Pressurized Cold Application for Patients Total Knee Prosthesis Surgery

NCT05233423 | Completed DMC

• 1 other identifier: OBuldan
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Knee Prosthesis; Cryotherapy; Pain; Patient Satisfaction

Outcome Measures

Primary Outcomes (1)

• The change in pain level of total knee prothesis patients at 9 cold applicatiıon 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 Outcomes (1)

• 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.

Study Arms (2)

Intervention Group

EXPERIMENTAL

The patients in the intervention group were applied 9 cold applications with 30 mmHg pressure for 20 minutes and 40 minutes of rest.

Device: compressed cold therapy bandage

Control Group

NO INTERVENTION

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.

Interventions

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.

Intervention Group

Eligibility Criteria

• Age: 46 Years - 82 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• have a cold allergy
• have peripheral vascular disease
• diagnosed with Raynaud's disease
• have cognitive, affective and verbal communication problems

Sponsors & Collaborators

• Pamukkale University: lead

Study Sites (1)

Pamukkale University

Denizli, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain; Patient Satisfaction

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Single blinding was provided that included inclusion criteria and agreement to participate in the study.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Model Details: This study is a parallel group randomized controlled study

Study Record Dates

• First Submitted: December 28, 2021
• First Posted: February 10, 2022
• Study Start: July 1, 2019
• Primary Completion: February 1, 2020
• Study Completion: February 1, 2020
• Last Updated: February 10, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)