Effect of Game Activity and Stress Ball on Anxiety and Vital Signs
Effectiveness of Game Activity and Stress Ball on Preoperative Anxiety and Vital Signs
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Filiz Assist. Prof. Filiz Salman Saraç
- Phone Number: +90 232 211 3713
- Email: filizsalman@sdu.edu.tr
Study Locations
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Isparta, Turkey, 32200
- Recruiting
- Isparta Şehir Hastanesi
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Contact:
- Assist. Prof. Filiz Salman Saraç
- Email: filizsalman@sdu.edu.tr
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention Group 1
The game designated for the group game activity will be played with the patient, the patient's relative, and the researcher before the surgery.
Data will be collected by another researcher before the game is played, and measurements will be taken again using data collection tools after the group game activity.
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A game determined by the researcher will be played with the patients in the patient room.
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Experimental: Intervention Group 2
Patients will use the stress ball for 15 minutes before surgery.
Data will be collected with data collection tools before and after using the stress ball.
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Patients will use the stress ball for 15 minutes.
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No Intervention: Control Group
No intervention will be performed on patients.
Data will be collected twice before surgery.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
State Anxiety Inventory (STAI-I)
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.
|
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
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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.
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Pain Level
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.
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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.
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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.
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Temperature
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.
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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).
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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.
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Blood pressure
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.
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Patients' blood pressure will be measured in mmHg using a portable bedside monitor.
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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.
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Heart rate
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.
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Patients' pulses will be measured in beats/minute using a portable bedside monitor.
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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.
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Saturation
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.
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Saturation of patients will be measured in % using a portable bedside monitor
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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.
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Respiratory rate
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.
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The respiratory rate of the patients will be measured by monitoring the patient's chest movements in one minute.
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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.
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SuleymanDU_SALMAN-F-002
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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