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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01858350

Enrollment

471

Registered

2013-05-21

Start date

2009-08-31

Completion date

2012-08-31

Last updated

2013-05-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neurological Disorders

Keywords

CAM, Sedation, MRI, Music Therapy

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.

Interventions

OTHERActive Music Therapy

OTHERPassive Music Therapy

OTHERDistraction Therapy

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

1 Years to 12 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026