Preoperative Anxiety and One-year Patient-reported Outcomes in Orthopedic Surgery Patients Receiving Enhanced Recovery After Surgery or Conventional Care
Recruiting · NCT07706244 · Observational (researchers observe without assigning treatment)
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Where it is running
1 location listed.
- Hualien Tzu Chi Hospital - Hualien City, Hualien County, Taiwan