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

NCT ID: NCT05972811

Last Updated: 2023-08-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 76 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-01
• Study Completion Date: 2024-04-01

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.

Conditions

Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Cold application

Intervention Type: OTHER

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

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Karadeniz Technical University

OTHER

Sponsor Role: lead

Responsible Party

Ufuk Akkurt

PhD (c), Department of Nursing

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dilek ÇİLİNGİR, Professor

Role: STUDY_DIRECTOR

Karadeniz Technical University

Locations

Karadeniz Technical University

Trabzon, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Central Contacts

Ufuk AKKURT, Master

Role: CONTACT

akkurt8385@gmail.com

+905462347351

Facility Contacts

Ufuk AKKURT, Master

Role: primary

akkurt8385@gmail.com

+905462347351

Other Identifiers

Karadeniz T. Uni.

Identifier Type: -

Identifier Source: org_study_id