AnxietyNCT06523413
Effect of Game Activity and Stress Ball on Anxiety and Vital Signs
A study testing Game activity and Stres Ball in people with Anxiety and Arthroplasty Complications, run by Suleyman Demirel University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anxiety, Arthroplasty Complications
- What is being tested?
- Game activity and Stres Ball
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2024to 30 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Game Activity and Stress Ball on Preoperative Anxiety and Vital Signs
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.
Read the 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.
- Conditions
- Anxiety, Arthroplasty Complications
- Being tested
- Game activity, Stres Ball
- Keywords
- anxiety, vital signs, artroplasty
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Game activityBehavioural
A game determined by the researcher will be played with the patients in the patient room.
Stres BallDevice
Patients will use the stress ball for 15 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group 1 | Experimental | 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. Receives: Behavioral: Game activity |
| Intervention Group 2 | Experimental | 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. Receives: Device: Stres Ball |
| Control Group | No intervention | No intervention will be performed on patients. Data will be collected twice before surgery. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2024
- Study start1 Aug 2024
- Primary completion30 Jul 2025
- Study completion30 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Suleyman Demirel University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Filiz Salman Saraç, Suleyman Demirel University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06523413
- Sponsor's protocol ID
- SuleymanDU_SALMAN-F-002
- Status last verified
- Nov 2026
- First submitted
- 2 Jul 2024
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Game Activity and Stress Ball on Preoperative Anxiety and Vital Signs
- ClinicalTrials.gov ID
- NCT06523413
- Acronym / sponsor ID
- SuleymanDU_SALMAN-F-002
- Conditions
- Anxiety, Arthroplasty Complications
- Keywords
- anxiety, vital signs, artroplasty
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Suleyman Demirel UniversityUniversity, hospital or other
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 30 Jul 2025 (actual)
- Study completion
- 30 Jul 2025 (actual)
- First posted
- 26 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intervention Group 1 | Experimental | Behavioral: Game activityThe 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. |
| Intervention Group 2 | Experimental | Device: Stres BallPatients 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. |
| Control Group | No intervention | –No intervention will be performed on patients. Data will be collected twice before surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Game activityA game determined by the researcher will be played with the patients in the patient room. | Behavioural | Intervention Group 1 |
| Stres BallPatients will use the stress ball for 15 minutes. | Device | Intervention Group 2 |
Primary outcome
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
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.
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.
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.
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).
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.
Patients' blood pressure will be measured in mmHg using a portable bedside monitor.
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.
Patients' pulses will be measured in beats/minute using a portable bedside monitor.
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.
Saturation of patients will be measured in % using a portable bedside monitor
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.
The respiratory rate of the patients will be measured by monitoring the patient's chest movements in one minute.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Game activity and Stres Ball in people with Anxiety and Arthroplasty Complications, run by Suleyman Demirel University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.