Esplorazione delle preferenze terapeutiche dei pazienti per il dolore pelvico cronico: uno studio con metodi misti
This research is studying what things change the way people think about treatment for chronic pelvic pain (CPP). The study team is also interested in whether a web-based educational and self-management program for chronic pelvic pain changes how people think about chronic pelvic pain treatments. The program contains several different self-guided modules that include cognitive and behavioral structuring, self-administration of acupressure, engaging in physical activity, and a brief introduction to pelvic floor physical therapy techniques.
The study hypothesis is that patients with CPP will report that prior treatment experiences and most trusted source of medical information will be associated with baseline perceptions of various CPP treatment modalities.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
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Michigan
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Ann Arbor, Michigan, Stati Uniti, 48109
- University of Michigan
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-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- Have chronic pelvic pain, defined as moderate to severe pelvic pain (based on protocol) for greater or equal to(≥) 6-month duration, and is non-cyclic, occurring for at least 14 days of each month.
- Must be scheduled for a new patient visit with the Chronic Pelvic Pain and Endometriosis Referral Clinic within the Department of Obstetrics and Gynecology at the University of Michigan for treatment of chronic pelvic pain.
- Access to internet via computer or smartphone
- English-language proficiency (current version of the website is in English)
- The study team will attempt to recruit a diverse group of patients, with attention to diversity in race, ethnicity, education level, rural vs urban locality, sexual orientation, and gender identification.
Exclusion Criteria:
- Severe physical impairment precluding participating in internet-based program (for example, complete blindness or deafness)
- Prior care within the Chronic Pelvic Pain and Endometriosis Referral Clinic within the Department of Obstetrics and Gynecology at the University of Michigan for treatment of chronic pelvic pain (seen previously but meets criteria for new patient visit because > 3 year interval since last clinic visit).
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Ricerca sui servizi sanitari
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: My Pelvic Plan
This is a web-based self-guided program. |
Following the baseline interview, participants will receive a link to a web-based self-guided program and have access for two weeks "My Pelvic Plan" that combines education on several individual conditions that often contribute to CPP, and will include instruction on cognitive and behavioral restructuring, self-administration of acupressure, engaging in physical activity, and a brief introduction to pelvic floor physical therapy techniques. Subsequent to this, participants will then complete another brief questionnaire after a two-week interval. This questionnaire will focus on willingness to consider specific treatment modalities, credibility/expectancy for specific treatment modalities, and a brief measure assessing self-efficacy for managing symptoms. |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Explore factors that influence patient perceptions of treatment modalities for chronic pelvic pain
Lasso di tempo: Baseline
|
Explore prior treatment experiences, attitudes/perceptions of treatment modalities, sources of medical information. Baseline questionnaire and individual structured interview will be used. |
Baseline
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Change in self-reported interest in treatment modalities
Lasso di tempo: Baseline, 3 weeks (post baseline)
|
To evaluate whether brief exposure to a novel web-based educational and self-management program for chronic pelvic pain increases willingness to consider various treatment modalities one question will be asked. The question states are participants interested in trying six different treatment modalities and select from "yes, definitely interested", "would consider", "not sure, need to hear more about this option", or "not interested". |
Baseline, 3 weeks (post baseline)
|
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Change in credibility/expectancy questionnaire (CEQ)
Lasso di tempo: Baseline, 3 weeks (post baseline)
|
The CEQ is a self-report measure assessing the credibility and expectancy of treatment received. It consists of 6 items, 4 items with a 9-point Likert-type rating of 1 (not at all) to 5 (very much) with a scoring range of 3-27. The other 2 items are on a percentage scale from 0%-100% in increments of 10 with a scoring range of means 0-100%. Higher scores denote higher treatment credibility and expectancy. |
Baseline, 3 weeks (post baseline)
|
Collaboratori e investigatori
Sponsor
Collaboratori
Investigatori
- Investigatore principale: Sara Till, MD, University of Michigan
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Altri numeri di identificazione dello studio
- HUM00253781
- 1K23HD099283-01A1 (Sovvenzione/contratto NIH degli Stati Uniti)
Piano per i dati dei singoli partecipanti (IPD)
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