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

NCT06262022 | Recruiting DMC

• 1 other identifier: KaramanogluMehmetbeyUFGok
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Cold Therapy; Pain, Postoperative

Keywords

cold therapy; pain; patient; knee arthroplasty

Outcome Measures

Primary Outcomes (1)

• pain level

  Pain level of patients will be measured after total knee arthroplasty ( Visual Analogue Scale (VAS) is a 10 cm ruler with "no pain" written on one end and "the worst possible pain" written on the other end. Patients mark the levels on the ruler according to their pain levels. 1-3 points on the scale are rated as mild, 4-6 points as moderate and 7-10 points as severe pain.)

  After total knee arthroplasty, pain intensity will be evaluated at the 6th, 24th and 48th hours.

Secondary Outcomes (2)

• edema

  Knee circumference measurements for knee edema will be made before total knee arthroplasty and at the 24th and 48th hours after total knee arthroplasty.

• amount of drainage

  After being taken to bed after total knee arthroplasty, the amount of drainage will be measured at the 1st, 6th and 24th hours.

Other Outcomes (1)

• Analgesic consumption

  The first 24 hours and 24-48 hours after total knee arthroplasty. Analgesic consumption between hours will be recorded.

Study Arms (2)

experimental arm

EXPERIMENTAL

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.

Other: cold therapy

control arm

NO INTERVENTION

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.

Interventions

cold therapy 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.

experimental arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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,

You may not qualify if:

• 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,

Sponsors & Collaborators

• Karamanoğlu Mehmetbey University: lead
• Karaman Training and Research Hospital: collaborator

Study Sites (1)

Karamanoğlu Mehmet bey Üniversitesi

Merkez, Karaman, 70100, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative; Pain

Interventions

Cryotherapy

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics

Central Study Contacts

fatma gök

CONTACT

05544906142; fatmagok123@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer

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

Study Record Dates

• First Submitted: January 30, 2024
• First Posted: February 15, 2024
• Study Start: January 15, 2024
• Primary Completion: April 30, 2024
• Study Completion: April 30, 2024
• Last Updated: February 15, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)