are at the start of the intervention and immediately following the procedure (average about 150 minutes). No further follow up was conducted. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To measure the effect of the interventions on salivary cortisol and inflammatory cytokines | The aim of this measure was to determine if the interventions changed the levels of salivary cortisol and inflammatory cytokines | Saliva samples were collected before the intervention and then after the MRI was performed (average about 150 minutes). | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sedation, MRI, Music Therapy, CAM