- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT03665727
Psychosocial Support for Pre-operative Pain and Distress (Mind-Body JRA)
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Utah
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Salt Lake City, Utah, États-Unis, 84112
- University of Utah
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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:
- English-speaking males or females
- 18 years old or older
- patients within the University of Utah Hospital system
- patients attending the Joint Replacement Academy to prepare for either hip or knee replacement surgery
Exclusion Criteria:
- Altered mental status due to delirium, psychosis, or pharmacological sedation as determined by clinical assessment.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Expérimental: Mindfulness
15 minute mindfulness session
|
The 15 minute mindfulness session is a scripted mindfulness exercise that incorporates mindfulness principles of intentionally paying attention to present-moment experience in a non-judgmental fashion.
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Expérimental: Suggestion
15 minute therapeutic suggestion session
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The 15 minute suggestion session is a scripted suggestion exercise that incorporates imagery and suggestions for changes in cognition, emotion, and body sensations.
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Comparateur actif: Psychoeducation
15 minute psychoeducation session
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The 15 minute psychoeducation session is a supportive session in which behavioral coping strategies for pain management are discussed.
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Aucune intervention: Usual Care
The usual care comparison group was comprised of patients who underwent total joint arthroplasty of the hip or knee at the same academic medical center during the study period but who did not attend Joint Academy.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Pain Intensity Numeric Rating Scale
Délai: Immediately prior to and following intervention
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Single Likert scale item ranging from 0-10, with 0 indicating no pain and 10 representing the most intense pain imaginable.
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Immediately prior to and following intervention
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Pain Unpleasantness Numeric Rating Scale
Délai: Immediately prior to and following intervention
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Single Likert scale item ranging from 0-10, with 0 indicating no pain and 10 representing the most unpleasant pain imaginable.
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Immediately prior to and following intervention
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Pain Medication Desire Numeric Rating Scale
Délai: Immediately prior to and following intervention
|
Single Likert scale item ranging from 0-10, with 0 indicating no desire for pain medication and 10 representing a strong desire for pain medication.
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Immediately prior to and following intervention
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Anxiety Numeric Rating Scale
Délai: Immediately prior to and following intervention
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Single Likert scale item ranging from 0-10, with 0 indicating no anxiety and 10 representing very anxious.
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Immediately prior to and following intervention
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Postoperative Patient Reported Outcomes Measurement Information System (PROMIS) Physical Functioning Item Bank, v2.0
Délai: During the 6 weeks prioir to surgery and at the 6-week outpatient follow-up appointment.
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The PROMIS physical functioning computer assisted test draws from a bank of 123 items all scored on a 5 point Likert scale. T-Score distributions are standardized such that a 50 represents the average (mean) for the US general population, and the standard deviation around that mean is 10 points. A high score better physical functioning. |
During the 6 weeks prioir to surgery and at the 6-week outpatient follow-up appointment.
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Nondual Awareness Dimensional Assessment - State
Délai: Immediately prior to and following intervention
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Three Likert scale item ranging from 0-30, with 0 indicating no nondual awareness and 10 representing complete nondual awareness.
Items can also be used individually.
Item one is a single Likert scale item ranging from 0-10, with 0 indicating no relational unity and 10 representing complete relational unity.
Item two is a single Likert scale item ranging from 0-10, with 0 indicating no annihilational unity and 10 representing complete annihilational unity.
Item three is a single Likert scale item ranging from 0-10, with 0 indicating no bliss and 10 representing complete bliss.
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Immediately prior to and following intervention
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Sensation Manikin Body Sensation Report
Délai: Immediately prior to and following intervention
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The ratio of pleasant to unpleasant bodily sensations reported on a sensation manikin.
Ratio scores below 1 indicate unpleasant sensations predominate in the body and ratio scores above 1 indicate pleasant scores predominate.
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Immediately prior to and following intervention
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Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Present Moment Awareness Numeric Rating Scale (Manipulation Check)
Délai: Immediately prior to and following intervention
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Single Likert scale item ranging from 0-10, with 0 indicating no awareness of the present and 10 representing complete awareness of the present moment.
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Immediately prior to and following intervention
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Decentering Numeric Rating Scale (Manipulation Check)
Délai: Immediately prior to and following intervention
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Single Likert scale item ranging from 0-10, with 0 indicating no decentering and 10 representing a completely decentered perspective.
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Immediately prior to and following intervention
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Collaborateurs et enquêteurs
Parrainer
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
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 (Réel)
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
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- IRB_00085446
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
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