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

Completed · Not applicable

Conditions studied: Neurological Disorders

In brief

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.

Key facts

Study ID

NCT01858350

Run by

Wayne State University

People needed

471

Starts

2009-08-01

Expected to finish

2012-08-01

Last updated by the study team

2013-05-21

Who can join

Age: 1 and older, up to 12. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Children ages 1-12 years undergoing MRI studies

You may not qualify if…

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

Where it is running

• Wayne State University and Children's Hospital of Michigan — Detroit, Michigan, United States

Full record on ClinicalTrials.gov

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