Guided IMagery and Patient Satisfaction (GIMPS) Following Urogynecological Surgery (GIMPS)
Guided IMagery and Patient Satisfaction Following Urogynecological Surgery
調査の概要
詳細な説明
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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Illinois
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Maywood、Illinois、アメリカ、60153
- Loyola University Medical Center
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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:
- routine vaginal or laparoscopic surgery for pelvic organ prolapse planned ≥ 1 week from enrollment
- a planned overnight hospital stay
- commitment to listen to a 15 minute audio Compact Disc daily
- proficiency in English.
Exclusion Criteria:
- Not having routine vaginal or laparoscopic surgery for pelvic organ prolapse planned ≥ 1 week from enrollment
- Not a planned overnight hospital stay
- Unable to commitment to listen to a 15 minute audio Compact Disc daily
- Not proficiency in English.
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:支持療法
- 割り当て:ランダム化
- 介入モデル:並列代入
- 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 |
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アクティブコンパレータ:Guided IMagery (GIM)
If randomized to GIM, they will then be given an audio Compact Disc.
Patients will be instructed to listen to the recording least once per day in a calm location during the week leading up to surgery.
They will then be seen prior to surgery in the surgical waiting area where they will evaluated for anxiety, preparedness and study compliance.
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It's a program of directed thoughts and suggestions that guide your imagination to a relaxed and focused state.
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介入なし:Standard of Care (SOC)
Each participant will complete a baseline set of questionnaires. The Pelvic Floor Distress Inventory (PFDI) is a 20 question self-administered questionnaire on the presence and both of pelvic floor symptoms . The Pelvic Organ Prolapse Quantification System (POPQ) measures the topography of the vagina and is considered to be gold standard for quantifying prolapse . The State-Trait Anxiety Inventory (STAI) has been used extensively in research and clinical practice since its introduction in 1966 and is the most widely cited measure of anxiety. New measurements at the 6-week follow-up appointment will include the Patient Global Impression of Improvement (PGII), and a postoperative questionnaire eliciting overall satisfaction and development of new pelvic 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 |
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Change in patient satisfaction with urogynecological surgery when using GIM (questionnaire)
時間枠:6 weeks
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Women will report their satisfaction with their surgical experience 6 weeks after surgery using a 10-point Likert scale.
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6 weeks
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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Change in patient sense of preparedness when using GIM (questionnaire)
時間枠:6 weeks
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Preparedness will be measured at baseline, day of surgery, and 6 weeks after surgery to determine how GIM affected patient preparedness.
It will be measured using a 10-point Likert scale
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6 weeks
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Change in patient anxiety about surgery when using GIM (questionnaire)
時間枠:6 week
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Patient anxiety will be measured at baseline, day of surgery and at 6 weeks post op to determine how GIM affected anxiety.
It will be measured using the State-Trait Anxiety Inventory (STAI), which has been used extensively in research and clinical practice since its introduction in 1966 and is the most widely cited measure of anxiety.
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6 week
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協力者と研究者
スポンサー
捜査官
- 主任研究者:Elizabeth Mueller, MD、Loyola University
出版物と役立つリンク
一般刊行物
- Barber MD, Walters MD, Bump RC. Short forms of two condition-specific quality-of-life questionnaires for women with pelvic floor disorders (PFDI-20 and PFIQ-7). Am J Obstet Gynecol. 2005 Jul;193(1):103-13. doi: 10.1016/j.ajog.2004.12.025.
- Bump RC, Mattiasson A, Bo K, Brubaker LP, DeLancey JO, Klarskov P, Shull BL, Smith AR. The standardization of terminology of female pelvic organ prolapse and pelvic floor dysfunction. Am J Obstet Gynecol. 1996 Jul;175(1):10-7. doi: 10.1016/s0002-9378(96)70243-0.
- Holden-Lund C. Effects of relaxation with guided imagery on surgical stress and wound healing. Res Nurs Health. 1988 Aug;11(4):235-44. doi: 10.1002/nur.4770110405.
- Elkadry EA, Kenton KS, FitzGerald MP, Shott S, Brubaker L. Patient-selected goals: a new perspective on surgical outcome. Am J Obstet Gynecol. 2003 Dec;189(6):1551-7; discussion 1557-8. doi: 10.1016/s0002-9378(03)00932-3.
- Halpin LS, Speir AM, CapoBianco P, Barnett SD. Guided imagery in cardiac surgery. Outcomes Manag. 2002 Jul-Sep;6(3):132-7.
- McKinney CH, Antoni MH, Kumar M, Tims FC, McCabe PM. Effects of guided imagery and music (GIM) therapy on mood and cortisol in healthy adults. Health Psychol. 1997 Jul;16(4):390-400. doi: 10.1037//0278-6133.16.4.390.
- 1. Utay, J.; Miller, M. "Guided imagery as an effective therapeutic technique: a brief review of its history and efficacy research." Journal of Instructional Psychology, March 2006.
- Burns DS. The effect of the bonny method of guided imagery and music on the mood and life quality of cancer patients. J Music Ther. 2001 Spring;38(1):51-65. doi: 10.1093/jmt/38.1.51.
- Walker LG, Walker MB, Ogston K, Heys SD, Ah-See AK, Miller ID, Hutcheon AW, Sarkar TK, Eremin O. Psychological, clinical and pathological effects of relaxation training and guided imagery during primary chemotherapy. Br J Cancer. 1999 Apr;80(1-2):262-8. doi: 10.1038/sj.bjc.6690349.
- Fournier D, Boccara AC, Badoz J. Photothermal deflection Fourier transform spectroscopy: a tool for high-sensitivity absorption and dichroism measurements. Appl Opt. 1982 Jan 1;21(1):74-6. doi: 10.1364/AO.21.000074.
- 12. Spielberger, C.D., et al. State-Trait Anxiety Inventory (preliminary Test manual, Form B) Tallahassee, Florida: Florida State University, 1967
- Smith RC, Lay CD. State and trait anxiety: an annotated bibliography. Psychol Rep. 1974 Apr;34(2):519-94. No abstract available.
- Pham T, Kenton K, Mueller E, Brubaker L. New pelvic symptoms are common after reconstructive pelvic surgery. Am J Obstet Gynecol. 2009 Jan;200(1):88.e1-5. doi: 10.1016/j.ajog.2008.08.010. Epub 2008 Oct 9.
研究記録日
主要日程の研究
研究開始
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 (見積もり)
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
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?
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。
Guided IMagery (GIM)の臨床試験
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Zuyderland Medisch Centrum積極的、募集していない上肢骨折 | 橈骨遠位端骨折 | 上腕骨の近位端の骨折 | 上肢骨折オランダ
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Orthofix s.r.l.完了関節疾患 | ゲン・ヴァルム | Genu Valgum | 膝の変形 | 足首の変形 | 長さの不平等、脚 | 不一致の長さ;先天性 | 四肢の変形イタリア
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Massachusetts General HospitalNational Institute on Aging (NIA)募集