- ICH GCP
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- Klinische proef 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.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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Taoyuan, Taiwan, 33004
- TaoYuan General Hospital
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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)
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Verviervoudigen
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Actieve vergelijker: 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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Placebo-vergelijker: placebo
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low back pain education, and physical therapy 3 times per week
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Trust score by The Chinese version of the WFPTS(C-WFPTS) between intervention group and placebo group
Tijdsspanne: 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
Tijdsspanne: 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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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Trust score by The Chinese version of the WFPTS(C-WFPTS) between intervention group and placebo group
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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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Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Huan-Jui Yeh, Department of Physical Medicine and Rehabilitation, Taoyuan General Hospital, Ministry of Health and Welfare, Taiwan
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- TYGH104046
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
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