- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03901560
Music Therapy: Sickle Cell and Pain Crisis
The Effect of Music Therapy on Pediatric Patients Admitted to the Hospital for Sickle Cell or Pain Crisis
Study Overview
Status
Intervention / Treatment
Detailed Description
The purpose of this study is to determine if music therapy services can serve as a viable, necessary, and beneficial aspect of inpatient pain management, distraction, and coping for pediatric patients in the acute care hospital setting. The investigator will note the effect of music therapy services in conjunction with pain scores reported by the participant and an increase in self and family reported coping skills during hospitalization.
Participants will be referred by providers from pain management service, oncology/hematology service, or the gastrointestinal (GI) service for functional and abdominal pain. Participants who meet the criteria for inclusion will be selected. The study will be explained to parents and a consent form will be left for the family to review and sign at their convenience. Participants will provide a pain scale level and vitals before completing the music therapy intervention. Once the music therapy intervention is completed, the pain scale and vitals will be repeated.
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 5-17 years of age
- Admitted for sickle cell crisis, functional abdominal pain, or whom the pediatric pain management team is following.
Exclusion Criteria:
- Non-English speaking
- Under 5 years old and over 17 years old
- Patients who are unable to hear or have a hearing disability
- Developmentally unable to self-report pain levels
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
How does music therapy affect perceived pain in hospitalized pediatric patients?
Time Frame: 30 minutes
|
Do pediatric patients who receive music therapy report a decrease in pain after receiving a music therapy intervention as measured by the Wong Baker Faces Scale?
The Wong Baker Faces Scale uses six different faces to assist child patients in rating their pain on a scale of '0' for no pain to '10' for severe to extreme pain.
|
30 minutes
|
|
How does music therapy influence factors such as family satisfaction and length of stay at the time of discharge?
Time Frame: 30 minutes
|
Will music therapy result in patient and/or family satisfaction as measured by a survey administered immediately after the intervention?
|
30 minutes
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB 5897
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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