Effects of Stress Ball Use During Femoral Catheter Removal After Coronary Angiography

NCT07889479 | Completed DMC

• 1 other identifier: HE-STRESSBALL-CAG-2024
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

This study aimed to evaluate the effects of using a stress ball during femoral catheter removal on quality of recovery, patient comfort, and pain in adults undergoing coronary angiography. The study was conducted at a hospital in Istanbul, Türkiye, between November 2024 and May 2025. A total of 84 patients participated in this randomized controlled trial. Participants were randomly assigned to one of two groups, with 42 patients in each group. Patients in the intervention group were asked to repeatedly squeeze and release a stress ball during femoral catheter removal. Patients in the control group received routine clinical care without the stress ball intervention. Pain was assessed 15 minutes after catheter removal. Quality of recovery and patient comfort were evaluated before discharge using standardized assessment scales. The study was designed to determine whether stress ball use could improve recovery and comfort and reduce pain during care following coronary angiography.

Conditions

Coronary Angiography

Keywords

Coronary Angiography; Femoral Catheter Removal; Stress Ball; Quality of Recovery; Patient Comfort; Pain Management

Outcome Measures

Primary Outcomes (1)

• Quality of Recovery Score

  Quality of recovery was assessed using the Quality of Recovery Scale, developed by Stark et al. (2013) and validated in Turkish by Kılıç et al. (2023). Higher total scores indicate better quality of recovery. Total scores were compared between the stress ball intervention group and the routine care group.

  Before hospital discharge

Secondary Outcomes (2)

• Perianesthesia Comfort Score

  Before hospital discharge

• Pain Intensity Measured by the Numeric Rating Scale

  15 minutes after femoral catheter removal

Study Arms (2)

Stress Ball Group

EXPERIMENTAL

Participants in the intervention group received routine clinical care and were instructed to use a medium-sized, medium-firm silicone stress ball during femoral catheter removal following coronary angiography. Participants repeatedly squeezed the stress ball while counting to three and then released it, continuing this procedure during catheter removal.

Other: Stress Ball Intervention

Control Group

NO INTERVENTION

Participants in the control group received routine clinical care during femoral catheter removal following coronary angiography. No stress ball intervention was administered. Pain intensity was assessed 15 minutes after catheter removal, while quality of recovery and perianesthesia comfort were evaluated before discharge.

Interventions

Stress Ball Intervention OTHER

Participants assigned to the intervention group were instructed to use a medium-sized, medium-firm silicone stress ball during femoral catheter removal following coronary angiography. Participants repeatedly squeezed the stress ball while counting to three and then released it. This procedure was continued during catheter removal as a non-pharmacological nursing intervention. All participants also received routine clinical care.

Stress Ball Group

Eligibility Criteria

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

You may qualify if:

• Aged 18 years or older.
• No communication difficulties that would prevent participation in the study.
• Adequate mental status to participate in the study.
• No physical limitations preventing the use of a stress ball.
• Underwent coronary angiography via femoral arterial access.
• No complications during the coronary angiography procedure.
• Voluntary agreement to participate in the study and provision of written informed consent.

You may not qualify if:

• Requesting withdrawal from the study at any stage.
• Being discharged before completion of data collection.
• Developing complications during the intervention or data collection process.

Sponsors & Collaborators

• Maltepe University: lead

Study Sites (1)

Maltepe University

Istanbul, Istanbul, 0000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Hatice Erdoğan

  Maltepe University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assist Prof

Model Details: This study was designed as a single-center, two-arm, parallel-group randomized controlled trial. A total of 84 participants were randomly assigned in a 1:1 ratio to either the intervention group (n=42), which received a stress ball intervention during femoral catheter removal, or the control group (n=42), which received routine clinical care. Each participant remained in their assigned group throughout the study, with no crossover between groups.

Study Record Dates

• First Submitted: October 15, 2026
• First Posted: October 22, 2026
• Study Start: May 30, 2025
• Primary Completion: November 28, 2025
• Study Completion: November 28, 2025
• Last Updated: October 22, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)