- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05930587
Effect of Cold Immersion on Patients With Varicose Vein
Effect of Lower Extremities Cold Immersion Applied to Patients With Varicose Veins on Quality of Life, Anxiety and Symptoms
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Nevra Kalkan, Dr.
- Phone Number: +903122162681
- Email: nevra.demir@gazi.edu.tr
Study Locations
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Gazi University Faculty Of Nursing
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Ankara, Gazi University Faculty Of Nursing, Turkey, 06490
- Nevra Kalkan
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Contact:
- Nevra Kalkan, Dr.
- Phone Number: +903122162681
- Email: nevra.demir@gazi.edu.tr
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control
No intervention will be made to the control group, only the data will be collected at the same time as the study group.
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Experimental: 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. |
Cold water immersion (15 degree celsius, 20 minutes)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The Patient Questionnaire
Time Frame: four weeks
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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).
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four weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
VEINES-QOL/Sym
Time Frame: 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.
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four weeks
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
State and Trade Anxiety Inventory (STAI)
Time Frame: four weeks
|
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.
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four weeks
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Collaborators and Investigators
Sponsor
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GaziUNKalkan
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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