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

Sponsor

Wayne State University (Other)

Overall Status

Completed

CT.gov ID

NCT01858350

Collaborator

(none)

471

Enrollment

Location

Arms

Duration (Months)

13.1

Patients Per Site Per Month

Study Details

Study Description

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	N/A

Study Design

Study Type:

Interventional

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 :

Aug 1, 2009

Actual Primary Completion Date :

Aug 1, 2012

Actual Study Completion Date :

Aug 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Other: Active Music Therapy Active Music Therapy: A music therapist plays music to patients for 15 minutes	Other: Active Music Therapy
Other: 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
Other: Distraction Therapy Distraction Therapy: A child life specialist plays with patients for 15 minutes	Other: Distraction Therapy

Outcome Measures

Primary Outcome Measures

Need for sedation medications for MRI is reduced [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

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).]
The aim of this measure was to determine if the interventions changed the levels of salivary cortisol and inflammatory cytokines

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Year to 12 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Children ages 1-12 years undergoing MRI studies

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ambika Mathur, Professor, Wayne State University

ClinicalTrials.gov Identifier:

NCT01858350

Other Study ID Numbers:

RC1AT005699

First Posted:

May 21, 2013

Last Update Posted:

May 21, 2013

Last Verified:

May 1, 2013

Keywords provided by Ambika Mathur, Professor, Wayne State University

Additional relevant MeSH terms:

Nervous System Diseases

Study Results

No Results Posted as of May 21, 2013