Not yet recruitingNCT07928089ClinicalTrials.gov record

Mechanisms Within the Autonomic Nervous SysTEm undeRlying MusIc Therapy's aNalgesic Effects in Sickle Cell Disease (MASTERMIND)

Sickle Cell Disease

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THE QUICK READ

What this study involves

The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.

Study type: Interventional
Phase: Not applicable
Age range: 18 years - Not specified
Sex eligible: All sexes
Healthy volunteers: Not accepted
Participants: 10 Estimated

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

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.

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

Inclusion Criteria:

(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 Criteria:

(1) have \< 3 vaso-occlusive crises (VOCs) per year and no VOCs in the past 3 months
(2) have significant visual, hearing, psychiatric or cognitive impairment
(3) are currently engaged in mind-body therapies under the supervision of a healthcare professional specifically for pain management
(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)
(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
(6) develop active VOC requiring hospitalization at enrollment
(7) have conditions that would significantly affect autonomic testing interpretation, such as severe arrhythmias or pregnancy, will be excluded from the study.

Understand screening

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment: Not applicable
Masking: No masking

Music Therapy

The MT-BC will engage the participant in a 20-minute deep breathing exercise with live music beating at a defined tempo. Participants will repeat this session on their own.

Behavioral: Music Therapy

Music Therapy BEHAVIORAL

Participants will undergo a 20-minute music therapy session with a board certified music therapist, then will repeat this on their own once daily for 2 weeks.

Prepare your questions

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

Change in electrodermal activity (EDA) as measured by change in electrical potential at the surface of the skin