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Effect of Cold Immersion on Patients With Varicose Vein

Primary Purpose

Varicose Veins of Lower Limb

Status
Not yet recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Cold water immersion
Sponsored by
Gazi University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Varicose Veins of Lower Limb

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Nevra Kalkan

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Cold water immersion

Control

Arm 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 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.

No intervention will be made to the control group, only the data will be collected at the same time as the study group.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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.

Full Information

First Posted
June 13, 2023
Last Updated
September 22, 2023
Sponsor
Gazi University
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1. Study Identification

Unique Protocol Identification Number
NCT05930587
Brief Title
Effect of Cold Immersion on Patients With Varicose Vein
Official Title
Effect of Lower Extremities Cold Immersion Applied to Patients With Varicose Veins on Quality of Life, Anxiety and Symptoms
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 25, 2023 (Anticipated)
Primary Completion Date
October 25, 2023 (Anticipated)
Study Completion Date
March 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Gazi University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Varicose Veins of Lower Limb

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
2 groups (experimental group and control group)
Masking
InvestigatorOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cold water immersion
Arm Type
Experimental
Arm 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 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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
No intervention will be made to the control group, only the data will be collected at the same time as the study group.
Intervention Type
Other
Intervention Name(s)
Cold water immersion
Intervention Description
Cold water immersion (15 degree celsius, 20 minutes)
Primary Outcome Measure Information:
Title
The Patient Questionnaire
Description
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).
Time Frame
four weeks
Secondary Outcome Measure Information:
Title
VEINES-QOL/Sym
Description
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.
Time Frame
four weeks
Other Pre-specified Outcome Measures:
Title
State and Trade Anxiety Inventory (STAI)
Description
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.
Time Frame
four weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nevra Kalkan, Dr.
Phone
+903122162681
Email
nevra.demir@gazi.edu.tr
Facility Information:
Facility Name
Nevra Kalkan
City
Ankara
State/Province
Gazi University Faculty Of Nursing
ZIP/Postal Code
06490
Country
Turkey
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nevra Kalkan, Dr.
Phone
+903122162681
Email
nevra.demir@gazi.edu.tr

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There is no a plan to make individual participant data (IPD) available to other researchers.
Links:
URL
https://orcid.org/0000-0003-4536-7933
Description
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Effect of Cold Immersion on Patients With Varicose Vein

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