Clinical trial NCT05972811: The Effect of Cold Application on Pain Developed Due to Drain Removal in Patients With Kidney Transplantation
Official title: Investigation of the Effect of Cold Application on Pain Caused by Jackson Pratt Drain Removal in Patients With Kidney Transplantation
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Pain
Keywords: Pain
Pain Management
Kidney Transplantation
Drainage
Cryotherapy
Lead sponsor: Karadeniz Technical University
Sponsor class: OTHER
First posted: 2023-08-02
Enrollment: 76
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: Prospective, parallel randomized controlled clinical trial
Primary purpose: SUPPORTIVE_CARE

Brief summary: The study was planned as a prospective, randomized controlled study to examine the effect of cold application on pain due to Jackson Pratt drain removal in kidney transplant patients.

Detailed description: During kidney transplant surgery, a Jackson Pratt Drain (JP) is placed in the surgical field to monitor lymphocele and urinary leakage. This drain is a closed system that opens outward from the skin at a point close to the incision line. This drain is removed by pulling when the drainage amount falls below 30 ml. This procedure is known to cause serious pain. In our study, which was planned as a prospective, randomized controlled study, it was aimed to examine the effect of cold application in the pain caused by the removal of the JP drain in patients with kidney transplantation. The population of the study will be patients who had a kidney transplant in İstinye University Hospital Liv Hospital Organ Transplant Center (n=76). In the study, patients will be assigned to the experimental and control groups by the block randomization method. "Patient Information Form" and "Visual Analog Scale" (VAS) will be used as data collection tools. In the experimental group, cold application will be made until the skin temperature of the drain exit area reaches 13.6 °C. Then, the drain removal process will be performed by the physician. In the control group, no application will be made. In both study groups before drain removal, immediately after drain removal and 15 minutes later, pain levels will be measured with VAS and analgesic needs will be questioned. Chi-square and t-tests will be used to compare demographic data in the analysis process of the data. ANOVA test will be applied to compare pain scores between groups.

Eligibility criteria: Inclusion Criteria:

* Being between the ages of 18-65,
* Being conscious, oriented to person, place and time,
* No history of mental pathology,
* No history of drug or alcohol use,
* Having a body mass index of \<30 kg/m2,
* Not using any analgesic or sedative medication one hour before drain removal.

Exclusion Criteria:

* IV analgesic or sedative treatment during cold application,
* Having a history of chronic pain,
* Having previous drain removal experience,
* Anxiety,
* Refusal to participate in the research,
* Unstable hemodynamic status.

Primary outcomes:
measure: Pain evaluated using the Visual Analog Scale (VAS)
timeFrame: Pain measurement will be made with VAS just before drain removal, immediately after drain removal, and 15 minutes later.
Secondary outcomes:
Other outcomes:
Locations:
city: Trabzon
country: Turkey
facility: Karadeniz Technical University
Study officials:
affiliation: Karadeniz Technical University
name: Dilek ÇİLİNGİR, Professor
role: STUDY_DIRECTOR
References: