Vascular AccessNCT07679295
Port Catheter Needle Change: Pain, Anxiety and Patient Satisfaction
A study testing Stress ball in people with Vascular Access, run by Kahramanmaras Sutcu Imam University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vascular Access
- What is being tested?
- Stress ball
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 29 Jun 2026to 29 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Şanlıurfa Mehmet Akif İnan Education and Research Hospital
Sanliurfa
About this study
Official title: 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.
- Conditions
- Vascular Access
- Being tested
- Stress ball
- Keywords
- Vascular Access Devices, pain, anxiety, patient satisfaction
- Medical subject headings
- Pain, Anxiety Disorders, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stress ballBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | This is control group |
| Stress ball | Experimental | experimenal group Receives: Behavioral: Stress ball |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: On the day of port catheter needle replacement, prior to the procedure
Secondary outcomes (3)
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".
Measured: 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.
Measured: 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.
Measured: Data will be collected within 15 minutes after completion of port catheter needle replacement.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2026
- Study start29 Jun 2026 (estimated)
- Primary completion29 Aug 2026 (estimated)
- Study completion29 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vascular AccessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kahramanmaras Sutcu Imam University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, SERAP GÜNGÖR ÜNAL, Kahramanmaras Sutcu Imam University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07679295
- Sponsor's protocol ID
- Port
- Status last verified
- Jun 2026
- First submitted
- 19 Jun 2026
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Stress Ball Application During Port Catheter Needle Change on Pain, Anxiety, and Patient Satisfaction: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT07679295
- Acronym / sponsor ID
- Port
- Conditions
- Vascular Access
- Keywords
- Vascular Access Devices, pain, anxiety, patient satisfaction
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Kahramanmaras Sutcu Imam UniversityUniversity, hospital or other
- Study start
- 29 Jun 2026 (estimated)
- Primary completion
- 29 Aug 2026 (estimated)
- Study completion
- 29 Sep 2026 (estimated)
- First posted
- 1 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –This is control group |
| Stress ball | Experimental | Behavioral: Stress ballexperimenal group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stress ballAfter 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. | Behavioural | Stress ball |
Primary outcome
Patient-reported information and state anxiety level before port catheter needle replacement
Time frame: On the day of port catheter needle replacement, prior to the procedure
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.
3 secondary outcomes
Pain intensity after port catheter needle replacement
Time frame: Data will be collected within 15 minutes after completion of port catheter needle replacement.
Patient satisfaction after port catheter needle replacement
Time frame: Data will be collected within 15 minutes after completion of port catheter needle replacement
State anxiety level after port catheter needle replacement
Time frame: Data will be collected within 15 minutes after completion of port catheter needle replacement.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2026.
Related trials for Vascular Access
Active, not recruiting
Compassionate-Use of 4% T-EDTA Lock Solution for Central Venous Lines of Pediatric PN Patients
Central Line Complication, Central Line-associated Bloodstream Infection (CLABSI)
RecruitingPhase 3
A Study Providing Treatment Access in Participants With Pulmonary Hypertension Completing a Parent Study and Having no Other Option
Hypertension, Pulmonary
Enrolling by invitation
TruVascular Access - Ultrasound-Guided Vascular Access Study
Peripheral Venous Catheterization, Difficult Intravenous Access
Not yet recruiting
Impact of a Long Peripheral Venous Catheter Protocol in Pediatric and Neonatal Care
Vascular Access Devices, Vascular Access
Recruiting
DIStal Versus COnventional Radial Access for COMPLEX Large-bore Percutaneous Coronary Intervention
Vascular Access Site Occlusion
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stress ball in people with Vascular Access, run by Kahramanmaras Sutcu Imam University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient-reported information and state anxiety level before port catheter needle replacement (time frame: On the day of port catheter needle replacement, prior to the procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2026.