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Clinical Trials/NCT05346822
NCT05346822
Completed
N/A

The Effects of a Patient-specific Integrated Education Program on Pain, Perioperative Anxiety, and Functional Recovery Following Total Knee Replacement

Kaohsiung Medical University Chung-Ho Memorial Hospital1 site in 1 country70 target enrollmentSeptember 17, 2019
ConditionsKnee Arthritis

Overview

Phase
N/A
Intervention
Not specified
Conditions
Knee Arthritis
Sponsor
Kaohsiung Medical University Chung-Ho Memorial Hospital
Enrollment
70
Locations
1
Primary Endpoint
American Knee Society Scores(AKS)
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

This project is about the integrated rehabilitation program for the patients receiving total knee arthroplasty. The investigators are monitoring the WOMAC(Western Ontario and Mcmaster University Arthritis Index)/ Pain scores/Anxiety scores/Knee society scores in the treatment course between the intervention group and the control group.

Detailed Description

This is a quasi-experimental design study. The participants received total knee arthroplasty by one single surgeon in two facilities within the same medical system (Kaohsiung Medical University affiliated hospitals). The intervention groups received integrated rehabilitation program including verbal one-on-one education, personalized post-operation rehabilitation during admission and scheduled post-operation follow up by a nurse case manager. The control group received the same surgery with traditional clinical pathway by the single surgeon in another affiliated hospital. We recorded the pain scores, state-trait anxiety inventory scores, WOMAC(Western Ontario and Mcmaster Universities Arthritis Index) scores, American Knee society scores for these participants.

Registry
clinicaltrials.gov
Start Date
September 17, 2019
End Date
July 31, 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

American Knee Society Scores(AKS)

Time Frame: From admission to 3 months after surgery

The AKS ranges from 100 (normal knee function score) to 0 (worst knee function score). Higher scores mean a better outcome.

Visual Analogue Pain Score (VAS)

Time Frame: From admission to 3 months after surgery

Minimum pain intensity from 0 to Maximum of 10. Higher scores mean a higher pain intensity.

State-trait Anxiety Inventory (STAI)

Time Frame: From admission to 3 months after surgery

Peri-operative anxiety scoring system. STAI varies from a minimum score of 20 to a maximum score of 80. STAI scores are commonly classified as "no or low anxiety" (20-37), "moderate anxiety" (38-44), and "high anxiety" (45-80). Higher scores mean higher anxiety.

WOMAC (Western Ontario and Mcmaster Universities Arthritis Index)

Time Frame: From admission to 3 months after surgery

The WOMAC evaluates 3 dimensions : pain(maximal score of 20), stiffness(maximal score of 8), and physical function(maximal score of 68). Higher scores mean worse outcomes.

Study Sites (1)

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