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

NCT07706244 | Recruiting

• 1 other identifier: IRB114-217-B
• Study Type: observational
• Target: 220
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Preoperative Anxiety; Orthopedic Surgery; Patient Reported Outcome (PRO)

Keywords

Enhanced Recovery After Surgery; ERAS; APAIS; EQ-5D-5L; Patient Global Impression of Change; Quality of Life; Cohort Study; Perioperative Care

Outcome Measures

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.

  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)

  At 12 months postoperatively.

Other Outcomes (1)

• Length of Hospital Stay (LOS)

  From the day of surgery to hospital discharge (average of 3-7 days).

Study Arms (2)

ERAS group

Patients receiving perioperative care according to the orthopedic Enhanced Recovery After Surgery (ERAS) pathway (including preoperative education, nutrition and fasting optimization, multimodal anesthesia and analgesia, and early mobilization).

Other: Enhanced Recovery After Surgery (ERAS) pathway

Conventional care group

Patients receiving conventional routine clinical care and standard medical orders.

Other: Conventional care group

Interventions

Enhanced Recovery After Surgery (ERAS) pathway OTHER

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).

ERAS group

Conventional care group OTHER

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.

Conventional care group

Eligibility Criteria

• Age: 20 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Buddhist Tzu Chi General Hospital: lead

Study Sites (1)

Hualien Tzu Chi Hospital

Hualien City, Hualien County, 970, Taiwan

RECRUITING

MeSH Terms

Interventions

Enhanced Recovery After Surgery

Intervention Hierarchy (Ancestors)

Perioperative Care; Surgical Procedures, Operative

Central Study Contacts

Jing-Ru Wu, MSN, RN;PhD Student

CONTACT

+886-922095954; 113330117@gms.tcu.edu.tw

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Surgical Specialist Nurse, Department of Urology, Hualien Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

Study Record Dates

• First Submitted: July 11, 2026
• First Posted: July 15, 2026
• Study Start: November 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: July 17, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)