Port Catheter Needle Change: Pain, Anxiety and Patient Satisfaction

The Effect of Stress Ball Application During Port Catheter Needle Change on Pain, Anxiety, and Patient Satisfaction: A Randomized Controlled Study

Port catheters play a significant role in the management of cancer patients and eliminate the need for serial peripheral access by reducing patient anxiety associated with repeated venous punctures.

In particular, inserting the needle into a subcutaneous port can be painful, frightening, and uncomfortable, even when the skin is numbed with a local anesthetic. Therefore, this study aims to investigate the effects of stress ball use on pain, anxiety, and patient satisfaction during port catheter needle changes in oncology patients.

Study Overview

• Status: Enrolling by invitation
• Conditions: Vascular Access
• Intervention / Treatment: Behavioral: Stress ball

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Sanliurfa, Turkey (Türkiye)
    • Şanlıurfa Mehmet Akif İnan Education and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Being over 18 years of age,
• Receiving treatment and care in the oncology ward,
• Having the hand function to physically use a stress ball,
• Patients who volunteer to participate in the study will be included.

Exclusion Criteria:

• Patients who cannot be communicated with,
• Those with peripheral neuropathic complaints,
• Those with psychiatric diagnoses,
• Patients who refuse to participate in the study will not be included.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control Group; This is control group
Experimental: Stress ball; experimenal group	Behavioral: Stress ball; After randomization, patients assigned to the intervention group will be informed about the study beforehand and their informed consent will be obtained. Subsequently, each patient will be given both theoretical and practical instructions on how to use the stress ball, and will be asked to practice. Patients will be given individual stress balls approximately 6 cm in diameter, of medium firmness, and made of medical-grade silicone. Patients who successfully use the stress ball will be instructed to take deep breaths, squeeze the stress ball in their hands, and exhale to release it for approximately 5-10 minutes during the port catheter change procedure. The practice will be observed by the researcher to ensure standardization. Throughout the study, all port catheter changes will be performed by the same nurse in the clinic, who is not involved in the study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient-reported information and state anxiety level before port catheter needle replacement	The State Anxiety Scale is a 20-item, 4-point Likert-type scale designed to determine how an individual feels at a given moment and under specific conditions. In the State Anxiety Inventory, the individual is asked to rate how they feel "right now" and choose one of the following options based on the intensity of the emotion or behavior expressed in the items: (1) "none", (2) "a little", (3) "a lot", and (4) "completely". The highest score of 4 is given for choosing "completely", and the lowest score of 1 is given for choosing "none". The lowest possible total score on the State Anxiety Scale is 20, and the highest is 80. A high score indicates a high level of anxiety, while a low score indicates a low level of anxiety.	On the day of port catheter needle replacement, prior to the procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain intensity after port catheter needle replacement	Numerical Rating Scale The scale used to diagnose pain has numerical values between 0 and 10. The patient is asked to indicate their pain on the scale. During the evaluation, an 11-point scale was used, where "0" represents "no pain" and "10" represents "the most severe pain imaginable".	Data will be collected within 15 minutes after completion of port catheter needle replacement.
Patient satisfaction after port catheter needle replacement	Visual Analog Patient Satisfaction Scale The visual patient satisfaction scale (visual analog patient satisfaction scale) overlaps with the characteristics of the VAS. This scale is a vertical straight line between 0 and 10. "0" (Not satisfied at all), "10" (Very satisfied). The patient indicates the point on the vertical line corresponding to their degree of medical satisfaction with a cross mark and is scored out of ten.	Data will be collected within 15 minutes after completion of port catheter needle replacement
State anxiety level after port catheter needle replacement	The State Anxiety Scale is a 20-item, 4-point Likert-type scale designed to determine how an individual feels at a given moment and under specific conditions. In the State Anxiety Inventory, the individual is asked to rate how they feel "right now" and choose one of the following options based on the intensity of the emotion or behavior expressed in the items: (1) "none", (2) "a little", (3) "a lot", and (4) "completely". The highest score of 4 is given for choosing "completely", and the lowest score of 1 is given for choosing "none". The lowest possible total score on the State Anxiety Scale is 20, and the highest is 80. A high score indicates a high level of anxiety, while a low score indicates a low level of anxiety.	Data will be collected within 15 minutes after completion of port catheter needle replacement.

Collaborators and Investigators

• Sponsor: Kahramanmaras Sutcu Imam University

Study record dates

Study Major Dates

• Study Start (Estimated): June 29, 2026
• Primary Completion (Estimated): August 29, 2026
• Study Completion (Estimated): September 29, 2026

Study Registration Dates

• First Submitted: June 19, 2026
• First Submitted That Met QC Criteria: June 25, 2026
• First Posted (Actual): July 1, 2026

Study Record Updates

• Last Update Posted (Actual): July 1, 2026
• Last Update Submitted That Met QC Criteria: June 25, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: pain; anxiety; patient satisfaction; Vascular Access Devices
• Additional Relevant MeSH Terms: Neurologic Manifestations; Mental Disorders; Pathological Conditions, Signs and Symptoms; Behavior; Signs and Symptoms; Treatment Adherence and Compliance; Health Behavior; Pain; Anxiety Disorders; Patient Satisfaction
• Other Study ID Numbers: Port

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No