NCT06662981

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2022

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 31, 2022

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

September 23, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2024

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2024

Completed
28 days until next milestone

First Posted

Study publicly available on registry

October 29, 2024

Completed
Last Updated

October 29, 2024

Status Verified

September 1, 2023

Enrollment Period

1.9 years

First QC Date

September 23, 2023

Last Update Submit

October 26, 2024

Conditions

Keywords

preoperative informationpreoperative educationtotal hip arthroplasty

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

EXPERIMENTAL

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

no preoparative education (basic information)

NO INTERVENTION

Patients 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.

preoperative education

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

KAT Hospital

Kifissia, Attica, 14561, Greece

Location

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

Educational Status

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation Characteristics

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

Locations