Clinical trial NCT06816420: Effect Of Local Cold Applıcatıon On Paın and Vıtal Sıgns Durıng Port Catheter Needle Insertıon
Official title: Effect Of Local Cold Applıcatıon On Paın and Vıtal Sıgns Durıng Port Catheter Needle Insertıon
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Catheter Placement and Perceived Pain
Vital Sign Monitoring
Pain
Lead sponsor: Necmettin Erbakan University
Sponsor class: OTHER
First posted: 2025-02-10
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: one group will be applied cold application, and the other group will not.
Primary purpose: OTHER

Brief summary: In this study, the effect of cold application on the pain experienced during port catheter needle insertion and the change in the patient's vital signs will be evaluated. It is thought that with this application, patients will experience less pain during port catheter needle insertion. The change in the patient's vital signs and pain status will also be evaluated. The research will be conducted in the outpatient chemotherapy department of a Hospital.

Detailed description: The effects of lidocaine cream, cryotherapy (cold application to the skin), cutaneous stimulation therapy (pressure and massage) methods , virtual reality application and aromatherapy applied via inhalation on reducing pain were investigated in order to reduce the pain during port catheter needle insertion. In this study, the effect of cold application on the pain experienced during port catheter needle insertion and the change in the patient's vital signs will be evaluated. It is thought that with this application, patients will experience less pain during port catheter needle insertion. The change in the patient's vital signs according to the pain status will also be evaluated. The research will be conducted in the outpatient chemotherapy department of Necmettin Erbakan University Faculty of Medicine Hospital. The universe of the research will consist of all patients with port catheters in the outpatient chemotherapy department of Necmettin Erbakan University Faculty of Medicine Hospital. The sample of the research will consist of patients who meet the inclusion criteria and agree to participate in the research.

Eligibility criteria: Inclusion Criteria:

Patients between the ages of 18-65, who are pain-free, receiving treatment in an outpatient chemotherapy unit, who have a port catheter, who have a Huber port needle of L (large) 20 mm-20 gauge, and who can read and write in Turkish.

Exclusion Criteria:

Patients taking "oxaliplatin" Patients aged 65 and over Patients who have started using a port catheter but whose stitches have not yet healed Patients who have not passed 30 days since the port catheter was inserted Patients with any redness, swelling or tenderness in the port catheter area

Primary outcomes:
measure: Pain level
timeFrame: before and in ten minutes after cold application
measure: Vıtal Sıgns (blood pressure, mm/Hg)
timeFrame: before and in ten minutes after cold application
measure: Vıtal Sıgns (body temperature, Celcius degree)
timeFrame: before and in ten minutes after cold application
measure: Vıtal Sıgns (pulse rate in one minutes)
timeFrame: before and in ten minutes after cold application
measure: vital signs (saturation rate, %)
timeFrame: before and in ten minutes after cold application
Secondary outcomes:
Other outcomes:
Locations:
city: Konya
country: Turkey
facility: Necmettin Erbakan University
state: Meram
Study officials:
affiliation: Necmettin Erbakan University
name: Gülden Basit, Assoc. Prof.
role: PRINCIPAL_INVESTIGATOR
References: