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

NCT01858350 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 471

Last updated 2013-05-21

No results posted yet for this study

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

Interventions

OTHER

Active Music Therapy

OTHER

Passive Music Therapy

OTHER

Distraction Therapy

Sponsors & Collaborators

  • Wayne State University

    lead OTHER

Principal Investigators

  • Ambika MATHUR, PhD · Wayne State University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-08-31
Primary Completion
2012-08-31
Completion
2012-08-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01858350 on ClinicalTrials.gov