Varicose Veins of Lower LimbNCT05930587
Effect of Cold Immersion on Patients With Varicose Vein
A study testing Cold water immersion in people with Varicose Veins of Lower Limb, run by Gazi University at 1 site in Turkey (Türkiye).
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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Varicose Veins of Lower Limb
- What is being tested?
- Cold water immersion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Sep 2023to 30 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Nevra Kalkan
Ankara, Gazi University Faculty of Nursing, 06490
Nevra Kalkan, Dr., +903122162681, nevra.demir@gazi.edu.tr
About this study
Official title: 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.
Read the 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.
- Conditions
- Varicose Veins of Lower Limb
- Being tested
- Cold water immersion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cold water immersionOther
Cold water immersion (15 degree celsius, 20 minutes)
| Study group | Role | What they receive |
|---|---|---|
| Cold water immersion | Experimental | 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. Receives: Other: Cold water immersion |
| Control | No intervention | No intervention will be made to the control group, only the data will be collected at the same time as the study group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: four weeks
Secondary outcomes (1)
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.
Measured: four weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2023
- Study start25 Sep 2023 (estimated)
- Primary completion25 Oct 2023 (estimated)
- Study completion30 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Varicose Veins of Lower LimbStudies of the same condition, open and under way.
- More trials run by Gazi UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 2 groups (experimental group and control group)
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nevra KALKAN, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05930587
- Sponsor's protocol ID
- GaziUNKalkan
- Status last verified
- Sep 2023
- First submitted
- 13 Jun 2023
- Last updated
- 25 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no a plan to make individual participant data (IPD) available to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Lower Extremities Cold Immersion Applied to Patients With Varicose Veins on Quality of Life, Anxiety and Symptoms
- ClinicalTrials.gov ID
- NCT05930587
- Acronym / sponsor ID
- GaziUNKalkan
- Conditions
- Varicose Veins of Lower Limb
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 25 Sep 2023 (estimated)
- Primary completion
- 25 Oct 2023 (estimated)
- Study completion
- 30 Mar 2024 (estimated)
- First posted
- 5 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 2 groups (experimental group and control group)
| Arm | Type | Receives |
|---|---|---|
| Cold water immersion | Experimental | Other: Cold water immersionThe 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. |
| Control | No intervention | –No intervention will be made to the control group, only the data will be collected at the same time as the study group. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cold water immersionCold water immersion (15 degree celsius, 20 minutes) | Other | Cold water immersion |
Primary outcome
The Patient Questionnaire
Time frame: 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).
1 secondary outcome
VEINES-QOL/Sym
Time frame: four weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2023.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No. There is no a plan to make individual participant data (IPD) available to other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cold water immersion in people with Varicose Veins of Lower Limb, run by Gazi University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nevra Kalkan, Dr. (+903122162681, nevra.demir@gazi.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Patient Questionnaire (time frame: four weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2023.