慢性骨盤痛に対する患者の治療の好みを探る：混合法研究
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.
調査の概要
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
-
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Michigan
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Ann Arbor、Michigan、アメリカ、48109
- University of Michigan
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-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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).
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：ヘルスサービス研究
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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. |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Explore factors that influence patient perceptions of treatment modalities for chronic pelvic pain
時間枠：Baseline
|
Explore prior treatment experiences, attitudes/perceptions of treatment modalities, sources of medical information. Baseline questionnaire and individual structured interview will be used. |
Baseline
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in self-reported interest in treatment modalities
時間枠：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)
時間枠：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)
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Sara Till, MD、University of Michigan
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
- HUM00253781
- 1K23HD099283-01A1 (米国 NIH グラント/契約)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。