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

NCT05972811 | Unknown

• 1 other identifier: Karadeniz T. Uni.
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain

Keywords

Pain; Pain Management; Kidney Transplantation; Drainage; Cryotherapy

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (2)

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.

Other: Cold application

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.

Interventions

Cold application 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

Cold application

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Karadeniz Technical University: lead

Study Sites (1)

Karadeniz Technical University

Trabzon, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain; Agnosia

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Study Officials

• Dilek ÇİLİNGİR, Professor

  Karadeniz Technical University

  STUDY DIRECTOR

Central Study Contacts

Ufuk AKKURT, Master

CONTACT

+905462347351; akkurt8385@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: The application will be made by the researcher. However, pain assessment will be done by the nurse who cares for the patient.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD (c), Department of Nursing

Model Details: Prospective, parallel randomized controlled clinical trial

Study Record Dates

• First Submitted: July 25, 2023
• First Posted: August 2, 2023
• Study Start: September 1, 2023
• Primary Completion: March 1, 2024
• Study Completion: April 1, 2024
• Last Updated: August 9, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)