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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03901560
Other study ID # IRB 5897
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 30, 2016
Est. completion date July 13, 2017

Study information

Verified date April 2019
Source University of Oklahoma
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study will assess whether participants who receive music therapy during inpatient care report a decrease in pain and whether music therapy influences factors such as family satisfaction.


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.


Recruitment information / eligibility

Status Completed
Enrollment 150
Est. completion date July 13, 2017
Est. primary completion date July 13, 2017
Accepts healthy volunteers
Gender All
Age group 5 Years to 17 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Music Therapy


Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
University of Oklahoma The Children’s Hospital at OU Medical Center

Outcome

Type Measure Description Time frame Safety issue
Primary How does music therapy affect perceived pain in hospitalized pediatric patients? 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
Primary How does music therapy influence factors such as family satisfaction and length of stay at the time of discharge? Will music therapy result in patient and/or family satisfaction as measured by a survey administered immediately after the intervention? 30 minutes
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