Effect of Preoperative Education Based on Roy Adaptation Model

Orthopedic Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05248529
• Other study ID #: mozsoy
• Status: Completed
• Phase: N/A
• Start date: November 1, 2017
• Est. completion date: April 1, 2018

Study information

• Verified date: February 2022
• Source: Istanbul Medipol University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: April 1, 2018
• Est. primary completion date: January 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 45 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Musculoskeletal Diseases
• Orthopedic Disorder

Intervention

Other:
• Education booklet
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

Locations

Country	Name	City	State
Turkey	Yeditepe University Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul Medipol University Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight	weight in kilograms. It was used to determine the body mass index.	5 days
Primary	height	height in meters. it was used to determine the body mass index.	5 days
Primary	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.	5 days
Primary	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.	5 days
Secondary	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.	5 days
Secondary	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.	5 days