Impact of Preprocedural Stress Ball Use on Radial Artery Outcomes in Elective Coronary Angiography: A Randomized Controlled Trial
Phase: NA
Conditions: Coronary Arterial Disease (CAD), Radial Artery Spasm, Radial Artery Occlusion, Transradial Angiogram, Visual Analog Pain Scale
Sponsor: Sakarya University

Impact of Preprocedural Stress Ball Use on Radial Artery Outcomes 
in Elective Coronary Angiography: A Randomized Controlled Trial 
 
NCT Number: Pending 
 
Date: July 18, 2025 

Impact of Preprocedural Stress Ball Use on Radial Artery Outcomes in Elective Coronary 
Angiography: A Randomized Controlled Trial 
Study Protocol and Statistical Analysis Plan 
1. Background and Rationale 
Radial artery occlusion (RAO) is a common complication following transradial coronary 
angiography. Pre-procedural hand exercises, such as stress ball use, may improve arterial 
compliance and reduce the risk of RAO. This randomized controlled trial (RCT) investigates 
whether scheduled stress ball use in the days prior to elective radial angiography reduces the 
incidence of RAO at 7 days. 
2. Objectives 
Primary Objective: 
To assess the effect of preprocedural stress ball use on the rate of radial artery occlusion at day 7 
post-procedure, confirmed by Doppler ultrasonography. 
Secondary Objectives: 
•
To evaluate the incidence of intra-procedural radial artery spasm 
•
To compare procedure-related pain scores (VAS) 
•
To assess time to successful radial artery cannulation 
•
To record the number of puncture attempts 
3. Study Design 
•
Type: Interventional (Clinical Trial) 
•
Design: Prospective, Randomized, Double-Blind, Parallel Assignment 
•
Number of Arms: 2 
•
Masking: Double-blind (Participant and Interventional Cardiologist) 
•
Primary Purpose: Prevention 
•
Planned Sample Size: 400 participants 
4. Eligibility Criteria 
 Inclusion Criteria: 
-Age between 18 and 85 years 
-Elective radial coronary angiography planned 
-Written informed consent provided 
-Ability to understand and comply with the stress ball exercise protocol (3×5 minutes/day for 3 days 
prior to procedure) 
-Palpable radial pulse on the planned access site 
Exclusion Criteria: 
-Emergent or urgent coronary procedures 
-Known radial artery occlusion or non-palpable radial pulse on the intended access side 
-Prior arteriovenous fistula or vascular surgery in the ipsilateral arm 
-History of Raynaud’s disease, severe peripheral artery disease, or Buerger’s disease 
-Neurological or musculoskeletal disorders affecting hand grip (e.g., stroke, advanced arthritis, 
peripheral neuropathy) 
-Cognitive impairment or psychiatric condition preventing protocol adherence 
-Inability to use hand muscles effectively (e.g., recent hand trauma, paralysis) 
-Unwillingness or inability to perform the stress ball exercises as instructed 
-Pregnancy or breastfeeding 
5. Intervention 
Arm A: Stress Ball Group 

•
Participants will squeeze a soft stress ball for 5 minutes, three times daily, for 3 days before 
the procedure. 
Arm B: Standard Care Group 
•
No preprocedural exercise; standard preparation. 
6. Outcome Measures 
Primary Outcome: 
•
Radial Artery Occlusion at Day 7: Confirmed via Doppler USG 
Secondary Outcomes: 
•
Radial artery spasm rate during procedure (operator reported) 
•
Pain score (VAS) during procedure 
•
Time to successful cannulation (in seconds) 
•
Number of puncture attempts 
7. Randomization and Blinding 
Patients will be randomized 1:1. Allocation will be concealed. Outcome assessors and operating 
interventional cardiologists will be blinded to group assignment. 
8. Statistical Analysis Plan 
•
Descriptive statistics for baseline data 
•
Chi-square test for primary endpoint 
•
Independent t-test or Mann-Whitney U for continuous secondary outcomes 
•
Statistical significance set at p < 0.05 
•
Analysis will be performed using SPSS version XX 
9. Ethics and Registration 
The study protocol has been reviewed and approved by the Sakarya University Faculty of Medicine 
Scientific Research Ethics Committee. 
10. Dissemination Plan 
The results of the study will be submitted for publication in peer-reviewed journals and presented at 
national/international cardiology conferences.