Effect of Cold Immersion on Patients With Varicose Vein

NCT ID: NCT05930587

Last Updated: 2023-09-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-25

Study Completion Date

2024-03-30

Brief Summary

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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

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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

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Varicose Veins of Lower Limb

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

2 groups (experimental group and control group)
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Investigators Outcome Assessors
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.

Study Groups

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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.

Group Type EXPERIMENTAL

Cold water immersion

Intervention Type OTHER

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Cold water immersion

Cold water immersion (15 degree celsius, 20 minutes)

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Gazi University

OTHER

Sponsor Role lead

Responsible Party

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Nevra KALKAN

Res. Asst. PhD NEVRA KALKAN, Faculty of Nursing, Department of Surgical Nursing

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Nevra Kalkan

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

Site Status

Countries

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Turkey (Türkiye)

Central Contacts

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Nevra Kalkan, Dr.

Role: CONTACT

+903122162681

Facility Contacts

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Nevra Kalkan, Dr.

Role: primary

+903122162681

Related Links

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Other Identifiers

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GaziUNKalkan

Identifier Type: -

Identifier Source: org_study_id

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