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Completed

NCT Number: NCT05233423

Pressurized Cold Application for Patients Total Knee Prosthesis Surgery

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

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Key information

Conditions

Knee Prosthesis Behavior Cryotherapy Health Behavior Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Patient Satisfaction Signs and Symptoms Treatment Adherence and Compliance

Age range

46 year–82 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pamukkale University

Denizli, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

compressed cold therapy bandage

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.

Primary outcomes

  1. The change in pain level of total knee prothesis patients at 9 cold applicatiıon with Visual Analog Scale.

    Time frame: 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 outcomes

  1. The level of satisfaction of patients with the type of cold application applied

    Time frame: ,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)

Sponsors and collaborators

Lead sponsor

Pamukkale University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Feb 10, 2022
Registry last updated
Feb 10, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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