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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

Status
Enrolling by invitation
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07679295
Enrollment
50
Registered
2026-07-01
Start date
2026-06-29
Completion date
2026-09-29
Last updated
2026-07-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vascular Access

Keywords

Vascular Access Devices, pain, anxiety, patient satisfaction

Brief summary

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.

Interventions

BEHAVIORALStress 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.

Sponsors

Kahramanmaras Sutcu Imam University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Patient-reported information and state anxiety level before port catheter needle replacementOn the day of port catheter needle replacement, prior to the procedureThe 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.

Secondary

MeasureTime frameDescription
Pain intensity after port catheter needle replacementData will be collected within 15 minutes after completion of 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".
Patient satisfaction after port catheter needle replacementData will be collected within 15 minutes after completion of port catheter needle replacementVisual 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.
State anxiety level after port catheter needle replacementData will be collected within 15 minutes after completion of 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.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 2, 2026