Hualien Tzu Chi Hospital
Hualien City, Hualien County, 970, Taiwan
Location status: Recruiting
NCT Number: NCT07706244
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.
Interested in participating?
Request Info20 year–100 year
All sexes
Observational
Hualien City, Hualien County, 970, Taiwan
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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).
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.
Time frame: 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.
Time frame: At 12 months postoperatively.
Long-term health-related quality of life evaluated using the EQ-5D-5L traditional Chinese version for Taiwan. The utility index will be calculated to assess patient-reported outcomes. The EQ-5D-5L utility index ranges from -0.016 to 1, where higher scores indicate a better health-related quality of life.
Time frame: From the day of surgery to hospital discharge (average of 3-7 days).
The total number of days spent in the hospital, calculated from the date of surgery to the date of discharge.
Contact information is provided by the study sponsor or research team.
Buddhist Tzu Chi General Hospital
Other
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
Acronym: ERAS-APO
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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