Sickle Cell CrisisNCT03901560
Music Therapy: Sickle Cell and Pain Crisis
An observational study of Sickle Cell Crisis and Functional Abdominal Pain, run by University of Oklahoma.
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. Read more about this study
- Who is it for?
- Ages 5 to 17 years
- Conditions the study is for
- Sickle Cell Crisis, Functional Abdominal Pain, Patients Followed by the Pain Team
- What is being tested?
- Music Therapy
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 30 Jun 2016to 13 Jul 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 17 years
- All sexes
- Child
Study population: Patients between the ages of 5-17 who either have sickle cell, are on the pain team, or functional abdominal pain
Who may be able to join
- 5-17 years of age
- Admitted for sickle cell crisis, functional abdominal pain, or whom the pediatric pain management team is following.
Who cannot join
- 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
About this study
Official title: The Effect of Music Therapy on Pediatric Patients Admitted to the Hospital for Sickle Cell or Pain Crisis
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.
Read the 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.
- Being tested
- Music Therapy
- Medical subject headings
- Vaso-Occlusive Crises
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music TherapyOther
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 minutes
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?
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2019
- Study start30 Jun 2016
- Primary completion13 Jul 2017
- Study completion13 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sickle Cell CrisisStudies of the same condition, open and under way.
- More trials run by University of OklahomaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Retrospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Collaborators
- The Children's Hospital at OU Medical Center
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03901560
- Sponsor's protocol ID
- IRB 5897
- Status last verified
- Apr 2019
- First submitted
- 2 Apr 2019
- Last updated
- 5 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Music Therapy on Pediatric Patients Admitted to the Hospital for Sickle Cell or Pain Crisis
- ClinicalTrials.gov ID
- NCT03901560
- Acronym / sponsor ID
- IRB 5897
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Collaborators
- The Children's Hospital at OU Medical Center
- Study start
- 30 Jun 2016 (actual)
- Primary completion
- 13 Jul 2017 (actual)
- Study completion
- 13 Jul 2017 (actual)
- First posted
- 3 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case crossover
- Time perspective
- Retrospective
Who may qualify
- Ages
- 5 to 17 years
- Sex
- All
- Age groups
- Child
- Study population
- Patients between the ages of 5-17 who either have sickle cell, are on the pain team, or functional abdominal pain
Key inclusion criteria (2 listed)
- 5-17 years of age
- Admitted for sickle cell crisis, functional abdominal pain, or whom the pediatric pain management team is following.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Music Therapy | Other | – |
Primary outcome
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.
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?
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2019.
- Individual participant dataSharing planned: Undecided
Related trials for Sickle Cell Crisis
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Safety of Anumigilimab (CSL324) in Adults With Sickle Cell Disease (SCD)
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Hypoxic Red Blood Cells in Sickle Cell Anemia
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Investigating the Mechanistic Effects of Mitapivat in Subjects With Sickle Cell Disease
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Natural History of Sickle Cell Disease
Pain Crisis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Sickle Cell Crisis and Functional Abdominal Pain, run by University of Oklahoma.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
How does music therapy affect perceived pain in hospitalized pediatric patients? (time frame: 30 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2019.