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

4. november 2026 opdateret af: Kamal Chemali, University Hospitals Cleveland Medical Center

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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

10

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Grundvidenskab
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Adfærdsmæssigt: Music Therapy

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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in electrodermal activity (EDA) as measured by change in electrical potential at the surface of the skin
Tidsramme: Baseline and after 2 weeks

Lower EDA reflects less sympathetic tone
Baseline and after 2 weeks
Change in Quantitative Sudomotor Axon Reflex Test (QSART) as measured by sweat output values
Tidsramme: Baseline and after 2 weeks

Lower QSART values reflect less sympathetic activity
Baseline and after 2 weeks
Changes in Pupillometry parameters as measured by constriction velocity
Tidsramme: Baseline and after 2 weeks

Faster constriction velocity indicates a higher pupillary vagal tone.
Baseline and after 2 weeks
Changes in Pupillometry parameters as measured by percent reflex amplitude
Tidsramme: Baseline and after 2 weeks

Larger percentage of reflex amplitude indicates higher pupillary vagal tone.
Baseline and after 2 weeks
Changes in Pupillometry parameters as measured by dilation velocity.
Tidsramme: Baseline and after 2 weeks.

Slower dilation velocity indicates lower pupillary sympathetic tone.
Baseline and after 2 weeks.
Change in Heart Rate Response to deep breathing
Tidsramme: Baseline and after 2 weeks

Increased heart rate response to deep breathing denotes increased cardiovagal tone.
Baseline and after 2 weeks
Measurement of average supine resting Blood Pressure (BP)
Tidsramme: Baseline and after 2 weeks

Lower average resting BP denote lower cardiac sympathetic tone
Baseline and after 2 weeks
Measurement of average supine resting Heart Rate (HR)
Tidsramme: Baseline and after 2 weeks

Lower average resting HR denote lower cardiac sympathetic tone
Baseline and after 2 weeks
Change in supine resting respiratory rate
Tidsramme: 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.
Baseline and after 2 weeks
Change in the maximum heart rate during the Valsalva maneuver
Tidsramme: Baseline and after 2 weeks

An increased Valsalva Ratio (maximum heart rate to the minimum heart rate) reflects an increase in cardiac parasympathetic tone.
Baseline and after 2 weeks
Change in the minimum heart rate shortly after the Valsalva maneuver
Tidsramme: Baseline and after 2 weeks

An increased Valsalva Ratio (maximum heart rate to the minimum heart rate) reflects an increase in cardiac parasympathetic tone.
Baseline and after 2 weeks

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in C Reactive Protein as measured by bloodwork
Tidsramme: Baseline and after 2 weeks

Lower levels of CRP indicate lower levels of inflammation
Baseline and after 2 weeks
Change in Cytokine levels as measured by bloodwork
Tidsramme: Baseline and after 2 weeks

Lower levels of cytokines indicate lower levels of inflammation
Baseline and after 2 weeks

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Pain intensity changes as measured by the Visual Analog Scale (VAS)
Tidsramme: 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".
Baseline and after 2 weeks of daily music therapy
Pain intensity changes as measured by the Brief Pain Inventory (BPI)
Tidsramme: 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.
Baseline and after 2 weeks of daily music therapy
Pain diaries
Tidsramme: Daily for 2 weeks

Daily pain intensity and analgesic use
Daily for 2 weeks
Music therapy adherence
Tidsramme: Daily for 2 weeks

Daily log of adherence to the home-based music therapy protocol
Daily for 2 weeks

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University Hospitals Cleveland Medical Center

Efterforskere

  • Ledende efterforsker: Kamal R Chémali, MD, University Hospitals

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

2. januar 2027

Primær færdiggørelse (Anslået)

30. juni 2028

Studieafslutning (Anslået)

30. juni 2028

Datoer for studieregistrering

Først indsendt

14. oktober 2026

Først indsendt, der opfyldte QC-kriterier

4. november 2026

Først opslået (Faktiske)

10. november 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

10. november 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

4. november 2026

Sidst verificeret

1. oktober 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • STUDY20260271

Plan for individuelle deltagerdata (IPD)

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