Pressurized Cold Application for Patients Total Knee Prosthesis Surgery

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05233423
• Other study ID #: OBuldan
• Status: Completed
• Phase: N/A
• Start date: July 1, 2019
• Est. completion date: February 1, 2020

Study information

• Verified date: December 2021
• Source: Pamukkale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: February 1, 2020
• Est. primary completion date: February 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 46 Years to 82 Years

Eligibility

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

Related Conditions & MeSH terms

• Cryotherapy
• Knee Prosthesis
• Pain
• Patient Satisfaction

Intervention

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.

Locations

Country	Name	City	State
Turkey	Pamukkale University	Denizli

Sponsors (1)

Lead Sponsor	Collaborator
Pamukkale University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The change in pain level of total knee prothesis patients at 9 cold applicatiion 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	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.