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

Wayne State University

Status: Completed

Conditions: Neurological Disorders

Treatments: Other: Active Music Therapy; Other: Passive Music Therapy; Other: Distraction Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT01858350

RC1AT005699

Details and patient eligibility

About

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.

Enrollment: 471 patients

Sex: All

Ages: 1 to 12 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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471 participants in 4 patient groups

Active Music Therapy

Other group

Description:

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

Treatment:

Other: Active Music Therapy

Passive Music Therapy

Other group

Description:

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

Treatment:

Other: Passive Music Therapy

No intervention

No Intervention group

Distraction Therapy

Other group

Description:

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

Treatment:

Other: Distraction Therapy