Preoperative AnxietyERAS-APONCT07706244
Preoperative Anxiety and One-year Patient-reported Outcomes in Orthopedic Surgery Patients Receiving Enhanced Recovery After Surgery or Conventional Care
An observational study of Preoperative Anxiety and Orthopedic Surgery, run by Buddhist Tzu Chi General Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 100 years
- Conditions the study is for
- Preoperative Anxiety, Orthopedic Surgery, Patient Reported Outcome (PRO)
- What is being tested?
- Enhanced Recovery After Surgery (ERAS) pathway and Conventional care group
- Type of treatment
- Pill or oral medicine
- How many people
- 220 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Nov 2025to Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
Hualien Tzu Chi Hospital
Hualien City, Hualien County, 970
About this study
Official title: 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
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.
Read more
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.
Read the detailed description
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.
- Being tested
- Enhanced Recovery After Surgery (ERAS) pathway, Conventional care group
- Keywords
- Enhanced Recovery After Surgery, ERAS, APAIS, EQ-5D-5L, Patient Global Impression of Change, Quality of Life, Cohort Study, Perioperative Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced Recovery After Surgery (ERAS) pathwayOther
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 groupOther
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.
| Study group | Role | What they receive |
|---|---|---|
| ERAS group | 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. Receives: Other: Enhanced Recovery After Surgery (ERAS) pathway | |
| Conventional care group | 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. Receives: Other: Conventional care group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: End of surgery is defined as completion of wound closure; time is rounded to the nearest hour.
Secondary outcomes (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
Measured: 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.
Measured: At 3, 6, 9, and 12 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2026
- Study start1 Nov 2025
- Primary completion1 Nov 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preoperative AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Buddhist Tzu Chi General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wu Jing-Ru, Buddhist Tzu Chi General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07706244
- Sponsor's protocol ID
- IRB114-217-B
- Other IDs
- IRB114-217-B
- Acronym
- ERAS-APO
- Status last verified
- Oct 2026
- First submitted
- 11 Jul 2026
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07706244
- Acronym / sponsor ID
- ERAS-APO / IRB114-217-B
- Keywords
- Enhanced Recovery After Surgery, ERAS, APAIS, EQ-5D-5L, Patient Global Impression of Change, Quality of Life, Cohort Study, Perioperative Care
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Buddhist Tzu Chi General HospitalUniversity, hospital or other
- Study start
- 1 Nov 2025 (actual)
- Primary completion
- 1 Nov 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 15 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ERAS group | – | Other: Enhanced Recovery After Surgery (ERAS) pathwayParticipants 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. |
| Conventional care group | – | Other: Conventional care groupParticipants 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. |
Who may qualify
- Ages
- 20 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Enhanced Recovery After Surgery (ERAS) pathwayA 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). | Other | ERAS group |
| Conventional care groupRoutine 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. | Other | Conventional care group |
Primary outcome
Preoperative Anxiety (APAIS Score)
Time frame: Approximately 1 week before surgery (T0) and on the day of surgery, immediately before induction of anesthesia (T1)
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.
1-Year Patient-Reported Quality of Life (EQ-5D-5L Index)
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.
EQ-VAS Self-Rated Health Score
Time frame: At 3, 6, 9, and 12 months after surgery
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 to First Out-of-Bed Mobilization
Time frame: End of surgery is defined as completion of wound closure; time is rounded to the nearest hour.
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.
2 secondary outcomes
Unplanned Hospital Readmission Within 90 Days
Time frame: Within 90 days after surgery
Patient Global Impression of Change (PGIC)
Time frame: At 3, 6, 9, and 12 months after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Preoperative Anxiety and Orthopedic Surgery, run by Buddhist Tzu Chi General Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jing-Ru Wu, MSN, RN;PhD Student (+886-922095954, 113330117@gms.tcu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Preoperative Anxiety (APAIS Score) (time frame: Approximately 1 week before surgery (T0) and on the day of surgery, immediately before induction of anesthesia (T1)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026.