Pressurized Cold Application for Patients Total Knee Prosthesis Surgery

NCT ID: NCT05233423

Last Updated: 2022-02-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-01

Study Completion Date

2020-02-01

Brief Summary

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

Detailed Description

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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.

Conditions

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Knee Prosthesis Cryotherapy Pain Patient Satisfaction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This study is a parallel group randomized controlled study
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants
Single blinding was provided that included inclusion criteria and agreement to participate in the study.

Study Groups

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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.

Group Type EXPERIMENTAL

compressed cold therapy bandage

Intervention Type DEVICE

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.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

46 Years

Maximum Eligible Age

82 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Pamukkale University

OTHER

Sponsor Role lead

Responsible Party

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Özge Buldan

Research Assistant

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Pamukkale University

Denizli, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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OBuldan

Identifier Type: -

Identifier Source: org_study_id

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