Effect of Preoperative Education Based on Roy Adaptation Model

February 19, 2022 updated by: Merve Ozsoy Durmaz, MSc, Istanbul Medipol University Hospital

Effect of Preoperative Education Based on Roy Adaptation Model in Patients With Hip or Knee Arthroplasty on Physical Adaptation and Mobility

This research was conducted as a randomized controlled experiment to determine the effect of the education given by the Physiological Mode of Roy Adaptation Model in patients with hip or knee arthroplasty on physical adaptation and mobility.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The research was conducted between 01.11.2017 - 01.04.2018 at the Orthopedics and Traumatology Surgery Service of a private University Hospital in Istanbul.

In the study, the number of samples to be taken; the training, the training group control group mobility scale scores between The Observer at least 5% of the study considering that would make a difference, and power 80%, α=0.05 and power analysis adopted by participants for each group were calculated and it was determined that there should be at least 27.

The sample was composed of 78 individuals 41 experimental and 37 control. Patients' physical adaptation and mobility were evaluated using the Patient Mobility Scale and Observer Mobility Scale and Physical Adaptation Assessment Form.

Randomization of the study was achieved by planning patients who met the inclusion and non-inclusion criteria for training and control groups sequentially, without dividing them into hip or knee arthroplasty. In the randomization table, those with the number 1 are assigned to the training group.

Study Type

Interventional

Enrollment (Actual)

78

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Istanbul, Turkey
        • Yeditepe University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

can read and write in Turkish A sufficient level of education to understand study procedures and training

Exclusion Criteria:

hospitalized due to fracture mental disability neurological disease undergone the same operation before received similar training before

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention group
Within 12-24 hours before the surgery, the demonstrative education was given based on 'Hip Replacement Adaptation Booklet' and 'Knee Replacement Adaptation Booklet' to the patients in the intervention group.
Hip/Knee Replacement Adaptation Booklet explains preoperative preparation, post-operative care practices, how to walk with walker, what needs to be done at home after discharge
No Intervention: Control gorup
Routine preoperative preparation training was performed to the patients in the control group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Weight
Time Frame: 5 days
weight in kilograms. It was used to determine the body mass index.
5 days
height
Time Frame: 5 days
height in meters. it was used to determine the body mass index.
5 days
Body Mass Index
Time Frame: 5 days
Body Mass Index is a simple calculation using a person's height and weight. The formula is BMI = kg/m2 where kg is a person's weight in kilograms and m2 is their height in metres squared.
5 days
Systolic and diastolic blood pressure
Time Frame: 5 days
Both systolic and diastolic blood pressure is measured in units of millimeters of mercury (mmHg). It was used to determine the blood pressure of patients before mobilization.
5 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Observer Mobility Scale
Time Frame: 5 days
1 point indicates that the activity can be performed independently without verbal warning and physical assistance, 5 points indicate that the patient cannot perform the activity independently despite the verbal warning and physical assistance. The lowest score that can be obtained from the scale is 4 and the highest score is 20.
5 days
The Patient Mobility Scale
Time Frame: 5 days
As a scale score, 1 indicates that the patient has no pain during the activity and the level of difficulty when moving is minimal, while 5 indicates that the patient's pain during the activity is unbearable and the level of difficulty is greatest. The lowest score that can be obtained from the scale is 8 and the highest score is 40.
5 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Merve Ozsoy Durmaz, Medipol University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2017

Primary Completion (Actual)

January 1, 2018

Study Completion (Actual)

April 1, 2018

Study Registration Dates

First Submitted

January 24, 2022

First Submitted That Met QC Criteria

February 9, 2022

First Posted (Actual)

February 21, 2022

Study Record Updates

Last Update Posted (Actual)

March 8, 2022

Last Update Submitted That Met QC Criteria

February 19, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

An application for publication will be submitted in 2022.

IPD Sharing Time Frame

6 months

IPD Sharing Access Criteria

studies on hip and knee arthroplasty

IPD Sharing Supporting Information Type

  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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