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.
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
연구 유형
연구 유형
등록 (추정된)
등록
단계
단계
- 해당 없음
연락처 및 위치
연구 연락처
연구 연락처
- 이름: Kaitlyn Super
- 전화번호: 216-844-1800
- 이메일: kaitlyn.super@uhhospitals.org
연구 장소
-
-
Ohio
-
Cleveland, Ohio, 미국, 44106
- University Hospitals
-
연락하다:
- Kaitlyn Super
- 전화번호: 216-844-1800
- 이메일: kaitlyn.super@uhhospitals.org
-
-
참여기준
자격 기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 기초 과학
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
|
실험적: 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. |
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change in electrodermal activity (EDA) as measured by change in electrical potential at the surface of the skin
기간: 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
기간: 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
기간: 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
기간: 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.
기간: 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
기간: 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)
기간: 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)
기간: 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
기간: 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
기간: 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
기간: 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
|
2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change in C Reactive Protein as measured by bloodwork
기간: 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
기간: Baseline and after 2 weeks
|
Lower levels of cytokines indicate lower levels of inflammation |
Baseline and after 2 weeks
|
기타 결과 측정
기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Pain intensity changes as measured by the Visual Analog Scale (VAS)
기간: 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)
기간: 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
기간: Daily for 2 weeks
|
Daily pain intensity and analgesic use |
Daily for 2 weeks
|
|
Music therapy adherence
기간: Daily for 2 weeks
|
Daily log of adherence to the home-based music therapy protocol |
Daily for 2 weeks
|
공동 작업자 및 조사자
수사관
수사관
- 수석 연구원: Kamal R Chémali, MD, University Hospitals
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
연구 시작
기본 완료 (추정된)
기본 완료
연구 완료 (추정된)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
기타 연구 ID 번호
- STUDY20260271
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .