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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age20-100
SponsorBuddhist Tzu Chi General Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial population

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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Enhanced Recovery After Surgery (ERAS) pathway

    Other intervention

    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).

  • Conventional care group

    Other intervention

    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.

Treatment groups

220 Participants
are divided into 2 treatment groups
Group A: ERAS group1 intervention
Group B: Conventional care group1 intervention

Trial outcomes

Primary outcomes

1

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
From 1 week before surgery up to the day of admission (preoperatively).

Secondary outcomes

1

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.
2

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
3

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
4

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

Other outcomes

1

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).
2

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
3

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
From the end of surgery until first out-of-bed mobilization during the hospital stay
4

Foley Catheter Indwelling Time

Duration of indwelling urinary (Foley) catheterization, measured in hours from catheter placement to removal. Shorter times indicate earlier catheter removal.

Time frame
From catheter placement until removal during the hospital stay

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