Effect of Cold Immersion on Patients With Varicose Vein

Varicose Veins of Lower Limb Clinical Trial

Official title:

Effect of Lower Extremities Cold Immersion Applied to Patients With Varicose Veins on Quality of Life, Anxiety and Symptoms

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05930587
• Other study ID #: GaziUNKalkan
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 25, 2023
• Est. completion date: March 30, 2024

Study information

• Verified date: September 2023
• Source: Gazi University
• Contact: Nevra Kalkan, Dr.
• Phone: +903122162681
• Email: nevra.demir[@]gazi.edu.tr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: March 30, 2024
• Est. primary completion date: October 25, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Varicose Veins
• Varicose Veins of Lower Limb

Intervention

Other:
• Cold water immersion
Cold water immersion (15 degree celsius, 20 minutes)

Locations

Country	Name	City	State
Turkey	Nevra Kalkan	Ankara	Gazi University Faculty Of Nursing

Sponsors (1)

Lead Sponsor	Collaborator
Gazi University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	State and Trade Anxiety Inventory (STAI)	The STAI-X is an extensively used self-administered inventory of two sections containing 20 items each, designed to explore anxiety in its temporary condition of "state anxiety" (STAI-S) and the more general and longstanding quality of "trait anxiety" (STAI-T). The STAI-S assesses how respondents feel "right now, at this moment", and the STAI-T targets how respondents "generally feel". Each item is scored on a 4-point Likert scale, with choices ranging from 1 ("not at all") to 4 ("very much so") for the state scale, and 1 ("almost never") to 4 ("almost always") for the trait scale. The minimum score for each section is 20, with a maximum score of 80. A total score of 40 or more indicates an anxious condition. The higher the score is, the more severe the anxiety condition.	four weeks
Primary	The Patient Questionnaire	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).	four weeks
Secondary	VEINES-QOL/Sym	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.	four weeks

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