About this trial
This randomized controlled trial aims to evaluate the effects of stress ball use during femoral arterial sheath removal after coronary angiography on pain, anxiety, patient satisfaction, and hemodynamic parameters. A total of 34 patients will be randomly assigned in a 1:1 ratio to either the intervention group or the control group. Participants in the intervention group will use a stress ball during femoral arterial sheath removal in addition to routine care, while participants in the control group will receive routine care only. Pain, anxiety, patient satisfaction, and hemodynamic parameters will be assessed before and at specified time points after femoral arterial sheath removal.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients who underwent coronary angiography via the femoral artery and received stent implantation or balloon angioplasty
Aged 18 years or older
Willing to participate in the study and providing written informed consent
Conscious, oriented, and cooperative
Disqualifiers
Coronary angiography performed via the radial artery
Development of a complication during coronary angiography, such as arrhythmia
Administration of sedation during coronary angiography
Pregnancy
Trial design
Parallel
Treatments tested in this trial
Stress Ball
BehavioralParticipants will be given a round, medium-firm silicone stress ball approximately 6 cm in diameter. They will be instructed to hold the stress ball in the palm of their hand and rhythmically squeeze and release it after counting to three. The intervention will begin approximately one minute before femoral arterial sheath removal and will continue during and after sheath removal for a total of 10 minutes. Routine clinical care will continue throughout the intervention.
Treatment groups
Trial outcomes
Primary outcomes
Pain Intensity
Pain intensity will be assessed using a 10-cm Visual Analog Scale (VAS), ranging from 0 (no pain) to 10 (worst possible pain). Higher scores indicate greater pain intensity.
Secondary outcomes
Anxiety Level
Anxiety will be assessed using the Visual Analog Scale for Anxiety (VAS-A), a 10-cm scale ranging from 0 (no anxiety) to 10 (highest possible anxiety). Higher scores indicate greater anxiety.
Patient Satisfaction
Patient satisfaction will be assessed using the Visual Analog Scale for Patient Satisfaction (VAS-PS), a 10-cm scale ranging from 0 (not satisfied at all) to 10 (completely satisfied). Higher scores indicate greater patient satisfaction.
Systolic Blood Pressure
Systolic blood pressure will be measured using a bedside patient monitor and recorded in millimeters of mercury (mmHg).
Diastolic Blood Pressure
Diastolic blood pressure will be measured using a bedside patient monitor and recorded in millimeters of mercury (mmHg).
Sponsors and contacts
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