The Effect of Cold Application on Pain Level, Edema and Drainage Amount

NCT ID: NCT06262022

Last Updated: 2024-02-15

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

RECRUITING

Clinical Phase

NA

Total Enrollment

78 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-15

Study Completion Date

2024-04-30

Brief Summary

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In this study, we aimed to investigate the effect of cold application applied for 20 minutes every hour for 8 hours on the first day, second and third days after total hip arthroplasty with gel pads, on the pain level, edema and drainage amount of total hip arthroplasty patients. The main question\[s\]it aims to answer are:

* Is there a difference between the pain levels of patients in the control and cold application arms?
* Is there a difference between the knee edema of patients in the control and cold application arms?
* Is there a difference between the amount of drainage of patients in the control and cold application arms? This study was planned as a prospective, parallel, two-arm (1:1) randomized controlled trial (RCT).

Detailed Description

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* When the patient arrives at the service after TKA, cold application will begin with gel pads at 0 ºC and continue for eight hours. After TKA, cold application will continue for 20 minutes every hour between 08.00-16.00 on the 1st and 2nd day.
* After TKA, pain intensity will be evaluated and at the 6th, 24th and 48th hours.
* Knee circumference measurements for knee edema will be made before TKA and at the 24th and 48th hours after TKA.
* After being taken to bed after TKA, the amount of drainage will be measured at the 1st, 6th and 24th hours.
* In the first 24 hours and 24-48 hours after TKA. Analgesic consumption between hours will be recorded.
* Knee temperature will be measured before and after each cold application.
* Knee temperature will be measured before and after each cold application. Measurements of the control group will be made at the specified times in the cold application group. Cold application will not be applied to the control group.

Conditions

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Cold Therapy Pain, Postoperative

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This study was planned as a prospective, parallel, two-arm (1:1) randomized controlled trial (RCT).
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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experimental arm

A cold ice pack will be applied to the patient's knee for 20 minutes every hour for three days, starting after total knee arthroplasty.

Group Type EXPERIMENTAL

cold therapy

Intervention Type OTHER

A cold ice pack will be applied to the patient's knee for 20 minutes every hour for three days, starting after total knee arthroplasty.

control arm

Only unit-specific routine treatment and care interventions will be applied to the patients in the control arm by the team in the unit, and no intervention will be applied by the researcher.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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cold therapy

A cold ice pack will be applied to the patient's knee for 20 minutes every hour for three days, starting after total knee arthroplasty.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 18 years and above,
* Able to communicate verbally and in writing,
* Turkish speaking,
* TKA applied for the first time,
* Unilateral total knee arthroplasty applied,
* Spinal anesthesia applied,
* Having a hemovac drainage catheter,
* Without peripheral vascular disease,

Exclusion Criteria

* Revision total knee arthroplasty applied,
* Bilateraltotal knee arthroplasty applied,
* Those who use alcohol and substances,
* TKA was performed for a reason other than knee osteoarthritis,
* General anesthesia applied,
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Karaman Training and Research Hospital

OTHER

Sponsor Role collaborator

Karamanoğlu Mehmetbey University

OTHER

Sponsor Role lead

Responsible Party

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Fatma GÖK

lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Karamanoğlu Mehmet bey Üniversitesi

Merkez, Karaman, Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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fatma gök

Role: CONTACT

05544906142

Facility Contacts

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fatma gök

Role: primary

05544906142

Other Identifiers

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KaramanogluMehmetbeyUFGok

Identifier Type: -

Identifier Source: org_study_id

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