Port-A-CathNCT07002190
The Effect of Education Given Before Port Catheter Infusion on Infusion Related Symptoms
A study testing Watching an animation video in people with Port-A-Cath, run by Karadeniz Technical University at 1 site in Turkey (Türkiye).
Trial summary
Pain, anxiety, anxiety and changes in vital signs are observed in patients during needle insertion into the port catheter.Patients and their relatives should be informed by nurses to eliminate these problems and to provide more comfortable infusion to patients.However, studies on the care process for the symptoms that… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Port-A-Cath
- What is being tested?
- Watching an animation video
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 14 Feb 2024to 30 Sep 2025
- 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 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Having a port catheter
- The patient has no previous experience with a port catheter,
- The patient will receive an infusion from a port catheter for the first time,
- The patient's age range is between 18-70,
- The patient is literate,
- Volunteering to participate in the study,
- The patient will receive training from the training material for the first time.
Who cannot join
- Those with communication, hearing and vision problems,
- Those with any psychiatric disorder,
- Those who used any analgesic medication at least 8 hours before
Trial locations and contacts
1 site in 1 country.
About this study
Pain, anxiety, anxiety and changes in vital signs are observed in patients during needle insertion into the port catheter.Patients and their relatives should be informed by nurses to eliminate these problems and to provide more comfortable infusion to patients.However, studies on the care process for the symptoms that occur before port catheter infusion are limited in the literature.The thesis study planned for this purpose will be carried out to determine the effect of the training given before port catheter infusion on infusion-related symptoms.The research will be conducted as pretest-posttest, randomised controlled.Oncology-Hematology Services and Chemotherapy Unit of Karadeniz Technical University Farabi Hospital.The sample of the study will be determined by simple randomisation method and 64 patient will be included in the study.The data of the study will be collected by Patient Descriptive Information Form, Visual Analogue Scale and State and Trait Anxiety Scale, Vital Signs Follow-up Chart.
- Conditions
- Port-A-Cath
- Being tested
- Watching an animation video
- Keywords
- Pain, Anxiety, Education, Nursing, Port catheter
- Medical subject headings
- Pain, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Watching an animation videoOther
education
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | The Experimental group period with the support of visual education material Receives: Other: Watching an animation video |
| Control Group | No intervention | The control group will take rutin patient çare. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Identifying Information Form
This form, which was created by the researchers by reviewing the relevant literature, consists of 11 questions evaluating the descriptive characteristics of the patients the number of port catheter needle insertions and the information status about the port catheter.
Measured: 1 day
Secondary outcomes (2)
State and Trait Anxiety Scale
The scale, which is in the z-type evaluation type, consists of 2 subscales in the four-point Likert type and a total of 40 items. The answer options collected in four classes in the State Anxiety Scale include the expressions (1) Never, (2) A Little, (3) A Lot, (4) Completely, while the Trait Anxiety Scale includes four classes and includes the expressions (1) Almost never, (2) Sometimes, (3) A Lot, (4) Almost always.
Measured: 2 day
Symptom chart
This form is used to measure patients' vital signs, pain during the procedure, and anxiety.
Measured: 2 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2025
- Study start14 Feb 2024
- Primary completion30 Aug 2025 (estimated)
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Port-A-CathStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karadeniz Technical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yekta Demirsoy, Karadeniz Technical University
- Investigators
- Şule Bıyık Bayram, Assoc. Prof. Dr., Principal investigator, Karadeniz Technical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07002190
- Sponsor's protocol ID
- 2024-23
- Status last verified
- May 2025
- First submitted
- 10 May 2025
- Last updated
- 3 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Education Given Before Port Catheter Infusion on Infusion Related Symptoms
- ClinicalTrials.gov ID
- NCT07002190
- Acronym / sponsor ID
- 2024-23
- Conditions
- Port-A-Cath
- Keywords
- Pain, Anxiety, Education, Nursing, Port catheter
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Karadeniz Technical UniversityUniversity, hospital or other
- Study start
- 14 Feb 2024 (actual)
- Primary completion
- 30 Aug 2025 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 3 Jun 2025 (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.
Pain, anxiety, anxiety and changes in vital signs are observed in patients during needle insertion into the port catheter.Patients and their relatives should be informed by nurses to eliminate these problems and to provide more comfortable infusion to patients.However, studies on the care process for the symptoms that occur before port catheter infusion are limited in the literature.The thesis study planned for this purpose will be carried out to determine the effect of the training given before port catheter infusion on infusion-related symptoms.The research will be conducted as pretest-posttest, randomised controlled.Oncology-Hematology Services and Chemotherapy Unit of Karadeniz Technical University Farabi Hospital.The sample of the study will be determined by simple randomisation method and 64 patient will be included in the study.The data of the study will be collected by Patient Descriptive Information Form, Visual Analogue Scale and State and Trait Anxiety Scale, Vital Signs Follow-up Chart.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: Watching an animation videoThe Experimental group period with the support of visual education material |
| Control Group | No intervention | –The control group will take rutin patient çare. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Having a port catheter
- The patient has no previous experience with a port catheter,
- The patient will receive an infusion from a port catheter for the first time,
- The patient's age range is between 18-70,
- The patient is literate,
Key exclusion criteria (3 listed)
- Those with communication, hearing and vision problems,
- Those with any psychiatric disorder,
- Those who used any analgesic medication at least 8 hours before
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 |
|---|---|---|
| Watching an animation videoeducation | Other | Experimental group |
Primary outcome
Patient Identifying Information Form
Time frame: 1 day
This form, which was created by the researchers by reviewing the relevant literature, consists of 11 questions evaluating the descriptive characteristics of the patients the number of port catheter needle insertions and the information status about the port catheter.
2 secondary outcomes
State and Trait Anxiety Scale
Time frame: 2 day
Symptom chart
Time frame: 2 day
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 3 Jun 2025.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Şule Bıyık Bayram, Assoc. Prof. Dr. principal investigator
Karadeniz Technical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Watching an animation video in people with Port-A-Cath, run by Karadeniz Technical 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 7 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 3 Jun 2025. 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 Identifying Information Form (time frame: 1 day). 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 3 Jun 2025.