Mechanisms Within the Autonomic Nervous SysTEm undeRlying MusIc Therapy's aNalgesic Effects in Sickle Cell Disease (MASTERMIND)
NCT07928089, Not applicable, Not yet recruiting, University Hospitals Cleveland Medical Center
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Mechanisms Within the Autonomic Nervous SysTEm undeRlying MusIc Therapy's aNalgesic Effects in Sickle Cell Disease (MASTERMIND) | ClinicalTrials.gov |
| NCT number | NCT07928089 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 10 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | University Hospitals Cleveland Medical Center | ClinicalTrials.gov |
| Conditions | Sickle Cell Disease | ClinicalTrials.gov |
| Interventions | Music Therapy | ClinicalTrials.gov |
| First posted | 2026-11-10 | ClinicalTrials.gov |
| Last updated | 2026-11-10 | ClinicalTrials.gov |
Registered outcomes 17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Change in electrodermal activity (EDA) as measured by change in electrical potential at the surface of the skin | Baseline and after 2 weeks | Lower EDA reflects less sympathetic tone | ClinicalTrials.gov |
| Primary | Change in Quantitative Sudomotor Axon Reflex Test (QSART) as measured by sweat output values | Baseline and after 2 weeks | Lower QSART values reflect less sympathetic activity | ClinicalTrials.gov |
| Primary | Changes in Pupillometry parameters as measured by constriction velocity | Baseline and after 2 weeks | Faster constriction velocity indicates a higher pupillary vagal tone. | ClinicalTrials.gov |
| Primary | Changes in Pupillometry parameters as measured by percent reflex amplitude | Baseline and after 2 weeks | Larger percentage of reflex amplitude indicates higher pupillary vagal tone. | ClinicalTrials.gov |
| Primary | Changes in Pupillometry parameters as measured by dilation velocity. | Baseline and after 2 weeks. | Slower dilation velocity indicates lower pupillary sympathetic tone. | ClinicalTrials.gov |
| Primary | Change in Heart Rate Response to deep breathing | Baseline and after 2 weeks | Increased heart rate response to deep breathing denotes increased cardiovagal tone. | ClinicalTrials.gov |
| Primary | Measurement of average supine resting Blood Pressure (BP) | Baseline and after 2 weeks | Lower average resting BP denote lower cardiac sympathetic tone | ClinicalTrials.gov |
| Primary | Measurement of average supine resting Heart Rate (HR) | Baseline and after 2 weeks | Lower average resting HR denote lower cardiac sympathetic tone | ClinicalTrials.gov |
| Primary | Change in supine resting respiratory rate | 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. | ClinicalTrials.gov |
| Primary | Change in the maximum heart rate during the Valsalva maneuver | Baseline and after 2 weeks | An increased Valsalva Ratio (maximum heart rate to the minimum heart rate) reflects an increase in cardiac parasympathetic tone. | ClinicalTrials.gov |
| Primary | Change in the minimum heart rate shortly after the Valsalva maneuver | Baseline and after 2 weeks | An increased Valsalva Ratio (maximum heart rate to the minimum heart rate) reflects an increase in cardiac parasympathetic tone. | ClinicalTrials.gov |
| Secondary | Change in C Reactive Protein as measured by bloodwork | Baseline and after 2 weeks | Lower levels of CRP indicate lower levels of inflammation | ClinicalTrials.gov |
| Secondary | Change in Cytokine levels as measured by bloodwork | Baseline and after 2 weeks | Lower levels of cytokines indicate lower levels of inflammation | ClinicalTrials.gov |
| Other | Pain intensity changes as measured by the Visual Analog Scale (VAS) | 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". | ClinicalTrials.gov |
| Other | Pain intensity changes as measured by the Brief Pain Inventory (BPI) | 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. | ClinicalTrials.gov |
| Other | Pain diaries | Daily for 2 weeks | Daily pain intensity and analgesic use | ClinicalTrials.gov |
| Other | Music therapy adherence | Daily for 2 weeks | Daily log of adherence to the home-based music therapy protocol | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)