Preoperative Anxiety and One-year Patient-reported Outcomes in Orthopedic Surgery Patients Receiving Enhanced Recovery After Surgery or Conventional Care

Официальное название

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

Обзор

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.

Подробное описание

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.

Patients are followed for one year after surgery to assess patient-reported outcomes, including health-related quality of life (EQ-5D-5L) and the Patient Global Impression of Change (PGIC), in order to evaluate whether differences observed in preoperative psychological status and short-term clinical recovery translate into sustained, patient-centered benefits over the long term.

Given the non-randomized, naturalistic allocation of patients to care pathways, statistical analyses will account for baseline differences between groups using multivariable adjustment and generalized estimating equations (GEE) for repeated measures over time.

Вмешательства

• Другое Enhanced Recovery After Surgery (ERAS) pathway
  A standardized, multidisciplinary perioperative care pathway including standardized preoperative education, nutrition and fasting optimization (shortened fasting time with preoperative carbohydrate drinks), multimodal anesthesia and analgesia (prioritizing non-opioid medications and nerve blocks), and early mobilization (encouraging mobilization within hours postoperatively, early oral intake, and early catheter removal).
• Другое Conventional care group
  Routine perioperative clinical care based on conventional medical orders. It primarily includes conventional routing education, strict fasting from midnight before surgery, and reliance on opioid medications via patient-controlled analgesia (PCA) as the primary method for postoperative pain management. Postoperative mobilization and oral intake are guided later based on patient tolerance and routine medical orders.

Первичные конечные точки

• Preoperative Anxiety (APAIS Score) [Срок оценки: From 1 week before surgery up to the day of admission (preoperatively).]

Вторичные конечные точки (1)

• 1-Year Patient-Reported Quality of Life (EQ-5D-5L Index) [Срок оценки: At 12 months postoperatively.]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Тайвань · 1 центр

• Hualien Tzu Chi Hospital — Hualien City

Идентификаторы

NCT: NCT07706244 · IRB114-217-B · IRB114-217-B

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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