Providing Patients Realistic Expectations of Postoperative Pain (PPREOPP)
The PPREOPP Study: Providing Patients Realistic Expectations of Postoperative Pain
研究概览
详细说明
This is a prospective, randomized, single-blind study in 100 patients undergoing open colorectal surgery. If the hypothesis is confirmed, then patients who receive perioperative educational interventions to address their expectation about their postoperative pain will have improved pain-related postoperative outcomes.
Randomization and Blinding 100 eligible patients scheduled to undergo open colorectal surgery will be approached in the Center for Preoperative Assessment and Planning Clinic. At enrollment, each patient will be assigned a study number, which will match a previously prepared computer-generated list of randomization numbers to determine whether they will be in the intervention or control arm. Pre-operatively, all patients will complete an initial questionnaire. The patients in the intervention group (n=50) will, in addition to the standard pre-operative assessment, also receive pre-operative educational instruction of what to expect from a post-operative pain perspective including education material to take home.
For this study, deception will be used, with the reasoning that the patients' knowledge of the different education materials will affect their rating of the impact of the intervention on satisfaction scores.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Missouri
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Saint Louis、Missouri、美国、63110
- Washington University in St. Louis
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Age > 18 years
- Undergoing open colorectal surgery Able to understand and sign and informed consent form
Exclusion Criteria:
- Age < 18 years
- Unable to complete post-operative CMS questionnaire
- Inability to understand the English language Absolute contraindication to epidural placement (patient refusal, requiring resumption of therapeutic anticoagulation after surgery, anaphylaxis to local anesthetics, local or systemic infections, bleeding diathesis)
学习计划
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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无干预：Control
Standard preoperative assessment
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有源比较器：Education
Pre-operative education regarding post-operative pain expectations
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Participants who receive perioperative educational to address their expectation about their postoperative pain will have improved pain-related postoperative outcomes.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Does perioperative education improve satisfaction with postoperative pain control at discharge?
大体时间：Upon discharge, Day 1 - Day 7
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The satisfaction with postoperative pain control will be assessed using an initial, post-operative and discharge questionnaire of participant's pain level, medications (if any) to manage pain, the affects of that pain management, and participant satisfaction of that pain control.
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Upon discharge, Day 1 - Day 7
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合作者和调查者
调查人员
- 首席研究员：Michael Bottros, MD、Washington University School of Medicine
出版物和有用的链接
一般刊物
- Kaur H, Singh G, Singh A, Sharda G, Aggarwal S. Evolving with modern technology: Impact of incorporating audiovisual aids in preanesthetic checkup clinics on patient education and anxiety. Anesth Essays Res. 2016 Sep-Dec;10(3):502-507. doi: 10.4103/0259-1162.177187.
- Waljee J, McGlinn EP, Sears ED, Chung KC. Patient expectations and patient-reported outcomes in surgery: a systematic review. Surgery. 2014 May;155(5):799-808. doi: 10.1016/j.surg.2013.12.015. Epub 2013 Dec 16.
- Koenen P, Bathis H, Schneider MM, Frohlich M, Bouillon B, Shafizadeh S. How do we face patients' expectations in joint arthroplasty? Arch Orthop Trauma Surg. 2014 Jul;134(7):925-31. doi: 10.1007/s00402-014-2012-x. Epub 2014 May 24.
- Ghomrawi HM, Mancuso CA, Westrich GH, Marx RG, Mushlin AI; Expectations Discordance Study Group. Discordance in TKA expectations between patients and surgeons. Clin Orthop Relat Res. 2013 Jan;471(1):175-80. doi: 10.1007/s11999-012-2484-3.
- Shuldham C. A review of the impact of pre-operative education on recovery from surgery. Int J Nurs Stud. 1999 Apr;36(2):171-7. doi: 10.1016/s0020-7489(99)00010-3.
- Snyder-Ramos SA, Seintsch H, Bottiger BW, Motsch J, Martin E, Bauer M. Patient satisfaction and information gain after the preanesthetic visit: a comparison of face-to-face interview, brochure, and video. Anesth Analg. 2005 Jun;100(6):1753-1758. doi: 10.1213/01.ANE.0000153010.49776.E5.
- Noorian C, Aein F. Comparative investigation of the effectiveness of face-to-face verbal training and educational pamphlets on readiness of patients before undergoing non-emergency surgeries. J Educ Health Promot. 2015 May 19;4:45. doi: 10.4103/2277-9531.157231. eCollection 2015.
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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