The Effect of Cold Application on Pain Developed Due to Drain Removal in Patients With Kidney Transplantation

August 5, 2023 updated by: Ufuk Akkurt, Karadeniz Technical University

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

76

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Turkey
      • Trabzon, Turkey
        • Karadeniz Technical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cold application
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.
Other: Cold application
In the experimental group, cold application will be made until the skin temperature of the drain exit area reaches 13.6 °C. And before drain removal, immediately after drain removal and 15 minutes later, pain levels will be measured with VAS and analgesic needs will be questioned
No Intervention: Control
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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karadeniz Technical University

Investigators

  • Study Director: Dilek ÇİLİNGİR, Professor, Karadeniz Technical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2023

Primary Completion (Estimated)

March 1, 2024

Study Completion (Estimated)

April 1, 2024

Study Registration Dates

First Submitted

July 25, 2023

First Submitted That Met QC Criteria

July 25, 2023

First Posted (Actual)

August 2, 2023

Study Record Updates

Last Update Posted (Actual)

August 9, 2023

Last Update Submitted That Met QC Criteria

August 5, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Karadeniz T. Uni.

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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