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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorSakarya University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

400 Participants
are divided into 2 treatment groups
Group A: Stress Ball GroupExperimental treatment 1 intervention
Group B: Control GroupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Radial Artery Spasm Rate

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

Time frame
Periprocedural
2

Pain Score During Procedure (VAS)

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

Time frame
Immediately after the procedure

Secondary outcomes

1

Radial Artery Occlusion (RAO)

Radial artery occlusion confirmed by color Doppler ultrasonography. RAO is defined as the absence of flow in the radial artery at the puncture site, assessed in both longitudinal and transverse views.

Time frame
7 days after the procedure
2

Radial Artery Cannulation Duration

Total time from radial sheath insertion, measured in minutes.

Time frame
During radial artery cannulation procedure
3

Number of Puncture Attempts

Number of needle punctures required for successful access.

Time frame
During radial artery cannulation procedure

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: