Pressurized Cold Application for Patients Total Knee Prosthesis Surgery

The Effect of Pressurized Cold Application on Pain Level in Patients Wıth Total Knee Prosthesis Surgery

This study was conducted to examine the effects of pressurized cold applicatıon for patients total knee prosthesis surgery.

Study Overview

• Status: Completed
• Conditions: Pain; Patient Satisfaction; Knee Prosthesis; Cryotherapy
• Intervention / Treatment: Device: compressed cold therapy bandage

Detailed Description

The study was conducted as a randomized controlled experimental study in order to determine the effect of pressurized cold application applied after total knee replacement surgery on the level of pain and satisfaction.This study was conducted in 52 patients who applied to Pamukkale University Hospitals Orthopedics and Traumatology Clinic between July 2019 and February 2020, who met the inclusion criteria and accepted to participate in the study. The patients were divided into 26 in the control group (cold gel) and 26 in the study group (compressed cold therapy bandage) using a simple randomization method. The patients in the control group received 9 cold applications, in the form of 20 minutes of application and 40 minutes of rest after surgery. The patients in the study group were applied 9 cold applications with 30 mmHg pressure for 20 minutes and 40 minutes of rest.

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Denizli, Turkey
    • Pamukkale University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 46 years to 82 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 18 Years and older
• TDP surgery is planned to be performed by the same physician according to the rapid recovery protocol
• volunteer to participate in research
• had no problems in communicating cognitively, emotionally and verbally were included.

Exclusion Criteria:

• have a cold allergy
• have peripheral vascular disease
• diagnosed with Raynaud's disease
• have cognitive, affective and verbal communication problems

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Group; The patients in the intervention group were applied 9 cold applications with 30 mmHg pressure for 20 minutes and 40 minutes of rest.	Device: compressed cold therapy bandage; Compressed cold therapy bandage was applied by wrapping the operated knee of the patients. The patients in the intervention group received 9 cold applications with 30 mmHg pressure for 20 minutes and 40 minutes of rest.
No Intervention: Control Group; The patients in the control group were applied 9 times of cold gel in the form of 20 minutes of application and 40 minutes of rest after surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The change in pain level of total knee prothesis patients at 9 cold applicatiıon with Visual Analog Scale.	This scale was used horizontally before and after 9 cold applications to measure the pain level of the patients.	According to the fast track protocol, a total of 9 cold applications were applied to the patients who stayed in the service for an average of 1 day after the operation, except during sleep and physical therapy times.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The level of satisfaction of patients with the type of cold application applied	Satisfaction of the patients with the type of cold application applied was evaluated with a 4-point Likert question before discharge. (Very Satisfied, Satisfied, Neutral, Dissatisfied)	,The patient was asked once before discharge (about 1 day after surgery), the level of satisfaction with the type of cold application.

Collaborators and Investigators

• Sponsor: Pamukkale University

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2019
• Primary Completion (Actual): February 1, 2020
• Study Completion (Actual): February 1, 2020

Study Registration Dates

• First Submitted: December 28, 2021
• First Submitted That Met QC Criteria: January 31, 2022
• First Posted (Actual): February 10, 2022

Study Record Updates

• Last Update Posted (Actual): February 10, 2022
• Last Update Submitted That Met QC Criteria: January 31, 2022
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: OBuldan

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