Impact of Preprocedural Stress Ball Use on Radial Artery Outcomes in Elective Coronary Angiography

NCT07087522 | Not Yet Recruiting

• 1 other identifier: SEAH-2025-SPARROW-001
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized, double-blind, controlled trial aims to evaluate the effect of preprocedural hand exercise using a stress ball on the incidence of radial artery spasm and other vascular complications in patients undergoing elective coronary angiography via the transradial approach. A total of 400 adult patients scheduled for elective diagnostic or interventional coronary procedures will be randomly assigned to either an intervention group (preprocedural stress ball exercise) or a control group (standard care). The intervention group will perform hand exercises with a soft stress ball for 5 minutes, three times daily, for three consecutive days prior to the procedure. The primary outcomes are the incidence of radial artery spasm during the procedure and the overall rate of radial artery complications. Secondary outcomes include patient-reported pain score (visual analog scale) during the procedure and the incidence of radial artery occlusion at 7 days, assessed by Doppler ultrasonography. This study aims to determine whether this simple, low-cost strategy can reduce radial artery-related complications and improve patient comfort during transradial coronary procedures.

Conditions

Coronary Arterial Disease (CAD); Radial Artery Spasm; Radial Artery Occlusion; Transradial Angiogram; Visual Analog Pain Scale

Keywords

Radial Artery; Radial Artery Spasm; Radial Artery Occlusion; Coronary Anjiography; Transradial Approach; Hand Exercise; Stress Ball; Vascular Complications

Outcome Measures

Primary Outcomes (2)

• Radial Artery Spasm Rate

  Incidence of periprocedural radial artery spasm as reported by the operator, characterized by catheter resistance, patient discomfort, or vasodilator need.

  Periprocedural

• Pain Score During Procedure (VAS)

  Visual Analog Scale (VAS) score reported by the patient (0 = no pain, 10 = worst pain imaginable).

  Immediately after the procedure

Secondary Outcomes (3)

• Radial Artery Occlusion (RAO)

  7 days after the procedure

• Radial Artery Cannulation Duration

  During radial artery cannulation procedure

• Number of Puncture Attempts

  During radial artery cannulation procedure

Study Arms (2)

Stress Ball Group

EXPERIMENTAL

Participants will perform hand exercises using a stress ball for 5 minutes, 3 times per day, for 3 consecutive days prior to radial angiography.

Behavioral: Stress Ball Use

Control Group

NO INTERVENTION

No hand exercise or stress ball use will be applied before radial angiography.

Interventions

Stress Ball Use BEHAVIORAL

Participants will perform hand exercises using a rubber stress ball for 5 minutes, 3 times daily, for 3 days prior to radial angiography.

Stress Ball Group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sakarya University: lead

Study Sites (1)

Sakarya University Training and Research Hospital

Sakarya, Adapazarı, 54100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Arterial Occlusive Diseases

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

EMRE EYNEL, MD

CONTACT

+905436342456; emreeynel@icloud.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Both the interventional cardiologist performing the radial procedure and the outcome assessor conducting the Doppler ultrasonography will be blinded to the participant's group allocation. This double-blind design aims to minimize procedural and assessment bias.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Emre Eynel, Specialist in Cardiology

Model Details: Participants will be randomly assigned to either the intervention group (stress ball use) or the control group (standard care) in a parallel design, with no crossover between groups.

Study Record Dates

• First Submitted: June 16, 2025
• First Posted: July 28, 2025
• Study Start: September 1, 2025
• Primary Completion: February 27, 2026
• Study Completion: March 31, 2026
• Last Updated: July 28, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: 6 months after publication of the primary results.
• Access Criteria: Qualified researchers with a methodologically sound proposal and appropriate institutional ethics approval may request access to the data. A formal data-sharing agreement must be signed. Requests will be reviewed and approved by the principal investigator (Dr. Emre Eynel).

Locations

TU (1)