Pressurized Cold Application for Patients Total Knee Prosthesis Surgery

Not Applicable

Completed

• Conditions: Knee Prosthesis; Pain; Patient Satisfaction; Cryotherapy
• Interventions: Device: compressed cold therapy bandage

• Registration Number: NCT05233423
• Lead Sponsor: Pamukkale University

Brief Summary

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

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 Timeline

• Study Start: 2019-07-01
• Primary Completion: 2020-02-01
• Study Completion: 2020-02-01
• Status Verified: 2021-12
• Study First Submitted: 2021-12-28
• Study First Submitted QC: 2022-01-31
• Last Update Submitted: 2022-01-31
• Study First Posted: 2022-02-10
• Last Update Posted: 2022-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention Group	compressed cold therapy bandage	The patients in the intervention group were applied 9 cold applications with 30 mmHg pressure for 20 minutes and 40 minutes of rest.

Primary Outcome Measures

Name	Time	Method
The change in pain level of total knee prothesis patients at 9 cold applicatiıon with Visual Analog Scale.	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.	This scale was used horizontally before and after 9 cold applications to measure the pain level of the patients.

Secondary Outcome Measures

Name	Time	Method
The level of satisfaction of patients with the type of cold application applied	,The patient was asked once before discharge (about 1 day after surgery), the level of satisfaction with the type of cold application.	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)

Trial Locations

Locations (1)

Pamukkale University; 🇹🇷 Denizli, Turkey