NCT01858350

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 471 (actual)
• Sponsor: Wayne State University · Academic / Other
• Sex: All
• Age: 1 Year – 12 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Neurological Disorders

Interventions

Type	Name	Description
OTHER	Active Music Therapy
OTHER	Passive Music Therapy
OTHER	Distraction Therapy

Timeline

• Start date: 2009-08-01
• Primary completion: 2012-08-01
• Completion: 2012-08-01
• First posted: 2013-05-21
• Last updated: 2013-05-21

Locations

1 site across 1 country: United States