Actively Recruiting
Effectiveness of Game Activity and Stress Ball on Preoperative Anxiety and Vital Signs in Total Knee Arthroplasty
Led by Suleyman Demirel University · Updated on 2024-12-17
75
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the effects of game activity and stress ball use on preoperative anxiety and vital signs in patients undergoing total knee arthroplasty. The study focuses on adults over 18 who are cognitively competent as tested by the Mini-Cog. Anxiety before surgery can negatively impact surgical outcomes and patient satisfaction, so managing it is important in this population. The trial compares these two distraction methods against a control group receiving no intervention. Participants are randomly assigned to one of three groups: one group plays a designated game with a researcher and a relative before surgery, another group uses a stress ball for 15 minutes prior to surgery, and the control group receives no intervention. Data collection occurs before and after the interventions or at matched times for the control group. The interventions are simple, low-cost, and designed to be easy for patients to use. During the study, researchers collect data using the State Anxiety Inventory and record vital signs including temperature, blood pressure, heart rate, oxygen saturation, respiratory rate, and pain levels. Measurements are taken at the first encounter and again 15 minutes after the intervention, or one hour after the first measurement for the control group. The study monitors these outcomes to assess how the interventions impact anxiety and physiological responses before surgery.
CONDITIONS
Brief Title
Effect of Game Activity and Stress Ball on Anxiety and Vital Signs
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Be over 18 years old
- Scheduled for total knee arthroplasty surgery
- Have passed the Mini-Cog cognitive test
- Able to understand, read, and write Turkish
- Have no hearing or speech problems
- Have a person accompanying you during surgery
You will not qualify if you...
- Do not want to participate in the research
- Have an unstable general condition
- Experience sudden changes in vital signs
- Have a psychological disorder and use antidepressant medication
- Have any psychiatric or cognitive/mental disease such as dementia
- Use psychiatric medication for any reason
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single session before surgery
Participants undergo a game activity or use a stress ball for 15 minutes before surgery to reduce preoperative anxiety. Those in the control group receive no intervention.
1 visit (in-person)
Duration - Approximately 1 hour including measurements before and after intervention
Participants have their anxiety levels and vital signs measured before and after the intervention or equivalent time for the control group.
1 visit (in-person)
Trial Site Locations
Total: 1 location
1
Isparta Şehir Hastanesi
Isparta, Turkey (Türkiye), 32200
Actively Recruiting
Research Team
F
Filiz Assist. Prof. Filiz Salman Saraç
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
3
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