Effect of Game Activity and Stress Ball on Anxiety and Vital Signs
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSuleyman Demirel University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Game activity
BehavioralA game determined by the researcher will be played with the patients in the patient room.
Stres Ball
DevicePatients will use the stress ball for 15 minutes.
Treatment groups
75 Participants
are divided into 3 treatment groupsGroup A: Intervention Group 1Experimental treatment 1 intervention
Group B: Intervention Group 2Experimental treatment 1 intervention
Group C: Control GroupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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
Time frame
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.2
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.
Time frame
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.3
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).
Time frame
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.4
Blood pressure
Patients' blood pressure will be measured in mmHg using a portable bedside monitor.
Time frame
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.Sponsors and contacts
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Source ClinicalTrials.gov