Femoral Arterial Sheath RemovalNCT07808632
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
A study testing Stress Ball in people with Femoral Arterial Sheath Removal and Stress Ball, run by Mersin University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Femoral Arterial Sheath Removal, Stress Ball, Pain
- What is being tested?
- Stress Ball
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Nov 2026to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
TUGBA ÇAM YANIK, PHD, RN contact
Turkey (Türkiye)1 site
Turkey, Mersin University Hospital
Yenişehir, Mersin, 33120
Tuğba ÇAM YANIK, 05067703216, tugbacam@mersin.edu.tr
About this study
Official title: 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.
Read the 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.
- Conditions
- Femoral Arterial Sheath Removal, Stress Ball, Pain, Anxiety, Patient Satisfaction, Hemodynamic Parameters
- Being tested
- Stress Ball
- Keywords
- Femoral Arterial Sheath Removal, Stress Ball, Pain, Anxiety, Patient Satisfaction, Hemodynamic Parameters
- Medical subject headings
- Pain, Anxiety Disorders, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stress BallBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Stress Ball Group | Experimental | 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. Receives: Behavioral: Stress Ball |
| Control Group | No intervention | Participants in this group will receive routine care only, without any additional nonpharmacological intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Immediately before femoral arterial sheath removal, immediately after removal, and 5, 15, and 30 minutes after removal.
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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 (%).
Measured: Immediately before femoral arterial sheath removal, immediately after removal, and 5, 15, and 30 minutes after removal.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2026
- Study start10 Nov 2026 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Femoral Arterial Sheath RemovalStudies of the same condition, open and under way.
- More trials run by Mersin UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mersin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tugba CAM YANIK, Mersin University
- Investigators
- Tuğba ÇAM YANIK, Principal investigator, Mersin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07808632
- Sponsor's protocol ID
- Mersin_Unıver
- Status last verified
- Nov 2026
- First submitted
- 2 Sep 2026
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
Akcoban S, Tosun B, Yuksel H. The Effect of Stress Ball Use on Immobilization Comfort, Pain Level, and Vital Signs in Patients After Coronary Angiography. J Cardiovasc Nurs. 2026 Jan-Feb 01;41(1):E25-E32. doi: 10.1097/JCN.0000000000001202. Epub 2025 Apr 9.
PubMed 40198758Yuksel D, Gunes D. The Effect of Stress Ball on Anxiety and Pain Levels in Angiography: A Randomized Controlled Trial. Cardiovasc Ther. 2024 Aug 24;2024:5049092. doi: 10.1155/2024/5049092. eCollection 2024.
PubMed 39742013
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography on Pain, Anxiety, Patient Satisfaction, and Hemodynamic Parameters
- ClinicalTrials.gov ID
- NCT07808632
- Acronym / sponsor ID
- Mersin_Unıver
- Conditions
- Femoral Arterial Sheath Removal, Stress Ball, Pain, Anxiety, Patient Satisfaction, Hemodynamic Parameters
- Keywords
- Femoral Arterial Sheath Removal, Stress Ball, Pain, Anxiety, Patient Satisfaction, Hemodynamic Parameters
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Mersin UniversityUniversity, hospital or other
- Study start
- 10 Nov 2026 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 9 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stress Ball Group | Experimental | Behavioral: Stress BallParticipants 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. |
| Control Group | No intervention | –Participants in this group will receive routine care only, without any additional nonpharmacological intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stress BallParticipants 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. | Behavioural | Stress Ball Group |
Primary outcome
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.
7 secondary outcomes
Anxiety Level
Time frame: 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.
Systolic Blood Pressure
Time frame: 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.
Heart Rate
Time frame: 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.
Peripheral Oxygen Saturation
Time frame: Immediately before femoral arterial sheath removal, immediately after removal, and 5, 15, and 30 minutes after removal.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- Background: PubMed 40198758Akcoban S, Tosun B, Yuksel H. The Effect of Stress Ball Use on Immobilization Comfort, Pain Level, and Vital Signs in Patients After Coronary Angiography. J Cardiovasc Nurs. 2026 Jan-Feb 01;41(1):E25-E32. doi: 10.1097/JCN.0000000000001202. Epub 2025 Apr 9.
- Background: PubMed 39742013Yuksel D, Gunes D. The Effect of Stress Ball on Anxiety and Pain Levels in Angiography: A Randomized Controlled Trial. Cardiovasc Ther. 2024 Aug 24;2024:5049092. doi: 10.1155/2024/5049092. eCollection 2024.
- Individual participant dataSharing planned: 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.
Related trials for Femoral Arterial Sheath Removal
RecruitingObservational study
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Removal of Femoral Arterial Sheath in ICU Patients, Complete Hemostasis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
TUGBA ÇAM YANIK, PHD, RN contact
Tuğba ÇAM YANIK principal investigator
Mersin University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stress Ball in people with Femoral Arterial Sheath Removal and Stress Ball, run by Mersin University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tuğba ÇAM YANIK, PHD (05067703216, tugbacam@mersin.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Intensity (time frame: Immediately before femoral arterial sheath removal, immediately after removal, and 5, 15, and 30 minutes after removal.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07808632, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.