Comparison of the Effectiveness of CAM Therapies in Pediatric Patients Undergoing Sedation
1 other identifier
interventional
471
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2009
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2012
CompletedFirst Submitted
Initial submission to the registry
May 13, 2013
CompletedFirst Posted
Study publicly available on registry
May 21, 2013
CompletedMay 21, 2013
May 1, 2013
3 years
May 13, 2013
May 16, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Need for sedation medications for MRI is reduced
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.
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.
Secondary Outcomes (1)
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).
Study Arms (4)
Active Music Therapy
OTHERActive Music Therapy: A music therapist plays music to patients for 15 minutes
Passive Music Therapy
OTHERPassive Music Therapy: A music therapist plays a compact disc (CD) to patients for 15 minutes
No intervention
NO INTERVENTIONDistraction Therapy
OTHERDistraction Therapy: A child life specialist plays with patients for 15 minutes
Interventions
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Wayne State University and Children's Hospital of Michigan
Detroit, Michigan, 48201, United States
MeSH Terms
Conditions
Study Officials
- PRINCIPAL INVESTIGATOR
Ambika MATHUR, PhD
Wayne State University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
May 13, 2013
First Posted
May 21, 2013
Study Start
August 1, 2009
Primary Completion
August 1, 2012
Study Completion
August 1, 2012
Last Updated
May 21, 2013
Record last verified: 2013-05