MigraineNCT05454826
Investigation of the Effect of Cold Application in Migraine
A study testing Exercise and Cold Application in people with Migraine and Cold, run by Eylül Pınar KISA at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Migraine, Cold, Relaxation
- What is being tested?
- Exercise and Cold Application
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2022to 30 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- be between 20-45 years old
- Having been diagnosed with migraine at least 6 months ago
- Patient's ability to use a computer
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of the Effect of Cold Application in Addition to Relaxation Exercises in Patients with Migraine
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.
Read more
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.
Read the 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.
- Conditions
- Migraine, Cold, Relaxation, Exercise
- Being tested
- Exercise, Cold Application
- Medical subject headings
- Migraine Disorders, Common Cold, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
Also called Relaxation exercise applications
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).
Cold ApplicationOther
Also called Relaxation exercise+ cold pack applications
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).
| Study group | Role | What they receive |
|---|---|---|
| Cold application group | Experimental | applied relaxation exercise+ cold pack Receives: Other: Cold Application |
| control group | Experimental | applied relaxation exercise Receives: Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 0-6. week
Secondary outcomes (3)
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.
Measured: 0-6. week
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.
Measured: 0-6. week
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.
Measured: 0-6. week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2022
- Study start1 Aug 2022
- Primary completion30 Sep 2022
- Study completion30 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MigraineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eylül Pınar KISA
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Eylül Pınar KISA, Biruni University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05454826
- Sponsor's protocol ID
- migraine
- Status last verified
- Mar 2025
- First submitted
- 7 Jul 2022
- Last updated
- 17 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effect of Cold Application in Addition to Relaxation Exercises in Patients with Migraine
- ClinicalTrials.gov ID
- NCT05454826
- Acronym / sponsor ID
- migraine
- Conditions
- Migraine, Cold, Relaxation, Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Eylül Pınar KISAUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 30 May 2023 (actual)
- First posted
- 12 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cold application group | Experimental | Other: Cold Applicationapplied relaxation exercise+ cold pack |
| control group | Experimental | Other: Exerciseapplied relaxation exercise |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- be between 20-45 years old
- Having been diagnosed with migraine at least 6 months ago
- Patient's ability to use a computer
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExerciseAlso: Relaxation exercise applications1st 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). | Other | control group |
| Cold ApplicationAlso: Relaxation exercise+ cold pack applications1st 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). | Other | Cold application group |
Primary outcome
Migraine Disability Assessment questionnaire
Time frame: 0-6. week
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.
3 secondary outcomes
World Health Organization quality of life scale ('whoqol-bref')
Time frame: 0-6. week
Visual Analog Scale
Time frame: 0-6. week
Patient case form
Time frame: 0-6. week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise and Cold Application in people with Migraine and Cold, run by Eylül Pınar KISA at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Migraine Disability Assessment questionnaire (time frame: 0-6. week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2025.