Effect of Game Activity and Stress Ball on Anxiety and Vital Signs
NCT Number: NCT06523413
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Anxiety|Arthroplasty Complications
Interventions: BEHAVIORAL: Game activity|DEVICE: Stres Ball
Sponsor: Suleyman Demirel University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 75
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-07
Completion Date: 2024-12

Summary:
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.

Primary Outcome Measures: State Anxiety Inventory (STAI-I), 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, 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.|Pain Level, 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., 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.|Temperature, 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)., 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.|Blood pressure, Patients' blood pressure will be measured in mmHg using a portable bedside monitor., 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.|Heart rate, Patients' pulses will be measured in beats/minute using a portable bedside monitor., 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, Saturation of patients will be measured in % using a portable bedside monitor, 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.|Respiratory rate, The respiratory rate of the patients will be measured by monitoring the patient's chest movements in one minute., 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.