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Investigation of the Effect of Cold Application in Migraine

Primary Purpose

Migraine, Cold, Relaxation

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Exercise
Cold Application
Sponsored by
Eylül Pınar KISA
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Migraine

Eligibility Criteria

20 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • be between 20-45 years old
  • Having been diagnosed with migraine at least 6 months ago
  • Patient's ability to use a computer

Exclusion Criteria:

  • Being in the period of menstruation
  • Sensitivity to cold (those who have 5 or more sensitivity on a 10 cm scale)
  • Having any neurological or orthopedical problems
  • Using antidepressants etc.
  • Poor mental state

Sites / Locations

  • Eylül Pınar KısaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Cold application group

control group

Arm Description

applied relaxation exercise+ cold pack

applied relaxation exercise

Outcomes

Primary Outcome Measures

Migraine Disability Assessment questionnaire
The Migraine Disability Assessment questionnaire (MIDAS) questionnaire was developed to measure the effect of headaches on a person's daily functioning. MIDAS takes into account the last three months and consists of five questions. It is a simple and short survey. These questions are used to determine your score and are then matched to a disability level. As the score increases, the severity of migraine pain increases.

Secondary Outcome Measures

World Health Organization quality of life scale ('whoqol-bref')
The scale measures physical, mental, social and environmental well-being and consists of 26 questions. The scale was used in patients with migraine. Since each domain independently expresses the quality of life in its own field, field scores are calculated between 4-20. The higher the score, the higher the quality of life.
Visual Analog Scale
Patients will be asked to mark the degree of pain they feel during the attack period and during the attack-free period on the 10 cm VAS line. "If you wanted to rate your headache, how many points would you give it? 10 if you have very severe pain; If you have no pain, mark 0 points." The marked point will be measured and recorded with a tape measure.
Patient case form
It consists of questions of age, gender, height, weight and body mass index, educational status, alcohol/cigarette use, history of other diseases, family history of migraine, history of accident and trauma, medications used, number of attacks in the last 1 month, and duration of attacks. . In this form, the person's sensitivity to cold will also be questioned.

Full Information

First Posted
July 7, 2022
Last Updated
July 19, 2022
Sponsor
Eylül Pınar KISA
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1. Study Identification

Unique Protocol Identification Number
NCT05454826
Brief Title
Investigation of the Effect of Cold Application in Migraine
Official Title
Investigation of the Effect of Cold Application in Addition to Relaxation Exercises in Patients With Migraine
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2022 (Actual)
Primary Completion Date
August 15, 2022 (Anticipated)
Study Completion Date
August 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Eylül Pınar KISA

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
Migraine is a headache that is paroxysmal and can last for hours, sometimes even days due to untreated or ineffective treatment is usually unilateral, throbbing, severe enough to prevent the person's daily life activities, and increases with head movements. It is a chronic disorder characterized by recurrent moderate and severe headaches, mostly associated with a few symptoms in the autonomic nervous system. Migraine consists of recurrent headache attacks accompanied by neurological, gastrointestinal, and autonomic symptoms. Migraine is the most common chronic headache in epidemiological studies. Studies have shown that migraine affects 12% of the general population. The aim of migraine treatment is to reduce the frequency, duration, and severity of migraine attacks, to reduce the losses caused by migraine, and increase the quality of life. In the treatment of migraine, non-pharmacological treatment is as important as pharmacological treatment. Some individuals prefer drug-free treatment methods because of the side effects drugs. In recent years, as the mechanisms of headaches have been better understood, significant developments have been made in treatment methods. Different physiotherapy and rehabilitation methods have been used for treatment. There are studies in which cold application is used in migraine patients, but a study evaluating the effectiveness of cold application has not been found in the literature. The systemic effects of cold have two main purposes: to maintain the current body temperature and to produce energy to raise the fallen body temperature. Knowing both the local and systemic effects of cold guides its use in treatment. The aim of this study was to diagnose migraine. To investigate the effectiveness of cold application applied in addition to relaxation exercises in individuals.
Detailed Description
Thirty migraine patients diagnosed by a physician will be included in our study. Participants will be divided into two groups as randomized controlled. Only relaxation exercises will be applied to a group for 6 weeks, 3 days a week. In the other group, relaxation In addition to the exercises, cold will be applied. The sociodemographic information of the patients will be evaluated with the "patient case form", the pain severity will be evaluated with the "visual analog scale" and the quality of life will be evaluated with the world health organization quality of life scale ('whoqol-bref'). Migraine disability rating scale (MIDAS) will be used for functionality. Statistical analysis of data SPSS It will be done using the 24.0 (Statistical Package for Social Sciences) program and p≤0.05 will be considered statistically significant in all analyzes. The reason why the investigators chose cold application in addition to relaxation exercises in our study is that it is a low-cost, risk-free method that everyone can access. It is also an easy-to-apply method.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine, Cold, Relaxation, Exercise

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cold application group
Arm Type
Experimental
Arm Description
applied relaxation exercise+ cold pack
Arm Title
control group
Arm Type
Experimental
Arm Description
applied relaxation exercise
Intervention Type
Other
Intervention Name(s)
Exercise
Other Intervention Name(s)
Relaxation exercise applications
Intervention Description
1st group (n=15) relaxation exercises, 2nd group (n=15) relaxation exercises+cold compression. The exercise program will be applied for 6 weeks, 3 days a week * 45 minutes. Relaxation exercises will be applied to the patients 3 days a week using web-based methods (Zoom).
Intervention Type
Other
Intervention Name(s)
Cold Application
Other Intervention Name(s)
Relaxation exercise+ cold pack applications
Intervention Description
1st group (n=15) relaxation exercises, 2nd group (n=15) relaxation exercises+cold compression. The exercise program will be applied for 6 weeks, 3 days a week * 45 minutes. Relaxation exercises will be applied to the patients 3 days a week using web-based methods (Zoom).
Primary Outcome Measure Information:
Title
Migraine Disability Assessment questionnaire
Description
The Migraine Disability Assessment questionnaire (MIDAS) questionnaire was developed to measure the effect of headaches on a person's daily functioning. MIDAS takes into account the last three months and consists of five questions. It is a simple and short survey. These questions are used to determine your score and are then matched to a disability level. As the score increases, the severity of migraine pain increases.
Time Frame
0-6. week
Secondary Outcome Measure Information:
Title
World Health Organization quality of life scale ('whoqol-bref')
Description
The scale measures physical, mental, social and environmental well-being and consists of 26 questions. The scale was used in patients with migraine. Since each domain independently expresses the quality of life in its own field, field scores are calculated between 4-20. The higher the score, the higher the quality of life.
Time Frame
0-6. week
Title
Visual Analog Scale
Description
Patients will be asked to mark the degree of pain they feel during the attack period and during the attack-free period on the 10 cm VAS line. "If you wanted to rate your headache, how many points would you give it? 10 if you have very severe pain; If you have no pain, mark 0 points." The marked point will be measured and recorded with a tape measure.
Time Frame
0-6. week
Title
Patient case form
Description
It consists of questions of age, gender, height, weight and body mass index, educational status, alcohol/cigarette use, history of other diseases, family history of migraine, history of accident and trauma, medications used, number of attacks in the last 1 month, and duration of attacks. . In this form, the person's sensitivity to cold will also be questioned.
Time Frame
0-6. week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: be between 20-45 years old Having been diagnosed with migraine at least 6 months ago Patient's ability to use a computer Exclusion Criteria: Being in the period of menstruation Sensitivity to cold (those who have 5 or more sensitivity on a 10 cm scale) Having any neurological or orthopedical problems Using antidepressants etc. Poor mental state
Facility Information:
Facility Name
Eylül Pınar Kısa
City
İ̇stanbul
ZIP/Postal Code
34720
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
eylül pınar kısa
Phone
05321307023
Email
ekisa@biruni.edu.tr

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Investigation of the Effect of Cold Application in Migraine

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