Mechanisms Within the Autonomic Nervous SysTEm undeRlying MusIc Therapy's aNalgesic Effects in Sickle Cell Disease (MASTERMIND)
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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Kaitlyn Super
- Numéro de téléphone: 216-844-1800
- E-mail: kaitlyn.super@uhhospitals.org
Lieux d'étude
-
-
Ohio
-
Cleveland, Ohio, États-Unis, 44106
- University Hospitals
-
Contact:
- Kaitlyn Super
- Numéro de téléphone: 216-844-1800
- E-mail: kaitlyn.super@uhhospitals.org
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Science basique
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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. |
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. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in electrodermal activity (EDA) as measured by change in electrical potential at the surface of the skin
Délai: 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
Délai: 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
Délai: 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
Délai: 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.
Délai: 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
Délai: 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)
Délai: 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)
Délai: 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
Délai: 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
Délai: 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
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in C Reactive Protein as measured by bloodwork
Délai: 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
Délai: Baseline and after 2 weeks
|
Lower levels of cytokines indicate lower levels of inflammation |
Baseline and after 2 weeks
|
Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Pain intensity changes as measured by the Visual Analog Scale (VAS)
Délai: 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)
Délai: 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
Délai: Daily for 2 weeks
|
Daily pain intensity and analgesic use |
Daily for 2 weeks
|
|
Music therapy adherence
Délai: Daily for 2 weeks
|
Daily log of adherence to the home-based music therapy protocol |
Daily for 2 weeks
|
Collaborateurs et enquêteurs
Les enquêteurs
- Chercheur principal: Kamal R Chémali, MD, University Hospitals
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Manifestations neurologiques
- Processus pathologiques
- Maladies génétiques, innées
- Maladies hématologiques
- Anémie, hémolytique, congénitale
- Anémie, hémolytique
- Anémie
- Hémoglobinopathies
- Maladies et anomalies congénitales, héréditaires et néonatales
- Conditions pathologiques, signes et symptômes
- Signes et symptômes
- Maladies hémiques et lymphatiques
- La douleur
- Inflammation
- Anémie, Drépanocytose
- Thérapeutique
- Thérapies complémentaires
- Soins aux patients
- Psychothérapie
- Disciplines et activités comportementales
- Réhabilitation
- Suivi
- Continuité des soins aux patients
- Thérapies d'art sensorielles
- Musicothérapie
Autres numéros d'identification d'étude
- STUDY20260271
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
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