- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02799628
Positive Appraisal Improve Trust Between Patients and Therapists, and Change Treatment Effects
The trust between patients and medical providers is the cornerstone to obtain success treatment. To boost the trust can increase medical prescription compliance, enhance patient satisfaction, and improve the effectiveness of treatment. Otherwise, mistrust between medical providers and patients will result in ineffective treatment and excessive defensive health care. This situation may cause medical dispute and medical resources wasting problems.
Most of treatment complete in a few times of admissions and interventions. So, how to improve the trust between patients and doctors quickly became a more knotty problem. Several studies found that speech (including listening, showing compassion, and take longer to explain), reputation, clothing, offer a newer therapy were more important than age, title, and sex.
However, past researches were restricted to an unclear causal relationship. That is they can't be determined whether good doctor-patient relationship and better trust conditions create a longer visit time, better satisfaction, and good reputation, or vice versa. They also unable to clarify whether the high degree of trust result in improved treatment effects, or good relationship result from good medical outcomes.
Investigators want to design a randomized control trial by giving patients recommendation and physical therapist introductions to enhance the trust of patients to therapists. And this study may verify whether enhance trust between therapists and patients will lead to changes in treatment effectiveness.
연구 개요
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Taoyuan, 대만, 33004
- TaoYuan General Hospital
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- First time visit to Taoyuan general hospital rehabilitation ward at 2016/07/01~2017/12/31
- Diagnosis with L spine spondylosis, L spine Herniated Inter-vertebral Disc, or non-acute low back muscle strain
- Suitable for physical therapy with ( Hot packing + interference current therapy + pelvic traction + therapeutic exercise )
- most pain score >2
Exclusion Criteria:
- poor of follow oral order, or patients who can't understand Chinese, including patients with aphasia or dementia
- patient who can not received 4 weeks of physical therapy
- other cause of low back pain which can't treatment with physical therapy, including : (Urinary tract stones, infection, rapid progression disease which need immediately operation)
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 네 배로
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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활성 비교기: intervention
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intervention with recommendation and therapist introduction
low back pain education, and physical therapy 3 times per week
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위약 비교기: placebo
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low back pain education, and physical therapy 3 times per week
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Trust score by The Chinese version of the WFPTS(C-WFPTS) between intervention group and placebo group
기간: The first time data collection for individual 5 mins after the intervention.
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The first time data collection for individual 5 mins after the intervention.
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Success treatment proportion between intervention group and placebo group 4 weeks after intervention
기간: data collection for individual at the 0 and 4th week after clinical visit
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Success treatment is defined as the most pain score decrease from baseline more than 2 degree. ( Pain score change from baseline by Visual Analogue Scale after 4 weeks) |
data collection for individual at the 0 and 4th week after clinical visit
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Trust score by The Chinese version of the WFPTS(C-WFPTS) between intervention group and placebo group
기간: The second time and third time data collection after 2 weeks and 4 weeks after first clinical visit
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The second time and third time data collection after 2 weeks and 4 weeks after first clinical visit
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Change of pain score with The Chinese version of the Brief Pain Inventory (BPI-C) between intervention group and placebo group
기간: data collection for individual at the0, 2nd and 4th week after clinical visit
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Pain score change from baseline
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data collection for individual at the0, 2nd and 4th week after clinical visit
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Change of the compression force to trigger the tenderness point from baseline
기간: data collection for individual at the 0, 2nd and 4th week after clinical visit
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The compression force was measured by IMADA digital force gauge (kgf) In each data collection point(0 , 2nd and 4th week) , we arrange 3 times test and use the average as the measure value.
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data collection for individual at the 0, 2nd and 4th week after clinical visit
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공동 작업자 및 조사자
수사관
- 수석 연구원: Huan-Jui Yeh, Department of Physical Medicine and Rehabilitation, Taoyuan General Hospital, Ministry of Health and Welfare, Taiwan
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
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. .