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

Not Applicable

Completed

• Conditions: Neurological Disorders
• Interventions: Other: Active Music Therapy; Other: Passive Music Therapy; Other: Distraction Therapy

• Registration Number: NCT01858350
• Lead Sponsor: Wayne State University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-08
• Primary Completion: 2012-08
• Study Completion: 2012-08
• Status Verified: 2013-05
• Study First Submitted: 2013-05-13
• Study First Submitted QC: 2013-05-16
• Last Update Submitted: 2013-05-16
• Study First Posted: 2013-05-21
• Last Update Posted: 2013-05-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 471

Inclusion Criteria

• Children ages 1-12 years undergoing MRI studies

Exclusion Criteria

• Patients with significant congenital anomalies, genetic syndromes and central nervous system malformations

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active Music Therapy	Active Music Therapy	Active Music Therapy: A music therapist plays music to patients for 15 minutes
Passive Music Therapy	Passive Music Therapy	Passive Music Therapy: A music therapist plays a compact disc (CD) to patients for 15 minutes
Distraction Therapy	Distraction Therapy	Distraction Therapy: A child life specialist plays with patients for 15 minutes

Primary Outcome Measures

Name	Time	Method
Need for sedation medications for MRI is reduced	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.	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Wayne State University and Children's Hospital of Michigan; 🇺🇸 Detroit, Michigan, United States