Effect of Cold Immersion on Patients With Varicose Vein
NCT ID: NCT05930587
Last Updated: 2023-09-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
60 participants
INTERVENTIONAL
2023-09-25
2024-03-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Effect of Cold Pressure in the Prevention of Hematoma and Ecchymosis
NCT05553821
Effect of Pressure on Skin Temperature When Using a Cryocompression Device
NCT05454982
The Effect of Warmed Socks Developed as Wearable Technology on Hypothermia, Thermal Comfort Perception and Shivering
NCT06283771
Cold Water Immersion and Atherosclerosis, Inflammation, Fat Accumulation and Lipid Profile Parameters
NCT04642066
Mitigating Heat-induced Physiological Strain and Discomfort in Older Adults Via Lower Limb Immersion and Neck Cooling
NCT05601713
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
DOUBLE
In the research, the application of cold immersion to the patients in the experimental group will be explained by the nurse in charge, and data collection forms will be applied to both the experimental and control groups by the head nurse.
As the patients will do the application directly themselves, blinding will not be possible.
In addition, codes in the form of x and y will be given to the experimental and control groups and support will be received from another statistical expert.
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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
Cold water immersion (15 degree celsius, 20 minutes)
Control
No intervention will be made to the control group, only the data will be collected at the same time as the study group.
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Cold water immersion
Cold water immersion (15 degree celsius, 20 minutes)
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* Patient having surgery during the study
* The patient's desire to withdraw from the study
18 Years
65 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Gazi University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Nevra KALKAN
Res. Asst. PhD NEVRA KALKAN, Faculty of Nursing, Department of Surgical Nursing
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Nevra Kalkan
Ankara, Gazi University Faculty of Nursing, Turkey (Türkiye)
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Related Links
Access external resources that provide additional context or updates about the study.
Related Info
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
GaziUNKalkan
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.