Effect of Cold Immersion on Patients With Varicose Vein

Not Applicable

Not yet recruiting

• Conditions: Varicose Veins of Lower Limb
• Interventions: Other: Cold water immersion

• Registration Number: NCT05930587
• Lead Sponsor: Gazi University

Brief Summary

In the literature, it is stated that cold water immersion to lower extremities is effective on the symptoms of the disease. Studies have shown that cold water immersion, which is one of the cold application methods, has effects on increasing joint mobility, reducing pain, reducing stress, anxiety, depression, and increasing quality of life etc.

For this reason, the study is planned as a randomized controlled interventional study to determine the effect of cold water immersion directly to the lower extremity in the preoperative period of patients with varicose veins on quality of life, anxiety and symptoms experienced.

Detailed Description

The experimental group will be informed about the lower extremity cold immersion bath during the outpatient clinic controls and will be given a liquid meter digital thermometer that will allow them to check the cold water temperature at home. Patients will then be asked to do the lower extremity cold water immersion bath every day in their own home, for a total of four weeks, lasting 20 minutes in the evening before going to sleep.

It is recommended that the cold water immersion for 20 minutes and the temperature of the water should be 15 0C for it to be effective on the symptoms.

At the end of four weeks, patients will be informed that they should come to the outpatient clinic again. When the patients come to the outpatient clinic, information about the application will be repeated and data collection forms will be applied by face-to-face interview method.

To the patients in the control group; during the research process, routine outpatient controls will be made and no attempt will be made during the research.

Study Timeline

• Study First Submitted: 2023-06-13
• Study First Submitted QC: 2023-06-30
• Study First Posted: 2023-07-05
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-22
• Study Start: 2023-09-25
• Last Update Posted: 2023-09-25
• Primary Completion: 2023-10-25
• Study Completion: 2024-03-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Those between the ages of 18-65
• Those who have been diagnosed with lower extremity varicose disease for at least 1 year
• Those who have not had previous surgery due to varicose veins
• No visual, hearing and sensory impairment/neurosensor disorder problem
• No mental status disorder
• With intact skin integrity and no open wounds
• No circulatory disorder

Exclusion Criteria

• The patient has a known cold allergy or hypersensitivity to cold
• Patient having surgery during the study
• The patient's desire to withdraw from the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cold water immersion	Cold water immersion	The experimental group will be informed about the lower extremity cold immersion bath during the outpatient clinic controls and will be given a liquid meter digital thermometer that will allow them to check the cold water temperature at home. Patients will then be asked to do the lower extremity cold water immersion bath every day in their own home, for a total of four weeks, lasting 20 minutes in the evening before going to sleep. It is recommended that the cold dip bath last for 20 minutes and the temperature of the water should be 15 0C for it to be effective on the symptoms. At the end of four weeks, patients will be informed that they should come to the outpatient clinic again. When the patients come to the outpatient clinic, information about the application will be repeated and data collection forms will be applied by face-to-face interview method.

Primary Outcome Measures

Name	Time	Method
The Patient Questionnaire	four weeks	This form was created by the researcher based on the literature. This form consists of questions which sociodemographic characteristics (age, gender, body mass index, marital status, living people, educational status, employment status, economic status), characteristics of health status (presence of chronic diseases, drugs used regularly, smoking and alcohol use), characteristics of varicose disease (how many years have varicose veins, which leg has varicose veins, family history of varicose veins, previous surgery for varicose veins and use of varicose stockings), and physical symptoms experienced due to varicose veins (expected to score according to 0-10 evaluation scale). according to the characteristics (how many years have varicose disease, which leg has varicose veins, family history of varicose veins, previous surgery for varicose veins and using varicose stockings).

Secondary Outcome Measures

Name	Time	Method
VEINES-QOL/Sym	four weeks	VEINES-QOL/Sym is a standardised, 26-item, patient-reported questionnaire to assess the severity and frequency of venous insufficiency symptoms (questions 1,7; 10 items: heaviness, pain, leg swelling, night cramps, fatigue, burning sensation, throbbing sensation, itching, numbness in the legs, pain intensity), time of day when the symptoms are most pronounced (1 item, question 2), changes in the severity of symptoms during the past year (1 item, question 3), limitations in daily activities associated with venous insufficiency (9 item, questions 4,5,6), and the psychological impact on the functional status of patients with venous insufficiency measured during the previous 4 weeks (5 items, question 8). The scores are transformed as described in (14); the higher the result the better the quality of life.

Trial Locations

Locations (1)

Nevra Kalkan; 🇹🇷 Ankara, Gazi University Faculty Of Nursing, Turkey