Mechanisms Within the Autonomic Nervous SysTEm undeRlying MusIc Therapy's aNalgesic Effects in Sickle Cell Disease (MASTERMIND)
Key facts
- Where
- Cleveland, Egyesült ÁllamokSee the site
Where in Egyesült Államok
- University HospitalsCleveland, Egyesült ÁllamokNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University Hospitals Cleveland Medical Center
- Trial code
- NCT07928089
- Record updated
- 2026. november 10.
- Original description
Sickle cell disease causes very painful episodes that can happen without warning. Pain is one of the biggest problems for people with SCD. Medicines like opioids can help, but they have serious side effects. Doctors are looking for other ways to treat pain.Read full original descriptionShow less
Sickle cell disease causes very painful episodes that can happen without warning. Pain is one of the biggest problems for people with SCD. Medicines like opioids can help, but they have serious side effects. Doctors are looking for other ways to treat pain.
Investigators have already found that music therapy - breathing exercises guided by a trained music therapist - can lower pain in adults with SCD. But investigators don't know exactly how it works yet inside the body.
This study will look at two possible reasons why music therapy helps:
* It may calm the body's "fight-or-flight" (sympathetic) nervous system, which can make pain worse when it is too active. * It may boost the "calming" (parasympathetic) nervous system, which may ease pain and reduce inflammation. * It may lower swelling and inflammation in the body, which also drives pain.
Inclusion: (1) are age ≥18 years; (2) have a diagnosis of SCD documented in the electronic health record (EHR)--- (3) meet Analgesic, Anesthetic, and Addiction Clinical Trial Translations Innovations Opportunities and Networks-American Pain Society Pain Taxonomy (AAPT) criteria for chronic SCD pain; (4) are able to speak and understand English; (5) have an email address and access to a mobile device with a functioning data plan (to get pain diaries); (6) report that pain interfered with daily activities at least 1-2 days in past week will be eligible for the study. -.
Exclusion: (3) are currently engaged in mind-body therapies under the supervision of a healthcare professional specifically for pain management; (5) are unable or unwilling to refrain from stopping all medications that interfere with the autonomic nervous system for 5 half-lives prior to autonomic testing and from changing their medication regimen during the 2 weeks that separate autonomic testings and blood draws; (2) have significant visual, hearing, psychiatric or cognitive impairment; (4) have a planned major medical event in next 8 weeks (e.g., childbirth, orthopedic surgery, gene therapy, stem cell transplant) that does not include routine disease modifying therapies (e.g., blood transfusions); (7) have conditions that would significantly affect autonomic testing interpretation, such as severe arrhythmias or pregnancy, will be excluded from the study; (1) have < 3 vaso-occlusive crises (VOCs) per year and no VOCs in the past 3 months; (6) develop active VOC requiring hospitalization at enrollment.