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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05233423
Other study ID # OBuldan
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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.
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