Skip to main content
OpenTrials
Completed

NCT Number: NCT01858350

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 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Neurological Disorders Nervous System Diseases

Age range

1 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wayne State University and Children's Hospital of Michigan

Detroit, Michigan, 48201, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Children ages 1-12 years undergoing MRI studies

Exclusion criteria

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

Treatment and study plan

Active music therapy

Other

Passive Music Therapy

Other

Distraction Therapy

Other

Primary outcomes

  1. Need for sedation medications for MRI is reduced

    Time frame: 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 outcomes

  1. To measure the effect of the interventions on salivary cortisol and inflammatory cytokines

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Wayne State University

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
May 21, 2013
Registry last updated
May 21, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.