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NCT01858350 · ClinicalTrials.gov registry record · NA
Comparison of the Effectiveness of CAM Therapies in Pediatric Patients Undergoing Sedation
A NA study, sponsored by Wayne State University.
- Completed
- Registry status
- NA
- Development phase
- 471
- Enrollment target
NCT01858350: Completed NA study, sponsored by Wayne State University.
NCT01858350 is a NA study that has completed, run by Wayne State University. The registered enrollment target is 471 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (66% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01858350, a NA study, has completed, sponsored by Wayne State University.
- COMPLETED
- Registry status
- NA
- Development phase
- 471 participants
- Enrollment target
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.
Primary Outcome
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.
Interventions
- OTHER Active Music Therapy
- OTHER Passive Music Therapy
- OTHER Distraction Therapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 471 participants |
| Start Date | 2009-08 |
| Est. Completion | 2012-08 |
| Phase | NA |
What the finished NCT01858350 record still lists
NCT01858350 is an interventional study that assigns participants to a tested intervention. The registered 471 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (66% lower).
The record links to 0 conditions, and to 3 interventions - of which Active Music Therapy is the first listed.
NCT01858350 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01858350 about?
NCT01858350 is a clinical study titled "Comparison of the Effectiveness of CAM Therapies in Pediatric Patients Undergoing Sedation". 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 a...
What is the current status of trial NCT01858350?
This trial is currently completed. It is a NA study. The enrollment target is 471 participants. The study started on 2009-08. Estimated completion is 2012-08.
What interventions are being tested in trial NCT01858350?
The interventions under investigation include: Active Music Therapy (OTHER), Passive Music Therapy (OTHER), Distraction Therapy (OTHER).
Who is sponsoring clinical trial NCT01858350?
This trial is sponsored by Wayne State University, which has 163 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01858350's enrollment target sits among peer trials
471 221st of 2000 higher than 1,780 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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