- ICH GCP
- Registre américain des essais cliniques
- Essai clinique 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.
Aperçu de l'étude
Statut
Intervention / Traitement
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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-
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Taoyuan, Taïwan, 33004
- TaoYuan General Hospital
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-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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)
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Quadruple
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Comparateur actif: intervention
|
intervention with recommendation and therapist introduction
low back pain education, and physical therapy 3 times per week
|
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Comparateur placebo: placebo
|
low back pain education, and physical therapy 3 times per week
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Trust score by The Chinese version of the WFPTS(C-WFPTS) between intervention group and placebo group
Délai: The first time data collection for individual 5 mins after the intervention.
|
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
Délai: data collection for individual at the 0 and 4th week after clinical visit
|
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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Trust score by The Chinese version of the WFPTS(C-WFPTS) between intervention group and placebo group
Délai: The second time and third time data collection after 2 weeks and 4 weeks after first clinical visit
|
The second time and third time data collection after 2 weeks and 4 weeks after first clinical visit
|
|
|
Change of pain score with The Chinese version of the Brief Pain Inventory (BPI-C) between intervention group and placebo group
Délai: data collection for individual at the0, 2nd and 4th week after clinical visit
|
Pain score change from baseline
|
data collection for individual at the0, 2nd and 4th week after clinical visit
|
|
Change of the compression force to trigger the tenderness point from baseline
Délai: data collection for individual at the 0, 2nd and 4th week after clinical visit
|
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.
|
data collection for individual at the 0, 2nd and 4th week after clinical visit
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Huan-Jui Yeh, Department of Physical Medicine and Rehabilitation, Taoyuan General Hospital, Ministry of Health and Welfare, Taiwan
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- TYGH104046
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
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