Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMersin University

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Stress Ball

    Behavioral

    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.

Treatment groups

34 Participants
are divided into 2 treatment groups
Group A: Stress Ball GroupExperimental treatment 1 intervention
Group B: Control GroupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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.

Secondary outcomes

1

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.
2

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.
3

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.
4

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.

Other outcomes

Sponsors and contacts

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