가슴 또는 척추 수술 후 수술 후 통증에 대한 종합적 연구
2024년 4월 9일 업데이트: Children's Hospital Medical Center, Cincinnati
흉부 또는 척추 수술 후 수술 후 통증의 유전적, 후성적, 심리사회적 및 생물학적 결정요인
통증 인식, 수술 후 통증, 진통 효과, 수술 전후 진통제의 부작용, 수술 후 만성 통증 및 유전자로 정의되는 표현형과 특정 유전자형, 후성유전학, 행동적, 사회적 및 생물학적 요인 간의 연관성을 결정하는 전향적 연구입니다. 오목가슴 수리 후 환자의 발현.
연구 개요
상세 설명
이 연구는 임상적 전향적 연구가 될 것입니다.
그것은 100명의 가슴과 100명의 척추 참가자로 제한되는 명상 개입을 제외하고 모든 목표에 대해 관찰적입니다(각 팔에서 50/50으로 무작위화됨).
연구 기간 동안 600명의 적격 참가자를 모집하여 표현형과 유전자형이 일치하는 예측 모델을 도출하는 데 필요한 데이터를 수집할 것입니다.
이 연구는 유치선에서 혈액을 채취하고 무작위 명상 그룹을 위한 추가 통합 건강 절차(집중 주의 명상 지도, 일상적인 마사지 및 호흡 기술)를 사용하는 것을 제외하고는 표준 마취 또는 수술 전후 관리를 방해하지 않습니다. .
연구원은 참가자의 의료 기록에서 관련 데이터를 기록할 뿐만 아니라 심리사회적 및 체감각 평가를 관리합니다.
통합 건강은 수술 전 단계에서 무작위 명상 참가자에게 집중 주의 명상을 가르치는 데 도움이 될 것입니다.
액티그래피 장치는 모든 참가자에게 제공되며 MUSETM은 무작위 명상 그룹의 참가자에게 제공됩니다.
통증 팀은 가슴 통증 관리 프로토콜에 따라 수술 전후 통증 관리를 지시합니다.
연구 유형
중재적
등록 (추정된)
600
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Ohio
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Cincinnati, Ohio, 미국, 45229
- Cincinnati Childrens Hospital Medical Center
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
8년 이상 (어린이, 성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
설명
포함 기준:
- 만 8세부터 성인까지의 어린이
- 오목가슴 또는 청소년 특발성 척추 측만증의 진단
- 내시경적 오목가슴 수리 또는 척추 융합 예정
제외 기준:
- 활동성 신장 또는 간 질환의 병력
- 지난 5년 동안 오피오이드를 필요로 하는 대수술
- 심각한 호흡기 문제(지난 달 폐쇄성 수면 무호흡증, 낭포성 섬유증, 폐 섬유증 또는 폐렴 등)
- 청색증 심장 질환, 저형성 좌심실, 부정맥, 지속적인 치료가 필요한 고혈압, 가와사키병 또는 심근병증을 포함하되 이에 국한되지 않는 심장 상태. 무증상 판막 병변 또는 결함이 있는 참가자가 포함될 수 있습니다.
- 현재 약물로 치료 중인 발작의 병력(약물을 끊고 1년 이상 발작이 없는 참가자가 포함될 수 있음)
- 파록세틴, 플루옥세틴, 시메티딘 및 둘록세틴을 포함하여 CYP2D6 활성을 유도하거나 억제하는 것으로 알려진 병용 약물을 2개 이하로 복용
- 수술 후 환기 또는 수술 중 심장 바이패스 대기가 필요한 경우
- BMI >35
- 임신 또는 수유 중인 여성
- 비영어권
- 명확한 발달 지연
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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간섭 없음: 제어
통제 그룹의 참가자는 수술 후 통합 치료를 통한 참가자/가족 요구 평가와 면허/공인 전체론적 건강 전문가의 표준 전체론적 건강 관리를 포함하는 현재 표준 치료를 받게 됩니다.
그들은 MUSETM 집중 주의 명상 훈련이나 개입 프로토콜을 받지 않을 것입니다.
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실험적: 심사 숙고
집중 주의 명상 교육을 받도록 무작위로 배정된 참가자는 면허/공인 전체적 건강 전문가가 제공하는 수술 전 교육 세션에 참석하게 됩니다.
콘텐츠에는 호흡을 초점으로 사용하는 집중 주의 명상에 대한 연령에 적합한 설명이 포함됩니다. MUSETM 헤드밴드의 설정 및 활용; 그리고 경험적 관행.
개입의 목표는 마음챙김(즉, 감각, 감정 및 생각에 대한 매 순간, 비판단적 및 비반응적 인식)을 증가시키고, 자기 조절 전략을 제공하며, 스트레스에 대한 건강하고 적응적인 반응을 촉진하는 것입니다.
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명상 개입에 배정된 참가자는 수술 전에 집중 주의 명상 훈련을 받고 수술 전 매일 20분 동안 명상하도록 권장됩니다.
수술 후 입원 기간에 참가자는 표준 전체론적 건강 관리, 명상 훈련 강화, 바이오 피드백을 위한 MUSETM 헤드밴드를 활용하여 호흡을 중심으로 최소 20분의 안내 집중 명상을 연습하도록 격려받을 것입니다. 입원 기간 동안 매일.
그들은 퇴원 후 통증 테스트를 반복하기 위해 방문할 때까지 MUSETM 뉴로피드백 보조 명상을 계속 사용하도록 요청받을 것이며, 그 때 그들은 MUSETM 헤드밴드를 반환할 것입니다.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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통증 점수 궤적
기간: 일년
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통증 점수는 수술 후 1년 동안 수술 전 수집됩니다.
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일년
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자가 보고한 심리사회적 점수의 변화(불안, 통증, 대처, 신체적 제한 등 포함)
기간: 일년
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심리 사회적 측정은 수술 후 1년 동안 수술 전 수집됩니다.
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일년
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심박 변이도의 변화
기간: 8주
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심장 박동 변이도는 수술 전과 수술 후 평가됩니다.
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8주
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그룹(개입/무개입) 및 시간(수술 전/수술 후)에 따른 하위, 상위 및 전체 알파 주파수 대역에 대한 평균 진폭 값의 변화
기간: 8주
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뇌 활동은 수술 전 및 수술 후 평가됩니다.
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8주
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명상 및 실험적 통증 작업 중 유발 반응 전위(ERP)의 변화
기간: 8주
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뇌 활동은 수술 전 및 수술 후 평가됩니다.
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8주
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수면 효율/지속 시간(액티그래피) 및 자가 보고 수면 품질의 변화
기간: 8주
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수면 효율성과 질은 수술 전과 수술 후 평가됩니다.
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8주
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부작용 조치의 발생률
기간: 수술 후 72시간
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호흡 억제, 진정, 수술 후 메스꺼움 및 구토의 발생률은 회복 단계에서 수집됩니다.
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수술 후 72시간
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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압박 통증 역치, 조절 통증 조절, 촉각 식별 및 시간 합산 지수의 변화
기간: 8주
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정량적 감각 검사는 수술 전 및 수술 후 평가됩니다.
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8주
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Vidya Chidambaran, MD, Children's Hospital Medical Center, Cincinnati
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
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연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2018년 7월 6일
기본 완료 (추정된)
2024년 12월 31일
연구 완료 (추정된)
2024년 12월 31일
연구 등록 날짜
최초 제출
2018년 9월 20일
QC 기준을 충족하는 최초 제출
2019년 7월 23일
처음 게시됨 (실제)
2019년 7월 24일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2024년 4월 10일
QC 기준을 충족하는 마지막 업데이트 제출
2024년 4월 9일
마지막으로 확인됨
2024년 1월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 2017-5817
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
예
IPD 계획 설명
익명화된 데이터는 추가 내부 또는 외부 데이터 웨어하우스/조사자와 공유될 수 있습니다.
여기에는 i2b2 데이터베이스를 통해 이 데이터를 참가자의 전자 의료 기록의 비식별 사본에 연결하기 위한 CCHMC의 i2b2-연구 데이터 웨어하우스 프로토콜(IRB 2008-0834)이 포함되지만 이에 국한되지 않습니다.
그 결과 식별되지 않은 i2b2 데이터베이스는 이 연구의 일부가 아니며 향후 연구 연구 및 NIH-db-GaP(유전자형 및 표현형 데이터베이스)에서 2차 표현형을 탐색하는 데 사용될 것입니다.
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
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. .