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临床试验/NCT05187065
NCT05187065已完成不适用

The Effect of Mobile-based Education and Exercise Program Given to Patients With Total Knee Replacement Surgery on Anxiety, Kinesiophobia, and Physical Function

Alkay Kara1 个研究点 分布在 1 个国家目标入组 108 人开始时间: 2022年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
108
试验地点
1
主要终点
Knee injury and osteoarthritis outcome score-physical function short-form

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

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

时间窗: 4 weeks

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.

Visual Analog Scale

时间窗: 4 weeks

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.

Visual Analog Sleep Scale

时间窗: 4 weeks

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.

State-Trait Anxiety Scale

时间窗: 4 weeks

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).

Tampa Scale for Kinesiophobia

时间窗: 4 weeks

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.

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

时间窗: 4 weeks

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

次要结局

未报告次要终点

研究者

发起方
Alkay Kara
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Alkay Kara

Principal Investigator

Giresun University

研究点 (1)

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