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Completed

NCT Number: NCT06662981

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.

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Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sara Eleni Amprachim, Athens, Greece

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

preoparative information and education

Behavioral

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.

Primary outcomes

  1. Hip pain and functionality

    Time frame: 30 days postoperatively

    Assessed using modified Harris Hip Score (mHHS), validated in Greek, one day preoperatively and one month postoperatively

  2. Length of Hospital Stay

    Time frame: 30 days postoperatively

    Duration of hospitalization, measured in days

  3. Anxiety and Depression

    Time frame: 30 days postoperatively

    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

  4. Health-related quality of life

    Time frame: 30 days postoperatively

    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

Sponsors and collaborators

Lead sponsor

National and Kapodistrian University of Athens

Other

Registry information

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Oct 29, 2024
Registry last updated
Oct 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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