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Effect of Preoperative Education Based on Roy Adaptation Model

Primary Purpose

Orthopedic Disorder

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Education booklet
Sponsored by
Istanbul Medipol University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Orthopedic Disorder focused on measuring Roy Adaptation Model, hip arthroplasty, knee arthroplasty, physical adaptation, preoperative education

Eligibility Criteria

45 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Yeditepe University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention group

Control gorup

Arm Description

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.

Routine preoperative preparation training was performed to the patients in the control group.

Outcomes

Primary Outcome Measures

Weight
weight in kilograms. It was used to determine the body mass index.
height
height in meters. it was used to determine the body mass index.
Body Mass Index
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.
Systolic and diastolic blood pressure
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.

Secondary Outcome Measures

The Observer Mobility Scale
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.
The Patient Mobility Scale
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.

Full Information

First Posted
January 24, 2022
Last Updated
February 19, 2022
Sponsor
Istanbul Medipol University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05248529
Brief Title
Effect of Preoperative Education Based on Roy Adaptation Model
Official Title
Effect of Preoperative Education Based on Roy Adaptation Model in Patients With Hip or Knee Arthroplasty on Physical Adaptation and Mobility
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
November 1, 2017 (Actual)
Primary Completion Date
January 1, 2018 (Actual)
Study Completion Date
April 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul Medipol University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Orthopedic Disorder
Keywords
Roy Adaptation Model, hip arthroplasty, knee arthroplasty, physical adaptation, preoperative education

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The sample was composed of 78 individuals 41 experimental and 37 control. The intervention group was given practical training in accordance with the adaptation booklet prepared by the researcher. Patients' physical adaptation and mobility were evaluated using the Patient Mobility Scale and Observer Mobility Scale and Physical Adaptation Assesment Form. Data of the control and intervention groups were collected two times: preoperative and within 12 hours before the discharge.
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
78 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control gorup
Arm Type
No Intervention
Arm Description
Routine preoperative preparation training was performed to the patients in the control group.
Intervention Type
Other
Intervention Name(s)
Education booklet
Intervention Description
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
Primary Outcome Measure Information:
Title
Weight
Description
weight in kilograms. It was used to determine the body mass index.
Time Frame
5 days
Title
height
Description
height in meters. it was used to determine the body mass index.
Time Frame
5 days
Title
Body Mass Index
Description
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.
Time Frame
5 days
Title
Systolic and diastolic blood pressure
Description
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.
Time Frame
5 days
Secondary Outcome Measure Information:
Title
The Observer Mobility Scale
Description
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.
Time Frame
5 days
Title
The Patient Mobility Scale
Description
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.
Time Frame
5 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Merve Ozsoy Durmaz
Organizational Affiliation
Medipol University
Official's Role
Study Director
Facility Information:
Facility Name
Yeditepe University Hospital
City
Istanbul
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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

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Effect of Preoperative Education Based on Roy Adaptation Model

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