- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT05346822
The Efficacy of Collaborative Patient Education on Total Knee Arthroplasty
The Effects of a Patient-specific Integrated Education Program on Pain, Perioperative Anxiety, and Functional Recovery Following Total Knee Replacement
연구 개요
상세 설명
This is a quasi-experimental design study. The participants received total knee arthroplasty by one single surgeon in two facilities within the same medical system (Kaohsiung Medical University affiliated hospitals). The intervention groups received integrated rehabilitation program including verbal one-on-one education, personalized post-operation rehabilitation during admission and scheduled post-operation follow up by a nurse case manager. The control group received the same surgery with traditional clinical pathway by the single surgeon in another affiliated hospital.
We recorded the pain scores, state-trait anxiety inventory scores, WOMAC(Western Ontario and Mcmaster Universities Arthritis Index) scores, American Knee society scores for these participants.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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-
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Kaohsiung, 대만
- Kaohsiung Medical University Hospital
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria
- Patients over 65 years of age
- Patients scheduled to receive unilateral total knee arthroplasty due to advanced osteoarthritis
- Patients are able to understand the study and express opinions clearly
- Patients are willing to participate in this study and provide informed consents
Exclusion Criteria
- Patients with inflammatory joint disease
- Patients with neurosensory system disease (such as stroke or parkinsonism)
- Patients have intellectual impairment, or dementia.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위화되지 않음
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: integrated rehabilitation program for total knee arthroplasty
the intervention was performed in one KMUH affiliated facility
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Pre-operative education and rehabilitation.
During hospitalization: group rehabilitation education program.
Discharge: post-operative care navigation for total knee arthroplasty
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간섭 없음: normal total knee arthroplasty clinical pathway
no integrated rehabilitatoin program for total knee arthroplasty patients with our conventional clinical pathway
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Visual Analogue Pain Score (VAS)
기간: From admission to 3 months after surgery
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Minimum pain intensity from 0 to Maximum of 10.
Higher scores mean a higher pain intensity.
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From admission to 3 months after surgery
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State-trait Anxiety Inventory (STAI)
기간: From admission to 3 months after surgery
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Peri-operative anxiety scoring system.
STAI varies from a minimum score of 20 to a maximum score of 80. STAI scores are commonly classified as "no or low anxiety" (20-37), "moderate anxiety" (38-44), and "high anxiety" (45-80).
Higher scores mean higher anxiety.
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From admission to 3 months after surgery
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American Knee Society Scores(AKS)
기간: From admission to 3 months after surgery
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The AKS ranges from 100 (normal knee function score) to 0 (worst knee function score).
Higher scores mean a better outcome.
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From admission to 3 months after surgery
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WOMAC (Western Ontario and Mcmaster Universities Arthritis Index)
기간: From admission to 3 months after surgery
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The WOMAC evaluates 3 dimensions : pain(maximal score of 20), stiffness(maximal score of 8), and physical function(maximal score of 68).
Higher scores mean worse outcomes.
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From admission to 3 months after surgery
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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. .