NCT07002190

Brief 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 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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2024

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 14, 2024

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

May 10, 2025

Completed
24 days until next milestone

First Posted

Study publicly available on registry

June 3, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2025

Completed
Last Updated

June 3, 2025

Status Verified

May 1, 2025

Enrollment Period

1.5 years

First QC Date

May 10, 2025

Last Update Submit

May 24, 2025

Conditions

Keywords

PainAnxietyEducationNursingPort catheter

Outcome Measures

Primary Outcomes (1)

  • 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.

    1 day

Secondary Outcomes (2)

  • State and Trait Anxiety Scale

    2 day

  • Symptom chart

    2 day

Study Arms (2)

Experimental group

EXPERIMENTAL

The Experimental group period with the support of visual education material

Other: Watching an animation video

Control Group

NO INTERVENTION

The control group will take rutin patient çare.

Interventions

education

Experimental group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Those with communication, hearing and vision problems,
  • Those with any psychiatric disorder,
  • Those who used any analgesic medication at least 8 hours before

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karadeniz Technical University

Trabzon, 61800, Turkey (Türkiye)

Location

MeSH Terms

Conditions

PainAnxiety Disorders

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Study Officials

  • Şule Bıyık Bayram, Assoc. Prof. Dr.

    Karadeniz Technical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
nurse

Study Record Dates

First Submitted

May 10, 2025

First Posted

June 3, 2025

Study Start

February 14, 2024

Primary Completion

August 30, 2025

Study Completion

September 30, 2025

Last Updated

June 3, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations