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

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ClinicalTrials.gov Identifier: NCT01858350
Recruitment Status : Completed
First Posted : May 21, 2013
Last Update Posted : May 21, 2013
Sponsor:
Information provided by (Responsible Party):
Ambika Mathur, 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.

Condition or disease Intervention/treatment Phase
Neurological Disorders Other: Active Music Therapy Other: Passive Music Therapy Other: Distraction Therapy Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 471 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of the Effectiveness of Complementary and Alternative Medicine (CAM) Therapies in Pediatric Patients Undergoing Medical Resonance Imagining (MRI) Studies
Study Start Date : August 2009
Actual Primary Completion Date : August 2012
Actual Study Completion Date : August 2012

Arm Intervention/treatment
Active Music Therapy
Active Music Therapy: A music therapist plays music to patients for 15 minutes
Other: Active Music Therapy
Passive Music Therapy
Passive Music Therapy: A music therapist plays a compact disc (CD) to patients for 15 minutes
Other: Passive Music Therapy
No Intervention: No intervention
Distraction Therapy
Distraction Therapy: A child life specialist plays with patients for 15 minutes
Other: Distraction Therapy



Primary Outcome Measures :
  1. Need for sedation medications for MRI is reduced [ Time Frame: 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 :
  1. To measure the effect of the interventions on salivary cortisol and inflammatory cytokines [ Time Frame: 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



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Ages Eligible for Study:   1 Year to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Children ages 1-12 years undergoing MRI studies

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01858350


Locations
United States, Michigan
Wayne State University and Children's Hospital of Michigan
Detroit, Michigan, United States, 48201
Sponsors and Collaborators
Wayne State University
Investigators
Principal Investigator: Ambika MATHUR, PhD Wayne State University

Responsible Party: Ambika Mathur, Professor, Wayne State University
ClinicalTrials.gov Identifier: NCT01858350     History of Changes
Other Study ID Numbers: RC1AT005699 ( U.S. NIH Grant/Contract )
First Posted: May 21, 2013    Key Record Dates
Last Update Posted: May 21, 2013
Last Verified: May 2013

Keywords provided by Ambika Mathur, Wayne State University:
CAM
Sedation
MRI
Music Therapy

Additional relevant MeSH terms:
Nervous System Diseases