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.
調査の概要
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Kaitlyn Super
- 電話番号：216-844-1800
- メール：kaitlyn.super@uhhospitals.org
研究場所
-
-
Ohio
-
Cleveland、Ohio、アメリカ、44106
- University Hospitals
-
コンタクト：
- Kaitlyn Super
- 電話番号：216-844-1800
- メール：kaitlyn.super@uhhospitals.org
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：基礎科学
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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. |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in electrodermal activity (EDA) as measured by change in electrical potential at the surface of the skin
時間枠：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
時間枠：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
時間枠：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
時間枠：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.
時間枠：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
時間枠：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)
時間枠：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)
時間枠：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
時間枠：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
時間枠：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
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in C Reactive Protein as measured by bloodwork
時間枠：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
時間枠：Baseline and after 2 weeks
|
Lower levels of cytokines indicate lower levels of inflammation |
Baseline and after 2 weeks
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Pain intensity changes as measured by the Visual Analog Scale (VAS)
時間枠：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)
時間枠：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
時間枠：Daily for 2 weeks
|
Daily pain intensity and analgesic use |
Daily for 2 weeks
|
|
Music therapy adherence
時間枠：Daily for 2 weeks
|
Daily log of adherence to the home-based music therapy protocol |
Daily for 2 weeks
|
協力者と研究者
捜査官
- 主任研究者：Kamal R Chémali, MD、University Hospitals
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- STUDY20260271
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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