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

Sponsor

Karadeniz Technical University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05972811

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

10.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pain	Other: Cold application	N/A

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

Anticipated Enrollment :

76 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Prospective, parallel randomized controlled clinical trialProspective, parallel randomized controlled clinical trial

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.

Primary Purpose:

Supportive Care

Official Title:

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

Anticipated Study Start Date :

Sep 1, 2023

Anticipated Primary Completion Date :

Mar 1, 2024

Anticipated Study Completion Date :

Apr 1, 2024

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Pain evaluated using the Visual Analog Scale (VAS) [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Karadeniz Technical University	Trabzon		Turkey

Sponsors and Collaborators

Karadeniz Technical University

Investigators

Study Director: Dilek ÇİLİNGİR, Professor, Karadeniz Technical University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ufuk Akkurt, PhD (c), Department of Nursing, Karadeniz Technical University

ClinicalTrials.gov Identifier:

NCT05972811

Other Study ID Numbers:

Karadeniz T. Uni.

First Posted:

Aug 2, 2023

Last Update Posted:

Aug 9, 2023

Last Verified:

Aug 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Ufuk Akkurt, PhD (c), Department of Nursing, Karadeniz Technical University

Pain

Pain Management

Kidney Transplantation

Drainage

Cryotherapy

Study Results

No Results Posted as of Aug 9, 2023