Clinical trial NCT06523413: Effect of Game Activity and Stress Ball on Anxiety and Vital Signs
Official title: Effectiveness of Game Activity and Stress Ball on Preoperative Anxiety and Vital Signs
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Anxiety
Arthroplasty Complications
Keywords: anxiety
vital signs
artroplasty
Lead sponsor: Suleyman Demirel University
Sponsor class: OTHER
First posted: 2024-07-26
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: State Anxiety Inventory (STAI-I)
timeFrame: 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.
measure: Pain Level
timeFrame: 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.
measure: Temperature
timeFrame: 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.
measure: Blood pressure
timeFrame: 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.
measure: Heart rate
timeFrame: 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.
measure: Saturation
timeFrame: 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.
measure: Respiratory rate
timeFrame: 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.
Secondary outcomes:
Other outcomes:
Locations:
city: Isparta
country: Turkey
facility: Isparta Şehir Hastanesi
Study officials:
References: