An interventional study of Stress Ball in Femoral Arterial Sheath Removal, Stress Ball and Pain, sponsored by Mersin University. Not yet recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-09.
Sponsored by Mersin University · Not applicable, Interventional, and Supportive care
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.
Coronary angiography is a commonly used invasive procedure for the diagnosis and treatment of coronary artery disease. Following coronary angiography performed via the femoral artery, removal of the femoral arterial sheath may cause pain and anxiety and may lead to changes in hemodynamic parameters. Therefore, simple, safe, and nonpharmacological nursing interventions that can improve patient comfort during femoral arterial sheath removal are important.
This prospective, two-arm, 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. The study will include 34 patients who meet the eligibility criteria. Participants will be randomly assigned in a 1:1 ratio to either the stress ball intervention group (n=17) or the control group (n=17) using block randomization.
Participants assigned to the intervention group will receive a stress ball immediately before femoral arterial sheath removal. A round, medium-firm silicone stress ball approximately 6 cm in diameter will be used. Participants will be instructed to hold the stress ball in 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. Participants in the control group will receive routine clinical care without any additional nonpharmacological intervention.
Pain intensity will be assessed using the Visual Analog Scale (VAS), anxiety using the Visual Analog Scale for Anxiety (VAS-A), and patient satisfaction using the Visual Analog Scale for Patient Satisfaction (VAS-PS). Hemodynamic parameters will include systolic blood pressure, diastolic blood pressure, heart rate, respiratory rate, and peripheral oxygen saturation (SpO2).
Assessments will be performed at five predefined time points: immediately before femoral arterial sheath removal (T0), immediately after sheath removal (T1), and at 5 minutes (T2), 15 minutes (T3), and 30 minutes (T4) after the procedure. Routine medical treatment and nursing care will be continued for participants in both groups throughout the study.
The primary outcome of the study is pain intensity associated with femoral arterial sheath removal. Secondary outcomes include anxiety, patient satisfaction, systolic and diastolic blood pressure, heart rate, respiratory rate, and peripheral oxygen saturation. The findings are expected to provide evidence regarding the effectiveness of stress ball use as a simple, low-cost, noninvasive nursing intervention during femoral arterial sheath removal after coronary angiography.
Exclusion Criteria:
Participants in this group will use a stress ball in addition to routine care. The stress ball 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.
Behavioral: Stress Ball
Participants in this group will receive routine care only, without any additional nonpharmacological intervention.
Participants 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.
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.
Time frame: Immediately before femoral arterial sheath removal, immediately after removal, and 5, 15, and 30 minutes after removal.
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.
Time frame: Immediately before femoral arterial sheath removal, immediately after removal, and 5, 15, and 30 minutes after removal.
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.
Time frame: Immediately before femoral arterial sheath removal and 30 minutes after removal.
Systolic Blood Pressure
Systolic blood pressure will be measured using a bedside patient monitor and recorded in millimeters of mercury (mmHg).
Time frame: Immediately before femoral arterial sheath removal, immediately after removal, and 5, 15, and 30 minutes after removal.
Diastolic Blood Pressure
Diastolic blood pressure will be measured using a bedside patient monitor and recorded in millimeters of mercury (mmHg).
Time frame: Immediately before femoral arterial sheath removal, immediately after removal, and 5, 15, and 30 minutes after removal.
Heart Rate
Heart rate will be measured using a bedside patient monitor and recorded as beats per minute (beats/min).
Time frame: Immediately before femoral arterial sheath removal, immediately after removal, and 5, 15, and 30 minutes after removal.
Respiratory Rate
Respiratory rate will be assessed by counting the participant's respirations for one minute and recorded as breaths per minute.
Time frame: Immediately before femoral arterial sheath removal, immediately after removal, and 5, 15, and 30 minutes after removal.
Peripheral Oxygen Saturation
Peripheral oxygen saturation (SpO2) will be measured using a pulse oximeter and recorded as a percentage (%).
Time frame: Immediately before femoral arterial sheath removal, immediately after removal, and 5, 15, and 30 minutes after removal.
Plan to share: No — Individual participant data (IPD) will not be shared due to participant confidentiality and data protection considerations. Aggregate study findings will be reported in scientific publications.
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Mersin University