A Prospective Cohort Study Comparing Preoperative Anxiety and One-Year Patient-Reported Outcomes Between Enhanced Recovery After Surgery and Conventional Care in Orthopedic Surgery Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 220
- 试验地点
- 1
- 主要终点
- Preoperative Anxiety (APAIS Score)
研究概览
简要总结
This study investigates whether an Enhanced Recovery After Surgery (ERAS) program can help orthopedic surgery patients feel less anxious before their operation and recover better one year after surgery, compared to conventional (standard) surgical care.
Patients who undergo orthopedic surgery, such as joint replacement, often experience significant anxiety before the operation. While ERAS programs, which combine patient education, pain management, and early mobilization, have been shown to shorten hospital stays and reduce complications, less is known about whether they also reduce preoperative anxiety and lead to better long-term outcomes reported by patients themselves.
In this prospective cohort study, patients receiving ERAS care will be compared with patients receiving conventional care. Preoperative anxiety will be measured using a validated questionnaire (APAIS). Clinical recovery during hospitalization, including length of stay, pain scores, and opioid use, will also be recorded. Patients will then be followed for one year to assess their quality of life (EQ-5D-5L) and their own impression of overall improvement (Patient Global Impression of Change).
The goal of this study is to determine whether ERAS not only improves short-term surgical recovery, but also reduces preoperative anxiety and leads to better long-term, patient-centered outcomes.
详细描述
This is a prospective, observer-blinded cohort study conducted at Hualien Tzu Chi Hospital, comparing patients who receive Enhanced Recovery After Surgery (ERAS) care with those who receive conventional perioperative care for orthopedic surgery.
Group assignment (ERAS vs. conventional care) follows the clinical care pathway naturally selected by the treating surgical team according to institutional standard practice; the study team does not intervene in treatment decisions and functions solely as an independent, blinded outcome assessor.
The ERAS pathway includes multiple evidence-based components delivered as part of routine institutional care: preoperative patient education and expectation management, shortened fasting time with preoperative carbohydrate loading, multimodal analgesia and antiemetic strategies, standardized timing for drain/catheter removal, and early postoperative mobilization with structured discharge planning. Patients in the conventional care group receive the hospital's existing standard perioperative management.
Preoperative anxiety is assessed at two time points using the Amsterdam Preoperative Anxiety and Information Scale (APAIS): a baseline measurement immediately after the patient provides informed consent for surgery, prior to any ERAS or conventional preoperative education (T0), and a follow-up measurement after hospital admission, following completion of preoperative education (ERAS or conventional), immediately before the patient enters the operating room (T1). This pre-post design allows the study to evaluate the within-subject change in anxiety attributable to the preoperative care pathway, in addition to between-group comparisons at each time point.
In-hospital clinical recovery is tracked at multiple postoperative time points (24, 48, and 72 hours, and at discharge), including length of hospital stay, postoperative opioid consumption, pain scores (NRS), time to first mobilization and ambulation, and time to catheter/drain removal.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion Criteria:
- •Age >= 20 years.
- •Hospitalized patients scheduled for elective major orthopedic surgery (such as total knee arthroplasty, total hip arthroplasty, or spinal surgery).
- •Possess sufficient language comprehension and expression skills to complete interviews and questionnaires in Mandarin, Taiwanese, Hakka, or English.
- •Agree to participate in the study and provide written informed consent.
排除标准
- •Patients requiring immediate management due to emergency or traumatic urgent surgery.
- •Diagnosed by a physician with significant cognitive impairment, delirium, or severe mental illness resulting in the inability to complete evaluation and follow-up.
- •Severe and unstable medical conditions (such as ASA-V, shock, or requiring long-term intensive care treatment).
- •Anticipated requirement for intensive care unit (ICU) admission postoperatively.
- •Concurrent participation in other clinical trials or intervention studies that would affect anxiety or functional outcomes.
- •Patients for whom follow-up up to 12 months is inconvenient or difficult during the study period.
研究组 & 干预措施
ERAS group
Patients receiving perioperative care according to the orthopedic Enhanced Recovery After Surgery (ERAS) pathway (including preoperative education, nutrition and fasting optimization, multimodal anesthesia and analgesia, and early mobilization).
干预措施: Enhanced Recovery After Surgery (ERAS) pathway (Other)
Conventional care group
Patients receiving conventional routine clinical care and standard medical orders.
干预措施: Conventional care group (Other)
结局指标
主要结局
Preoperative Anxiety (APAIS Score)
时间窗: From 1 week before surgery up to the day of admission (preoperatively).
Preoperative anxiety level measured using the Amsterdam Preoperative Anxiety and Information Scale (APAIS) anxiety subscale, which ranges from 4 to 20. Higher scores indicate higher levels of anxiety.
次要结局
- 1-Year Patient-Reported Quality of Life (EQ-5D-5L Index)(At 12 months postoperatively.)
研究者
Wu Jing-Ru
Surgical Specialist Nurse, Department of Urology, Hualien Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
Buddhist Tzu Chi General Hospital