The Effect of Mobile-based Education and Exercise Program Given to Patients With Total Knee Replacement Surgery

NCT05187065 | Completed

• 1 other identifier: A-KARA-001
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

Brief Summary

Total knee replacement (TDP) surgery is recognized as an effective surgical option for patients who develop moderate to severe osteoarthritis of the knee. Before, during and after TDP surgery, patients experience physical, psychological and social problems. After TDP surgery, patients may experience problems such as dependency and sleep problems in their daily living activities. Patients who have sleep problems, who cannot rest enough, become tired and experience anxiety as a result. It has been stated that the education given to the patients in the preoperative period reduces anxiety and analgesic needs and increases satisfaction. Progressive relaxation exercises in patients It has been shown to be effective in reducing symptoms such as anxiety, pain and fatigue. With the widespread use of mobile technologies, a rapid development is observed in mobile health applications and it is thought that its use in the field of health will provide great benefits to nursing services. This study is of the randomized controlled experimental type. During the application process, a mobile-based training and exercise program will be applied to the patients in the experimental group. As the education content, information about pre- and post-operative information and video-supported training content that will guide the patients with voice commands about the exercises that the patients will do before the surgery will be included in the mobile application. With the implementation of this program, continuity will be ensured by meeting the information needs of the patients before and after the surgery, and by performing progressive relaxation and knee exercises correctly and regularly. With the use of this mobile application, it is aimed to increase the physical functions of the patients by reducing the level of anxiety and fear of movement.

Conditions

Replacement, Knee

Keywords

Mobile based application; Progressive relaxation exercise; Knee exercise; Kinesiophobia; Patient Education; Physical Function; Sleep Quality; Pain; Nursing

Outcome Measures

Primary Outcomes (6)

• State-Trait Anxiety Scale

  The scale consists of two parts, a 20-item "state anxiety form" designed to determine what is felt at the moment, and a 20-item "trait anxiety form" designed to determine what is felt in general. It is a four-degree scale ranging from "Not at all" to "Totally". Scores range from 20 (low anxiety) to 80 (high anxiety).

  4 weeks

• Tampa Scale for Kinesiophobia

  The scale consists of 17 items. The scale is a 4-point Likert type (1 = I strongly disagree, 4 = I completely agree) is used. The total score varies between 17-68. A high score on the scale indicates knesiophobia.

  4 weeks

• Knee injury and osteoarthritis outcome score-physical function short-form

  The KOOS-PS scale consists of seven items. The items are intended to measure the degree of functionality of normal daily activities and more challenging activities. Each item scores between 0 "no difficulty" and 4 "very severe difficulty". The raw score is the sum of the scores given to these seven questions and ranges from 0 to 28. Higher scores indicate worse physical function.

  4 weeks

• Visual Analog Scale

  The Visual Analog Scale is a widely used scale for the assessment of pain in patients. The patient marks his or her own pain on a 10 cm ruler with the words 'no pain' on one end and 'unbearable pain' on the other end.

  4 weeks

• Visual Analog Sleep Scale

  This Visual Analog Sleep Scale measures the sleep quality of individuals. Each item in the scale is evaluated on a chart between 0 (left end) and 100 (right end) using the visual comparison technique. Scale scoring ranges from 0 to 1000. An increase in the score obtained from the scale indicates a decrease in sleep quality.

  4 weeks

• The Turkish Version of the Computer System Usability Questionnaire-Short Version

  This questionnaire evaluates the usability of a software system with 13 items. Each item is scored as 1 (Strongly agree) - 7 (Strongly disagree).

  4 weeks

Study Arms (2)

Mobile-based education and exercise program

EXPERIMENTAL

Mobile-based education and progressive relaxation and knee exercise program will be applied to the patients in the experimental group.

Other: The mobile-based education and exercise program

Standard of care

NO INTERVENTION

Mobile-based education and progressive relaxation and knee exercise program will not be applied to the patients in the control group, and the clinical routine will be maintained.

Interventions

The mobile-based education and exercise program OTHER

Starting from the preoperative period, mobile-based patient education, progressive relaxation exercise and knee exercise program will be applied to the patient as a whole. Mobile-based education will include pre-operative and discharge education. The patient will be given a progressive relaxation exercise with the support of the mobile application and the exercises included in the knee exercise program that should be done after the surgery will be shown. Progressive relaxation exercises will be applied twice a day in the afternoon and evening. Postoperative knee exercises will be performed 3 to 5 times a day, depending on the type of exercise. These exercises will be continued regularly for up to 4 weeks after discharge.

Mobile-based education and exercise program

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who were decided to undergo total knee replacement surgery with the diagnosis of osteoarthritis,
• Patients who will undergo elective surgery
• Patients who will undergo unilateral total knee replacement surgery for the first time
• Patients who can be communicated verbally
• Patients without any psychiatric disease
• Patients who use smartphones and agree to participate in the study

You may not qualify if:

• Patients under the age of 18
• Patients who have had previous total knee replacement surgery
• Patients who underwent total knee replacement with emergency surgery
• Patients who will undergo bilateral total knee replacement surgery
• Patients with a previous psychiatric diagnosis
• Patients with verbal communication disorders

Sponsors & Collaborators

• Alkay Kara: lead

Study Sites (1)

Giresun University

Giresun, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Kinesiophobia; Sleep Initiation and Maintenance Disorders; Pain

Condition Hierarchy (Ancestors)

Phobic Disorders; Anxiety Disorders; Mental Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Neziha Karabulut, PhD

  Ataturk University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 24, 2021
• First Posted: January 11, 2022
• Study Start: February 1, 2022
• Primary Completion: February 28, 2023
• Study Completion: December 5, 2023
• Last Updated: December 29, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)