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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05972811
• Other study ID #: Karadeniz T. Uni.
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 1, 2023
• Est. completion date: April 1, 2024

Study information

• Verified date: August 2023
• Source: Karadeniz Technical University
• Contact: Ufuk AKKURT, Master
• Phone: +905462347351
• Email: akkurt8385[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 76
• Est. completion date: April 1, 2024
• Est. primary completion date: March 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pain

Intervention

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

Locations

Country	Name	City	State
Turkey	Karadeniz Technical University	Trabzon

Sponsors (1)

Lead Sponsor	Collaborator
Karadeniz Technical University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain evaluated using the Visual Analog Scale (VAS)	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.