The Effect of an Individualized Education Intervention on Pain Following Inguinal Hernia Repair Surgery (HREI)
The Effect of an Individualized Education Intervention Versus Usual Care on Pain Following Ambulatory Inguinal Hernia Repair
Pain after inguinal hernia repair surgery is common with more than 50% of patients reporting moderate to severe acute pain following surgery. Analgesics are helpful in managing this pain but patients can be reluctant to take analgesics due to potential adverse effects such as nausea, vomiting or constipation. Patients may also be concerned about addiction to analgesics or they may believe that experiencing moderate to severe pain after surgery is to be expected.
The purpose of this study is to investigate the impact of an individualized education program regarding pain and management of adverse effects on pain after inguinal hernia repair surgery.
研究概览
详细说明
There is clear evidence that patients who have undergone ambulatory inguinal hernia (IHR) repair have significant pain following surgery. Inguinal hernia repair has been identified as one of the most painful ambulatory surgery procedures, with 98% of patients reporting pain 24 hours following IHR surgery, and 54% of patients experiencing moderate to severe pain in the first 72 hours. Despite experiencing continued pain, patients do not always take the prescribed analgesics. Analgesics are helpful in managing post-operative pain but may have adverse effects, including nausea, vomiting or constipation, which are often not managed. Almost half of all patients who undergo ambulatory surgery experience these adverse effects with 45% experiencing constipation and 46% experiencing nausea and/or vomiting in the first 48 hours after surgery.
As well, patients may have concerns about addiction, or asking for help to manage their pain and may believe that moderate to severe pain is to be expected, contributes to healing and therefore is to be tolerated following surgery. Patients are expected to manage this pain and adverse effects of analgesics at home. Minimal research has been found regarding interventions to manage pain following ambulatory surgery, and none found specifically for patients undergoing inguinal hernia repair.
The purpose of this trial is to investigate the impact of an individualized pre-operative pain education intervention that includes a booklet with telephone support pre-operatively and after discharge home versus usual care for patients having IHR surgery. The primary outcome will be worst pain on movement in the past 24 hours and the secondary outcomes will be pain related interference, pain quality, analgesic use and adverse effects, and patient satisfaction and concerns with pain management.
研究类型
注册 (实际的)
阶段
- 第一阶段早期
联系人和位置
学习地点
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Ontario
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Toronto、Ontario、加拿大、M5B 1W8
- St. Michael's Hospital
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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:
- male
- able to speak, read and understand English,
- have telephone access.
- are scheduled for a unilateral inguinal hernia repair.
Exclusion Criteria:
- patients scheduled for a repeat IHR on the same surgical side
- patients who have emergency surgery.
- patients undergoing bilateral inguinal hernia repair.
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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实验性的:个性化教育
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The intervention consists of written information in the form of a booklet, an individualized face to face education session and two telephone support calls regarding post-discharge pain management, adverse effects of analgesics and common concerns about asking for help with pain.Participants in the intervention group will also receive two telephone support calls.
The purpose of the telephone support calls is to readdress the information that patients received in the booklet and to clarify concerns regarding post-operative pain management that were discussed during the individualized education session.
其他名称:
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无干预:Usual care
Patients undergoing elective inguinal hernia repair attend the pre-admission clinic no later than one week prior to surgery.
During this visit they receive one-on-one pre-operative education from a registered nurse.
It includes both verbal and written information.
Verbal information provided to patients includes procedural information such as the admission process, and post-operative care in the post-anaesthetic care uni and day surgery unit.
Post-discharge pain management information is minimal and consists of direction to not wait until the pain is severe before taking prescribed analgesics.
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研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
|---|---|
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The primary outcome measure is pain intensity using a 0 to 10 numeric rating scale.
大体时间:Second post-operative day
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Second post-operative day
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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Secondary measures include: quality of pain, pain related interference, analgesic use, prevalence and intensity of adverse effects of analgesics, patient concerns regarding pain management, and adequacy of post-discharge information.
大体时间:7 days after surgery
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7 days after surgery
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合作者和调查者
调查人员
- 首席研究员:Judy Watt-Watson, RN, PhD、University of Toronto
研究记录日期
研究主要日期
学习开始
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 (估计)
研究记录更新
最后更新发布 (估计)
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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