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

Neurological Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01858350
• Other study ID #: RC1AT005699
• Status: Completed
• Phase: N/A
• First received: May 13, 2013
• Last updated: May 16, 2013
• Start date: August 2009
• Est. completion date: August 2012

Study information

• Verified date: May 2013
• Source: Wayne State University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 471
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Year to 12 Years

Eligibility

Inclusion Criteria:

• Children ages 1-12 years undergoing MRI studies

Exclusion Criteria:

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

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Nervous System Diseases
• Neurological Disorders

Intervention

Other:
• Active Music Therapy

• Passive Music Therapy

• Distraction Therapy

Locations

Country	Name	City	State
United States	Wayne State University and Children's Hospital of Michigan	Detroit	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Wayne State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Secondary	To measure the effect of the interventions on salivary cortisol and inflammatory cytokines	The aim of this measure was to determine if the interventions changed the levels of salivary cortisol and inflammatory cytokines	Saliva samples were collected before the intervention and then after the MRI was performed (average about 150 minutes).	No