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

NCT ID: NCT01858350

Last Updated: 2013-05-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

471 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-08-31

Study Completion Date

2012-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Neurological Disorders

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Active Music Therapy

Active Music Therapy: A music therapist plays music to patients for 15 minutes

Group Type OTHER

Active Music Therapy

Intervention Type OTHER

Passive Music Therapy

Passive Music Therapy: A music therapist plays a compact disc (CD) to patients for 15 minutes

Group Type OTHER

Passive Music Therapy

Intervention Type OTHER

No intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

Distraction Therapy

Distraction Therapy: A child life specialist plays with patients for 15 minutes

Group Type OTHER

Distraction Therapy

Intervention Type OTHER

Interventions

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Active Music Therapy

Intervention Type OTHER

Passive Music Therapy

Intervention Type OTHER

Distraction Therapy

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Children ages 1-12 years undergoing MRI studies

Exclusion Criteria

* Patients with significant congenital anomalies, genetic syndromes and central nervous system malformations
Minimum Eligible Age

1 Year

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Wayne State University

OTHER

Sponsor Role lead

Responsible Party

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Ambika Mathur

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ambika MATHUR, PhD

Role: PRINCIPAL_INVESTIGATOR

Wayne State University

Locations

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Wayne State University and Children's Hospital of Michigan

Detroit, Michigan, United States

Site Status

Countries

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United States

Other Identifiers

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RC1AT005699

Identifier Type: NIH

Identifier Source: org_study_id

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