Effect of Cold Immersion on Patients With Varicose Vein

NCT05930587 | Unknown

• 1 other identifier: GaziUNKalkan
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Varicose Veins of Lower Limb

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• VEINES-QOL/Sym

  four weeks

Other Outcomes (1)

• State and Trade Anxiety Inventory (STAI)

  four weeks

Study Arms (2)

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.

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.

Interventions

Cold water immersion OTHER

Cold water immersion (15 degree celsius, 20 minutes)

Cold water immersion

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Gazi University: lead

Study Sites (1)

Nevra Kalkan

Ankara, Gazi University Faculty of Nursing, 06490, Turkey (Türkiye)

Location

Related Links

• Related Info

Central Study Contacts

Nevra Kalkan, Dr.

CONTACT

+903122162681; nevra.demir@gazi.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The patients in the experimental and control groups in the study will be assigned to the groups by a statistician using a computer program, and the list of patients in the experimental and control groups will be submitted to the head nurse of the cardiovascular surgery clinic.Researchers will not be informed about which group the patients are in. 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Res. Asst. PhD NEVRA KALKAN, Faculty of Nursing, Department of Surgical Nursing

Model Details: 2 groups (experimental group and control group)

Study Record Dates

• First Submitted: June 13, 2023
• First Posted: July 5, 2023
• Study Start: September 25, 2023
• Primary Completion: October 25, 2023
• Study Completion: March 30, 2024
• Last Updated: September 25, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)