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临床试验/NCT06523413
NCT06523413招募中不适用

Effectiveness of Game Activity and Stress Ball on Preoperative Anxiety and Vital Signs

Suleyman Demirel University2 个研究点 分布在 2 个国家目标入组 75 人开始时间: 2024年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
75
试验地点
2
主要终点
Temperature

研究概览

简要总结

This randomized controlled trial aims to determine the effect of game activity and stress ball use on preoperative anxiety and vital signs in patients undergoing total knee arthroplasty. The primary purpose of the study is to evaluate the effect of these methods (game activity, stress ball use) on patients' anxiety and vital signs. The research involves three groups: one group will engage in a game activity, another group will use a stress ball, and the control group will receive no intervention. Patients over 18 years of age who pass the Mini-Cog test, demonstrate cognitive competence and meet other sampling criteria will be included in the study. Data will be collected using the State Anxiety Scale, a vital signs and pain level form, and a descriptive characteristics form.

详细描述

Preoperative anxiety causes various physiological and psychological reactions. In addition, it is known that preoperative anxiety negatively affects the patient's satisfaction with the surgery, the surgical success rate, and the development of postoperative complications. Total knee arthroplasty (TKA) is a surgical procedure frequently performed today to relieve pain and restore knee joint function. Approximately 30% of patients undergoing TKA experience psychological distress before surgery. Anxiety is a problem that needs to be managed in TKA patients because it negatively affects them in the postoperative period.

Interventions such as music, funny videos, massage, meditation, hypnosis, VR glasses, and motivational interviewing have been used to reduce preoperative anxiety in adults. These methods can be applied by nurses, are low cost, and have few side effects. Gaming activities are also one of the methods used to distract patients and reduce their anxiety levels in the preoperative period. The literature shows that game-based approaches in the management of preoperative anxiety are frequently used with pediatric patients. A stress ball is a method used to draw a person's attention in a different direction by squeezing and loosening the ball held in the palm. Although the use of stress balls has not been widely studied in preoperative anxiety management, research shows that stress balls may be useful in anxiety management. Game activity and stress ball use are methods that are easy to implement and will not burden patients in terms of cost.

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
None

入排标准

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

入选标准

  • Being over 18 years old Undergoing total knee arthroplasty Having passed the Mini-Cog test Ability to understand, read, and write Turkish No hearing or speech problems Having a person accompanying the patient

排除标准

  • Not wanting to participate in the research Unstable general condition Sudden change in vital signs Having a psychological disorder and using antidepressant medication Having any psychiatric or cognitive/mental disease (e.g., dementia) Use of psychiatric medication for any reason

结局指标

主要结局

Temperature

时间窗: The first measurement will be collected at the first encounter with the patient, the last measurements will be collected 15 minutes after the intervention in patients who underwent intervention and 1 hour after the first measurement in the control group.

The temperature of the patients will be measured on the patient's forehead using a digital thermometer. Fever degree will be presented in centigrade (°C).

Respiratory rate

时间窗: The first measurement will be collected at the first encounter with the patient, the last measurements will be collected 15 minutes after the intervention in patients who underwent intervention and 1 hour after the first measurement in the control group.

The respiratory rate of the patients will be measured by monitoring the patient's chest movements in one minute.

Blood pressure

时间窗: The first measurement will be collected at the first encounter with the patient, the last measurements will be collected 15 minutes after the intervention in patients who underwent intervention and 1 hour after the first measurement in the control group.

Patients' blood pressure will be measured in mmHg using a portable bedside monitor.

Heart rate

时间窗: The first measurement will be collected at the first encounter with the patient, the last measurements will be collected 15 minutes after the intervention in patients who underwent intervention and 1 hour after the first measurement in the control group.

Patients' pulses will be measured in beats/minute using a portable bedside monitor.

State Anxiety Inventory (STAI-I)

时间窗: The first measurement will be collected at the first encounter with the patient, the last measurements will be collected 15 minutes after the intervention in patients who underwent intervention and 1 hour after the first measurement in the control group.

State-Trait Anxiety Inventory (STAI), developed by Spielberger (1970), is a self-assessment questionnaire consisting of short statements created to determine the level of anxiety. The scale consists of 20 items. Answers range from 1-4. The total score obtained from the scale is between 20-80. A high score indicates a high level of anxiety

Pain Level

时间窗: The first measurement will be collected at the first encounter with the patient, the last measurements will be collected 15 minutes after the intervention in patients who underwent intervention and 1 hour after the first measurement in the control group.

The intensity of the pain will be quantified using the Visual Analogue Scale (VAS). The scale is evaluated by assigning a score between 0 and 10. On the scale, the absence of pain is indicated by a rating of 0 points, while the most severe pain imaginable is indicated by a rating of 10 points.

Saturation

时间窗: The first measurement will be collected at the first encounter with the patient, the last measurements will be collected 15 minutes after the intervention in patients who underwent intervention and 1 hour after the first measurement in the control group.

Saturation of patients will be measured in % using a portable bedside monitor

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Filiz Salman Saraç

Research Assistant Dr.

Suleyman Demirel University

研究点 (2)

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