The Effect of Preoperative Information and Education in the Clinical Outcome of Total Hip Arthroplasty

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.

Study Overview

• Status: Completed
• Conditions: Total Hip Arthroplasty
• Intervention / Treatment: Behavioral: preoparative information and education

Detailed Description

A total of 100 patients will be randomized into two groups: the intervention group (n = 50) receiving standardized preoperative information and education, and the control group (n = 50) receiving standard preoperative care without a formal educational component. Postoperative outcomes, including pain, functionality, mobility, length of hospital stay (LOS), health-related quality of life, anxiety and depression will be compared between the 2 groups.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Greece
  • Athens, Greece, 15124
    • Sara Eleni Amprachim
  • Attica
    • Kifissia, Attica, Greece, 14561
      • KAT Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Exclusion criteria in the study will be patients:

• under 50 years old
• with reduced mental abilities
• with a presence of mental illness
• who have had previous hip surgery

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: preoperative education; 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.	Behavioral: preoparative information and education; 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.
No Intervention: no preoparative education (basic information); Patients will receive the standard preoperative care, which will not include formalized education beyond routine consent.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: National and Kapodistrian University of Athens

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 31, 2022
• Primary Completion (Actual): September 30, 2024
• Study Completion (Actual): October 1, 2024

Study Registration Dates

• First Submitted: September 23, 2023
• First Submitted That Met QC Criteria: October 26, 2024
• First Posted (Actual): October 29, 2024

Study Record Updates

• Last Update Posted (Actual): October 29, 2024
• Last Update Submitted That Met QC Criteria: October 26, 2024
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: total hip arthroplasty; preoperative information; preoperative education
• Other Study ID Numbers: 11000 (DAIDS ES Registry Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Patient data will be processed by the primary investigator

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No