Mechanisms Within the Autonomic Nervous SysTEm undeRlying MusIc Therapy's aNalgesic Effects in Sickle Cell Disease (MASTERMIND)
Sickle Cell Disease
De qué trata este estudio
El registro no identifica actualmente este estudio como reclutando. Consulta su estado antes de planificar una evaluación.
- Tipo de estudio
- De intervención
- Fase
- No aplica
- Rango de edad
- 18 años - No especificado
- Sexo admitido
- Todos los sexos
- Voluntarios sanos
- No aceptados
- Participantes
- 10 Estimado
Estos son puntos de partida, no una decisión de elegibilidad. El equipo debe revisar todos los requisitos.
Las explicaciones y la navegación están en español. Los textos proporcionados por el registro, incluidos títulos, resúmenes y criterios, se conservan en su idioma original. Puedes pedir orientación en español a WCR.
Acerca de la investigación
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.
¿Quién podría participar?
La lista siguiente contiene el texto del patrocinador. Puede incluir condiciones, tratamientos previos, resultados de pruebas y otros requisitos. Aparecer en tu búsqueda no significa que califiques.
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.
Tratamiento, grupos y participación
El registro puede describir tratamientos y duración sin incluir un calendario completo. Pide al equipo las visitas, procedimientos, riesgos, costos y alternativas. Mantén tu atención habitual salvo que tu médico te indique un cambio.
- Asignación
- No aplica
- Enmascaramiento
- Sin enmascaramiento
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.
Qué evalúan los investigadores
Estas medidas indican qué se estudia. No prueban que un tratamiento funcione.
Medidas principales
Change in electrodermal activity (EDA) as measured by change in electrical potential at the surface of the skin
Plazo: Baseline and after 2 weeks
Lower EDA reflects less sympathetic tone
Change in Quantitative Sudomotor Axon Reflex Test (QSART) as measured by sweat output values
Plazo: Baseline and after 2 weeks
Lower QSART values reflect less sympathetic activity
Changes in Pupillometry parameters as measured by constriction velocity
Plazo: Baseline and after 2 weeks
Faster constriction velocity indicates a higher pupillary vagal tone.
Changes in Pupillometry parameters as measured by percent reflex amplitude
Plazo: Baseline and after 2 weeks
Larger percentage of reflex amplitude indicates higher pupillary vagal tone.
Changes in Pupillometry parameters as measured by dilation velocity.
Plazo: Baseline and after 2 weeks.
Slower dilation velocity indicates lower pupillary sympathetic tone.
Change in Heart Rate Response to deep breathing
Plazo: Baseline and after 2 weeks
Increased heart rate response to deep breathing denotes increased cardiovagal tone.
Measurement of average supine resting Blood Pressure (BP)
Plazo: Baseline and after 2 weeks
Lower average resting BP denote lower cardiac sympathetic tone
Measurement of average supine resting Heart Rate (HR)
Plazo: Baseline and after 2 weeks
Lower average resting HR denote lower cardiac sympathetic tone
Change in supine resting respiratory rate
Plazo: Baseline and after 2 weeks
A lower resting respiratory rate reflects a shift of autonomic balance toward parasympathetic (vagal) dominance with reduced central sympathetic outflow.
Change in the maximum heart rate during the Valsalva maneuver
Plazo: Baseline and after 2 weeks
An increased Valsalva Ratio (maximum heart rate to the minimum heart rate) reflects an increase in cardiac parasympathetic tone.
Change in the minimum heart rate shortly after the Valsalva maneuver
Plazo: Baseline and after 2 weeks
An increased Valsalva Ratio (maximum heart rate to the minimum heart rate) reflects an increase in cardiac parasympathetic tone.
Medidas secundarias
Change in C Reactive Protein as measured by bloodwork
Plazo: Baseline and after 2 weeks
Lower levels of CRP indicate lower levels of inflammation
Change in Cytokine levels as measured by bloodwork
Plazo: Baseline and after 2 weeks
Lower levels of cytokines indicate lower levels of inflammation
Otras medidas
Pain intensity changes as measured by the Visual Analog Scale (VAS)
Plazo: Baseline and after 2 weeks of daily music therapy
The VAS is a straight 100 mm line-usually horizontal-with descriptive word anchors at each end representing opposite extremes of a subjective experience, such as 0 being "no pain" and 10 being "worst possible pain".
Pain intensity changes as measured by the Brief Pain Inventory (BPI)
Plazo: Baseline and after 2 weeks of daily music therapy
Brief Pain Inventory (BPI) is a self-administered questionnaire used to evaluate pain severity and how pain interferes with daily life on scales from 0 to 10, with 0 being no pain, and 10 being severe pain.
Pain diaries
Plazo: Daily for 2 weeks
Daily pain intensity and analgesic use
Music therapy adherence
Plazo: Daily for 2 weeks
Daily log of adherence to the home-based music therapy protocol
Revisa las tablas completas y sus limitaciones en el registro oficial.
Abrir resultados oficiales ↗Centros de investigación (1)
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1 centros
University HospitalsCleveland, Ohio, United StatesEstado desconocido
Equipo y fechas
- Patrocinador principal
- University Hospitals Cleveland Medical Center
- Inicio del estudio
- 2 ene 2027 Estimado
- Finalización primaria
- 30 jun 2028 Estimado
- Finalización del estudio
- 30 jun 2028 Estimado
- Primera publicación
- 10 nov 2026 Real
- Última actualización
- 10 nov 2026 Real
Contactos oficiales del estudio
Título oficial del estudio
Mechanisms Within the Autonomic Nervous SysTEm undeRlying MusIc Therapy's aNalgesic Effects in Sickle Cell Disease (MASTERMIND)
Consulta a Wellness Clinical Research
Tu mensaje va a WCR, incluso si otra organización realiza este estudio. WCR puede orientarte, pero podría no realizar este estudio, tener acceso a su equipo ni poder inscribirte.
Fuente: API v2 de ClinicalTrials.gov. Patrocinadores e investigadores envían la información. La NLM no aprueba la seguridad ni la ciencia de todos los estudios registrados. Aviso del registro.
Consultado: 12 nov 2026 · Última actualización del registro: 10 nov 2026