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Not yet recruitingNCT07928089Updated Nov 10, 2026

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

An interventional study of Music Therapy in Sickle Cell Disease, sponsored by University Hospitals Cleveland Medical Center. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-10.

Sponsored by University Hospitals Cleveland Medical Center · Not applicable, Interventional, and Basic science

Updated Nov 10, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
10
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

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.
02

Conditions studied

  • Sickle Cell Disease

Keywords

  • Music Therapy
  • Pain
  • Autonomic
  • Inflammation
03

In context

Anemia, Sickle Cell

1,134 studies on the registry are indexed under Anemia, Sickle Cell; 238 are open to participants now.

This study's planned enrollment of 10 is below the median of 40 across 769 interventional studies indexed under Anemia, Sickle Cell.

Browse Anemia, Sickle Cell studies →

Lead sponsor

University Hospitals Cleveland Medical Center is the lead sponsor of 295 studies on the registry; 45 are open to participants now.

Of its 36 completed or terminated interventional studies of FDA-regulated products, 30 (83%) have results posted.

Browse University Hospitals Cleveland Medical Center studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
10 participants (estimated)

Study arms

  • Experimental
    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

Interventions

  • BehavioralMusic 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.

06

What researchers measure

Primary outcomes

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

    Lower EDA reflects less sympathetic tone

    Time frame: Baseline and after 2 weeks

  2. Change in Quantitative Sudomotor Axon Reflex Test (QSART) as measured by sweat output values

    Lower QSART values reflect less sympathetic activity

    Time frame: Baseline and after 2 weeks

  3. Changes in Pupillometry parameters as measured by constriction velocity

    Faster constriction velocity indicates a higher pupillary vagal tone.

    Time frame: Baseline and after 2 weeks

  4. Changes in Pupillometry parameters as measured by percent reflex amplitude

    Larger percentage of reflex amplitude indicates higher pupillary vagal tone.

    Time frame: Baseline and after 2 weeks

  5. Changes in Pupillometry parameters as measured by dilation velocity.

    Slower dilation velocity indicates lower pupillary sympathetic tone.

    Time frame: Baseline and after 2 weeks.

  6. Change in Heart Rate Response to deep breathing

    Increased heart rate response to deep breathing denotes increased cardiovagal tone.

    Time frame: Baseline and after 2 weeks

  7. Measurement of average supine resting Blood Pressure (BP)

    Lower average resting BP denote lower cardiac sympathetic tone

    Time frame: Baseline and after 2 weeks

  8. Measurement of average supine resting Heart Rate (HR)

    Lower average resting HR denote lower cardiac sympathetic tone

    Time frame: Baseline and after 2 weeks

  9. Change in supine resting respiratory rate

    A lower resting respiratory rate reflects a shift of autonomic balance toward parasympathetic (vagal) dominance with reduced central sympathetic outflow.

    Time frame: Baseline and after 2 weeks

  10. Change in the maximum heart rate during the Valsalva maneuver

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

    Time frame: Baseline and after 2 weeks

  11. Change in the minimum heart rate shortly after the Valsalva maneuver

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

    Time frame: Baseline and after 2 weeks

Secondary outcomes

  1. Change in C Reactive Protein as measured by bloodwork

    Lower levels of CRP indicate lower levels of inflammation

    Time frame: Baseline and after 2 weeks

  2. Change in Cytokine levels as measured by bloodwork

    Lower levels of cytokines indicate lower levels of inflammation

    Time frame: Baseline and after 2 weeks

Other outcomes

  1. Pain intensity changes as measured by the Visual Analog Scale (VAS)

    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".

    Time frame: Baseline and after 2 weeks of daily music therapy

  2. Pain intensity changes as measured by the Brief Pain Inventory (BPI)

    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.

    Time frame: Baseline and after 2 weeks of daily music therapy

  3. Pain diaries

    Daily pain intensity and analgesic use

    Time frame: Daily for 2 weeks

  4. Music therapy adherence

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

    Time frame: Daily for 2 weeks

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Nov 10, 2026
Show all 1 update
  1. Nov 10, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07928089
Lead sponsor
University Hospitals Cleveland Medical Center
Responsible party
Kamal Chemali (Professor of Neurology, University Hospitals Cleveland Medical Center) — Principal investigator
First posted
Nov 10, 2026
Start date
Jan 2, 2027 (estimated)
Primary completion
Jun 30, 2028 (estimated)
Completion
Jun 30, 2028 (estimated)
Last update
Nov 10, 2026

Study contacts

Kaitlyn Super
Contact
kaitlyn.super@uhhospitals.org
216-844-1800
Kamal R Chémali, MD
principal investigator · University Hospitals

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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