Stress Ball
Conditions
Keywords
anxiety, procedure-related fear, physiological parameters, comfort
Brief summary
The aim of this study is to investigate the effect of stress ball application during coronary angiography on anxiety, procedure-related fear, physiological parameters, and comfort. The study is designed as a prospective, randomized controlled clinical trial. The study population will consist of patients scheduled to undergo coronary angiography at Tarsus State Hospital. The sample size was calculated based on the post-test anxiety score effect size (Cohen's d = 0.43) reported in the study by Yüksel and Güneş (2024), which examined the effect of stress ball application on anxiety and pain levels during angiography procedures. Using a significance level of α = 0.05 and a statistical power of 90% (1-β = 0.90), the required sample size was calculated as 59 participants. To account for potential attrition, the sample size was increased by 10%, resulting in a final sample of 64 participants (intervention group: n = 32; control group: n = 32). Data will be collected using the Descriptive Characteristics Form, State Anxiety Inventory, Procedure-Related Fear Scale, Physiological Parameters Monitoring Form, and Comfort Assessment Form. Upon admission to the coronary angiography unit and before the procedure, all participants will complete the Descriptive Characteristics Form, State Anxiety Inventory, Procedure-Related Fear Scale, and Physiological Parameters Monitoring Form. These assessments will be administered by researcher NÇ. In addition to routine care, patients in the intervention group will be instructed to squeeze a medium-resistance stress ball, hold the squeeze while counting to five, then release it, and repeat this cycle throughout the angiography procedure. Researcher GB will be responsible for implementing the intervention. Patients in the control group will receive only the unit's standard care. Routine care includes pre-procedural patient education, assessment of vital signs, verification of intravenous line patency, preparation of the vascular access site, and standard patient monitoring throughout the procedure. Care will be provided according to the standard care protocol routinely implemented in the hospital's coronary angiography unit. Immediately after the procedure, the State Anxiety Inventory, Procedure-Related Fear Scale, Physiological Parameters Monitoring Form, and Comfort Assessment Form will be administered by researcher NÇ.
Detailed description
The aim of this study is to investigate the effect of stress ball application during coronary angiography on anxiety, procedure-related fear, physiological parameters, and comfort. The study is designed as a prospective, randomized controlled clinical trial. The study population will consist of patients scheduled to undergo coronary angiography at Tarsus State Hospital. The sample size was calculated based on the post-test anxiety score effect size (Cohen's d = 0.43) reported in the study by Yüksel and Güneş (2024), which examined the effect of stress ball application on anxiety and pain levels during angiography procedures. Using a significance level of α = 0.05 and a statistical power of 90% (1-β = 0.90), the required sample size was calculated as 59 participants. To account for potential attrition, the sample size was increased by 10%, resulting in a final sample of 64 participants (intervention group: n = 32; control group: n = 32). Data will be collected using the Descriptive Characteristics Form, State Anxiety Inventory, Procedure-Related Fear Scale, Physiological Parameters Monitoring Form, and Comfort Assessment Form. Upon admission to the coronary angiography unit and before the procedure, all participants will complete the Descriptive Characteristics Form, State Anxiety Inventory, Procedure-Related Fear Scale, and Physiological Parameters Monitoring Form. These assessments will be administered by researcher NÇ. In addition to routine care, patients in the intervention group will be instructed to squeeze a medium-resistance stress ball, hold the squeeze while counting to five, then release it, and repeat this cycle throughout the angiography procedure. Researcher GB will be responsible for implementing the intervention. Patients in the control group will receive only the unit's standard care. Routine care includes pre-procedural patient education, assessment of vital signs, verification of intravenous line patency, preparation of the vascular access site, and standard patient monitoring throughout the procedure. Care will be provided according to the standard care protocol routinely implemented in the hospital's coronary angiography unit. Immediately after the procedure, the State Anxiety Inventory, Procedure-Related Fear Scale, Physiological Parameters Monitoring Form, and Comfort Assessment Form will be administered by researcher NÇ. To ensure researcher safety during data collection, all procedures will be conducted in accordance with clinical workplace regulations. Researchers will comply with hospital infection prevention and control measures and will use appropriate personal protective equipment whenever necessary. As data collection will take place in the coronary angiography unit, researchers will also adhere to radiation safety regulations by minimizing their presence within the fluoroscopy field during the procedure and using lead aprons and other radiation-protective equipment whenever required. Furthermore, all data collection activities will be performed in accordance with the institution's occupational health and safety procedures.
Interventions
OTHERStress ball
participants in the intervention group will be instructed to squeeze a medium-resistance stress ball, hold the squeeze while counting to five, then release it, and repeat this cycle throughout the procedure. Researcher GB will be responsible for administering the intervention.
Sponsors
Tarsus University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
To minimize selection bias and ensure balanced group allocation, patients meeting the inclusion criteria will be assigned to either the stress ball intervention group or the control group according to computer-generated permuted block randomization sequences (e.g., ABBA, BABA) prepared by an independent biostatistician who is not involved in the study. After the allocation sequence has been generated, the correspondence between the allocation codes (A and B) and the study groups will be determined by a lottery. An external expert (academic nurse) (GCU), who will not otherwise participate in the study, will prepare sequentially numbered opaque sealed envelopes (numbered 1 to 64). Each envelope will contain the group assignment according to the predetermined randomization list. Patients presenting to the Coronary Angiography Unit will be assessed for eligibility. Those who meet the inclusion criteria, agree to participate, and provide written informed consent will be enrolled in the st
Intervention model description
The study is designed as a prospective, randomized controlled clinical trial.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Aged 18 years or older, as verified by medical records and official identification. * Scheduled to undergo elective coronary angiography, as confirmed by the patient's medical records. * Conscious, oriented, and cooperative, as assessed by the researcher during the pre-procedural interview. * Able and willing to provide written informed consent after receiving information about the study. * Able to speak Turkish and understand and respond to the questions asked during the study. * No visual, hearing, or speech impairment that would interfere with communication. * No motor or sensory impairment of the hand or arm that would prevent the use of a stress ball, as assessed through patient self-report and clinical observation. * No diagnosed anxiety disorder and no self-reported history of receiving psychiatric treatment for anxiety.
Exclusion criteria
* Decline to participate or request to withdraw from the study at any stage. * Undergo emergency coronary angiography. * Have cognitive, communication, or physical impairments that prevent completion of the data collection instruments or participation in the study procedures. * Develop clinical complications during or after the procedure that preclude implementation of the study protocol.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Anxiety | 10 months | The State Anxiety Scale : In this study, the DAQ, which is structured to measure momentary feelings, was used. Its Turkish validity and reliability was conducted by Öner and Le Compte in 1983. The DAQ consists of 20 questions on a four-point Likert scale. The statements in the DAQ are evaluated as not at all (1), a little (2), a lot (3) and completely (4). In this section, the statements are divided into direct and reversed statements. Inverted statements: 1st, 2nd, 5th, 5th, 8th, 8th, 10th, 11th, 15th, 16th, 19th, 20th items. The total score of the reversed statements is subtracted from the total score of the direct statements and the number 50, which is the invariant value of the DAQ, is added to the value obtained and the DAQ score is calculated. The scale score ranges between 20-80 and an increase in the score indicates an increase in the level of anxiety. |
| Procedure-related Fear | 10 months | Patients' fear will be assessed using a visual analog scale (VAS) ranging from 0 to 10; 0 represents "No fear at all," and 10 represents "Maximum fear." The minimum possible score is 0, and the maximum score is 10. Higher total scores indicate a higher level of fear experienced by the patient during or prior to the procedure. |
| Physiological Parameters | 10 months | It is a form used to record patients' Physiological Parameters before and after the procedure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Comfort | 10 months | Patients will assess their comfort using a 10-cm Visual Analog Scale (VAS) ranging from 0 to 10 (Wewers \& Lowe, 1990). A score of 0 indicates "Not comfortable at all," whereas a score of 10 indicates "Extremely comfortable." The total score ranges from 0 to 10, with higher scores indicating greater perceived comfort. |
Countries
Turkey (Türkiye)
Contacts
CONTACTGamze Bozkul
CONTACTGAMZE BOZKUL
STUDY_DIRECTORGamze Bozkul
Tarsus University
Outcome results
None listed