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

September 2, 2026 updated by: Tugba CAM YANIK, Mersin University

The Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography on Pain, Anxiety, Patient Satisfaction, and Hemodynamic Parameters

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
34

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Stress Ball Group
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 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.
No Intervention: Control Group
Participants in this group will receive routine care only, without any additional nonpharmacological intervention.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Pain Intensity
Time Frame: 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.
Immediately before femoral arterial sheath removal, immediately after removal, and 5, 15, and 30 minutes after removal.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Anxiety Level
Time Frame: 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.
Immediately before femoral arterial sheath removal, immediately after removal, and 5, 15, and 30 minutes after removal.
Patient Satisfaction
Time Frame: 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.
Immediately before femoral arterial sheath removal and 30 minutes after removal.
Systolic Blood Pressure
Time Frame: 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).
Immediately before femoral arterial sheath removal, immediately after removal, and 5, 15, and 30 minutes after removal.
Diastolic Blood Pressure
Time Frame: 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).
Immediately before femoral arterial sheath removal, immediately after removal, and 5, 15, and 30 minutes after removal.
Heart Rate
Time Frame: 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).
Immediately before femoral arterial sheath removal, immediately after removal, and 5, 15, and 30 minutes after removal.
Respiratory Rate
Time Frame: 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.
Immediately before femoral arterial sheath removal, immediately after removal, and 5, 15, and 30 minutes after removal.
Peripheral Oxygen Saturation
Time Frame: 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 (%).
Immediately before femoral arterial sheath removal, immediately after removal, and 5, 15, and 30 minutes after removal.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Mersin University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Tuğba ÇAM YANIK, Mersin University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 10, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 2, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 2, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 9, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 9, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 2, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Mersin_Unıver

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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