Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
The Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography on Pain, Anxiety, Patient Satisfaction, and Hemodynamic Parameters
1 other identifier
interventional
34
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2026
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 2, 2026
CompletedFirst Posted
Study publicly available on registry
September 9, 2026
CompletedStudy Start
First participant enrolled
September 10, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2027
September 9, 2026
September 1, 2026
10 months
September 2, 2026
September 2, 2026
Conditions
Keywords
Outcome Measures
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.
Immediately before femoral arterial sheath removal, immediately after removal, and 5, 15, and 30 minutes after removal.
Secondary Outcomes (7)
Anxiety Level
Immediately before femoral arterial sheath removal, immediately after removal, and 5, 15, and 30 minutes after removal.
Patient Satisfaction
Immediately before femoral arterial sheath removal and 30 minutes after removal.
Systolic Blood Pressure
Immediately before femoral arterial sheath removal, immediately after removal, and 5, 15, and 30 minutes after removal.
Diastolic Blood Pressure
Immediately before femoral arterial sheath removal, immediately after removal, and 5, 15, and 30 minutes after removal.
Heart Rate
Immediately before femoral arterial sheath removal, immediately after removal, and 5, 15, and 30 minutes after removal.
- +2 more secondary outcomes
Study Arms (2)
Stress Ball Group
EXPERIMENTALParticipants 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 INTERVENTIONParticipants in this group will receive routine care only, without any additional nonpharmacological intervention.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Turkey, Mersin University Hospital
Yenişehir, Mersin, 33120, Turkey (Türkiye)
Related Publications (2)
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.
PMID: 40198758BACKGROUNDYuksel 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.
PMID: 39742013BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Tuğba ÇAM YANIK
Mersin University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Masking Details
- 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.
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor of Surgical Diseases Nursing
Study Record Dates
First Submitted
September 2, 2026
First Posted
September 9, 2026
Study Start
September 10, 2026
Primary Completion (Estimated)
June 30, 2027
Study Completion (Estimated)
June 30, 2027
Last Updated
September 9, 2026
Record last verified: 2026-09
Data Sharing
- IPD Sharing
- Will not share
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.