The Effect of Preoperative Information and Education in the Clinical Outcome of Total Hip Arthroplasty
1 other identifier
interventional
100
1 country
2
Brief Summary
Preoperative patient information and education is an essential aspect of modern surgical care, particularly for patients undergoing total hip arthroplasty (THA). This prospective, randomized trial aims to assess the effects of structured preoperative education and information on clinical outcomes in patients undergoing THA.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2022
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 31, 2022
CompletedFirst Submitted
Initial submission to the registry
September 23, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2024
CompletedFirst Posted
Study publicly available on registry
October 29, 2024
CompletedOctober 29, 2024
September 1, 2023
1.9 years
September 23, 2023
October 26, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Hip pain and functionality
Assessed using modified Harris Hip Score (mHHS), validated in Greek, one day preoperatively and one month postoperatively
30 days postoperatively
Length of Hospital Stay
Duration of hospitalization, measured in days
30 days postoperatively
Anxiety and Depression
Assessed using the Hospital Anxiety and Depression Scale (HADS), validated in Greek, one day preoperatively, one day before discharge from hospital, and one month postoperatively
30 days postoperatively
Health-related quality of life
Assessed using EQ-5D-5L index and EQ-5D-5L visual analog scale (VAS), validated in Greek one day preoperatively, one day before discharge from hospital, and one month postoperatively
30 days postoperatively
Study Arms (2)
preoperative education
EXPERIMENTALThe intervention will include oral and written education about the operation, nursing and active participation in self-care. The intervention will take place in 3 phases: One week before THA, one day before THA after patient admission and postoperatively, before patient discharge. After a rough description of the operation, the anatomy and functionality of the joint will be presented, underlining the necessity of the operation. Instructions for recognizing and managing potential complications will be given. Patients will be informed about the appropriate post-operative walking aids, walking style, sitting up techniques, standing-up techniques, lying down techniques and getting in and out of the car. There will be a demonstration of muscle strengthening exercises, isometric quadriceps and gluteal exercises, Patients will also be informed about the necessity of prophylactic postoperative antithrombotic and antibiotic treatment.
no preoparative education (basic information)
NO INTERVENTIONPatients will receive the standard preoperative care, which will not include formalized education beyond routine consent.
Interventions
The intervention will include oral and written education about the operation, nursing and active participation in self-care. The intervention will take place in 3 phases: One week before THA, one day before THA after patient admission and postoperatively, before patient discharge. After a rough description of the operation, the anatomy and functionality of the joint will be presented, underlining the necessity of the operation. Instructions for recognizing and managing potential complications will be given. Patients will be informed about the appropriate post-operative walking aids, walking style, sitting up techniques, standing-up techniques, lying down techniques and getting in and out of the car. There will be a demonstration of muscle strengthening exercises, isometric quadriceps and gluteal exercises, Patients will also be informed about the necessity of prophylactic postoperative antithrombotic and antibiotic treatment.
Eligibility Criteria
You may not qualify if:
- under 50 years old
- with reduced mental abilities
- with a presence of mental illness
- who have had previous hip surgery
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Sara Eleni Amprachim
Athens, Athens, 15124, Greece
KAT Hospital
Kifissia, Attica, 14561, Greece
Related Publications (1)
Amprachim SE, Vlamis J, Nikolaou VS, Pneumaticos SG. Role of Preoperative Information and Education of Patients Undergoing Total Hip Arthroplasty: A Narrative Review of the Literature. Cureus. 2024 Aug 3;16(8):e66094. doi: 10.7759/cureus.66094. eCollection 2024 Aug.
PMID: 39224727BACKGROUND
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- RN, MSc, MSc, PhD (c), General Hospital of Attica "KAT", Athens, Greece
Study Record Dates
First Submitted
September 23, 2023
First Posted
October 29, 2024
Study Start
October 31, 2022
Primary Completion
September 30, 2024
Study Completion
October 1, 2024
Last Updated
October 29, 2024
Record last verified: 2023-09
Data Sharing
- IPD Sharing
- Will not share
Patient data will be processed by the primary investigator