An observational study in Preoperative Anxiety, Orthopedic Surgery and Patient Reported Outcome (PRO), sponsored by Buddhist Tzu Chi General Hospital. Recruiting at 1 site in Taiwan. Open to participants aged 20 Years to 100 Years. Per ClinicalTrials.gov, last updated 2026-11-02.
Sponsored by Buddhist Tzu Chi General Hospital · Observational
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.
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.
Buddhist Tzu Chi General Hospital is the lead sponsor of 88 studies on the registry; 20 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
The study population consists of hospitalized patients aged 20 years or older who are scheduled for elective major orthopedic surgery (such as total knee arthroplasty, total hip arthroplasty, or spinal surgery) at Hualien Tzu Chi Hospital.
Inclusion Criteria:
Inclusion Criteria:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants who selected the ERAS-based preoperative optimization pathway as part of routine clinical care after receiving information about the available perioperative care pathways from their treating surgical team. The research team did not participate in the selection of the clinical care pathway.
Other: Enhanced Recovery After Surgery (ERAS) pathway
Participants who selected conventional care as part of routine clinical care after receiving information about the available perioperative care pathways from their treating surgical team. The research team did not participate in the selection of the clinical care pathway.
Other: Conventional care group
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.
Preoperative Anxiety (APAIS Score)
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: Approximately 1 week before surgery (T0) and on the day of surgery, immediately before induction of anesthesia (T1)
1-Year Patient-Reported Quality of Life (EQ-5D-5L Index)
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: At 12 months postoperatively.
EQ-VAS Self-Rated Health Score
Participant's self-rated health on the EQ-5D visual analogue scale (EQ-VAS), a vertical scale from 0 (worst health imaginable) to 100 (best health imaginable). Higher scores indicate better self-rated health.
Time frame: At 3, 6, 9, and 12 months after surgery
Time to First Out-of-Bed Mobilization
Time from the end of surgery to the first time the participant stands with both feet on the floor and leaves the bed, recorded in hours. Shorter times indicate earlier mobilization.
Time frame: End of surgery is defined as completion of wound closure; time is rounded to the nearest hour.
Unplanned Hospital Readmission Within 90 Days
Number of participants with an unplanned hospital readmission within 90 days after surgery, as documented in the medical record. Time Frame: Within 90 days after surgery
Time frame: Within 90 days after surgery
Patient Global Impression of Change (PGIC)
Participant-rated overall change in condition since surgery on the 7-point Patient Global Impression of Change (PGIC) scale: 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, 7 = very much worse. Lower scores indicate greater improvement.
Time frame: At 3, 6, 9, and 12 months after surgery
Length of Hospital Stay (LOS)
The total number of days spent in the hospital, calculated from the date of surgery to the date of discharge.
Time frame: From the day of surgery to hospital discharge (average of 3-7 days).
Incidence of Postoperative Complications
Number of participants with at least one postoperative complication, defined as any of the following: deep vein thrombosis, surgical site infection, prosthetic dislocation, hematoma, wound dehiscence, periprosthetic joint infection, or other complications documented in the medical record. Each complication is recorded as present (yes) or absent (no) for each participant. Participants with one or more complications are counted once. Individual complication types will also be reported descriptively. Time Frame: Within 90 days after surgery
Time frame: Within 90 days after surgery
Time to Foley Catheter Removal
Time from the end of surgery (completion of wound closure) to removal of the indwelling urinary (Foley) catheter, as documented in the nursing record, measured in hours and rounded to the nearest hour. Participants in whom no catheter was placed are recorded as 0 hours. Shorter times indicate earlier catheter removal.
Time frame: From the end of surgery until catheter removal during the hospital stay
Time to Surgical Drain Removal
Time from the end of surgery (completion of wound closure) to removal of the surgical wound drain, as documented in the nursing record, measured in hours and rounded to the nearest hour. Participants in whom no drain was placed are recorded as 0 hours. Shorter times indicate earlier drain removal.
Time frame: From the end of surgery until drain removal during the hospital stay
Postoperative Pain Intensity (NRS)
Postoperative pain intensity at rest, rated by the participant on the 0-10 Numeric Rating Scale (NRS), where 0 = no pain and 10 = worst pain imaginable, taken from the routine ward pain assessment closest to each time point. Higher scores indicate greater pain. Scores are compared between groups at each time point.
Time frame: At 24, 48, and 72 hours after the end of surgery
Cumulative Postoperative Opioid Consumption
Total opioid analgesic consumption from return to the ward (discharge from the post-anesthesia care unit) until hospital discharge, excluding intraoperative and PACU administration. Opioids given (oral tramadol/acetaminophen \[Tramacet\], intramuscular morphine, and nalbuphine injection) are converted to oral morphine milligram equivalents (MME, mg) using standard conversion factors (tramadol x 0.2; parenteral morphine and nalbuphine x 3) and summed into a single cumulative value per participant. Lower values indicate less opioid use.
Time frame: From return to the ward after post-anesthesia care unit discharge until hospital discharge (an average of 5 days)
Lower-Extremity Muscle Strength (MMT Total Score)
Muscle strength of the operated limb assessed by Manual Muscle Testing (MMT). The hip, knee, and ankle are each graded 0-5 and summed into one total score (range 0-15). Higher scores indicate greater muscle strength.
Time frame: At 72 hours after surgery
Active Range of Motion of the Operated Joint
Active range of motion of the operated joint measured in degrees: hip flexion for total hip arthroplasty and knee flexion for total knee arthroplasty. Higher values indicate greater range of motion.
Time frame: At 72 hours after surgery
Patient Satisfaction
Participant satisfaction with perioperative care rated on a 5-point scale: 1 = very dissatisfied, 2 = dissatisfied, 3 = neutral, 4 = satisfied, 5 = very satisfied. Higher scores indicate greater satisfaction.
Time frame: At hospital discharge
Plan to share: No — Individual participant data will not be shared outside the research team to ensure strict data confidentiality and protection of personal privacy, as approved by the Institutional Review Board.
No publications or documents are linked to this record.
Started Nov 2025 (actual). Primary completion is estimated for Nov 2027, 24 months after the start.
Primary completion moved once since we started tracking on Sep 25, 2026: Dec 2026 → Nov 2027, on Oct 1, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Buddhist Tzu Chi General Hospital