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Clinical Trials/NCT05972811
NCT05972811Not yet recruitingNot Applicable

Investigation of the Effect of Cold Application on Pain Caused by Jackson Pratt Drain Removal in Patients With Kidney Transplantation

Karadeniz Technical University1 site in 1 country76 target enrollmentStarted: September 1, 2023Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
76
Locations
1
Primary Endpoint
Pain evaluated using the Visual Analog Scale (VAS)

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
Single (Care Provider)

Masking Description

The application will be made by the researcher. However, pain assessment will be done by the nurse who cares for the patient.

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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,
  • Refusal to participate in the research,
  • Unstable hemodynamic status.

Arms & Interventions

Cold application

Experimental

A frozen ice pack at -10 °C will be prepared for the patients in the experimental group. With these ice packs, the JP will be cooled to 13.6 °C, taking into account the literature, in order to create a local anesthetic effect on the drain outlet area before the drain is removed. Skin temperature will be measured intermittently with an infrared thermometer. When the skin temperature reaches 13.6 °C, the doctor will be informed and the drain will be removed. Before starting the cold application, immediately after the drain is removed, and after 15 minutes, considering the literature, pain will be measured with the "Visual Analog Scale". By ensuring that the drain removal procedure is performed by the same physician, individual differences that may arise will be prevented.

Intervention: Cold application (Other)

Control

No Intervention

No treatment will be applied to the patients in the control group. Pain measurement will be made with Visual Analog Scale before drain removal, immediately after drain removal, and 15 minutes later.

Outcomes

Primary Outcomes

Pain evaluated using the Visual Analog Scale (VAS)

Time Frame: Pain measurement will be made with VAS just before drain removal, immediately after drain removal, and 15 minutes later.

According to this scale, "0" indicates no pain, "1-4" indicates mild pain, "5-6" indicates moderate pain, and "7-10" indicates severe pain.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Ufuk Akkurt

PhD (c), Department of Nursing

Karadeniz Technical University

Study Sites (1)

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