Anxiety, Femoral Arterial Sheath Removal, Hemodynamic Parameters, Nonpharmacological Intervention, Pain, Patient Satisfaction, Stress Ball
Conditions
Keywords
Femoral Arterial Sheath Removal, Stress Ball, Pain, Anxiety, Patient Satisfaction, Hemodynamic Parameters
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALStress Ball
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.
Sponsors
Mersin University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Masking description
Due to the nature of the intervention, participants and the researcher administering the intervention cannot be blinded. Data will be coded as Group A and Group B, and the statistical analysis will be performed by an independent statistician who is blinded to group allocation.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 * Able to read and understand Turkish * No hearing or visual impairment that would interfere with participation * Clinically and hemodynamically stable * No diagnosed psychiatric disorder
Exclusion criteria
* Coronary angiography performed via the radial artery * Development of a complication during coronary angiography, such as arrhythmia * Administration of sedation during coronary angiography * Pregnancy * Prisoners or other vulnerable individuals
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Intensity | Immediately before femoral arterial sheath removal, immediately after removal, and 5, 15, and 30 minutes after removal. | 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
| Measure | Time frame | Description |
|---|---|---|
| Peripheral Oxygen Saturation | Immediately before femoral arterial sheath removal, immediately after removal, and 5, 15, and 30 minutes after removal. | Peripheral oxygen saturation (SpO2) will be measured using a pulse oximeter and recorded as a percentage (%). |
| Heart Rate | Immediately before femoral arterial sheath removal, immediately after removal, and 5, 15, and 30 minutes after removal. | Heart rate will be measured using a bedside patient monitor and recorded as beats per minute (beats/min). |
| Diastolic Blood Pressure | Immediately before femoral arterial sheath removal, immediately after removal, and 5, 15, and 30 minutes after removal. | Diastolic blood pressure will be measured using a bedside patient monitor and recorded in millimeters of mercury (mmHg). |
| Anxiety Level | Immediately before femoral arterial sheath removal, immediately after removal, and 5, 15, and 30 minutes after removal. | 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 | Immediately before femoral arterial sheath removal and 30 minutes after removal. | 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. |
| Respiratory Rate | Immediately before femoral arterial sheath removal, immediately after removal, and 5, 15, and 30 minutes after removal. | Respiratory rate will be assessed by counting the participant's respirations for one minute and recorded as breaths per minute. |
| Systolic Blood Pressure | Immediately before femoral arterial sheath removal, immediately after removal, and 5, 15, and 30 minutes after removal. | Systolic blood pressure will be measured using a bedside patient monitor and recorded in millimeters of mercury (mmHg). |
Countries
Turkey (Türkiye)
Contacts
CONTACTTuğba ÇAM YANIK, PHD
CONTACTTUGBA ÇAM YANIK, PHD, RN
PRINCIPAL_INVESTIGATORTuğba ÇAM YANIK
Mersin University
Outcome results
None listed