Migraine DiseaseNCT07028684
Effects of Foot Reflexology Massage in Migraine
A study testing Reflexology Massage in people with Migraine Disease, run by Karabuk University at 1 site in Turkey (Türkiye).
Trial summary
Migraine is a primary headache type that usually manifests itself with unilateral, moderate to severe throbbing headaches, often accompanied by symptoms such as nausea, vomiting, and sensitivity to light and sound. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Migraine Disease
- What is being tested?
- Reflexology Massage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2025to 15 Mar 2026
- 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 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Being between the ages of 18-45
- Being diagnosed with migraine by a neurologist according to the International Headache Society (IHS) criteria
- Volunteering to participate in the study
- Being able to read and write
- Not having entered menopause
Who cannot join
- Any neurological or musculoskeletal disease other than migraine
- History of cervical or cranial surgery
- Irritation or ulceration on the skin area to be reflexologized
- Receiving non-drug migraine treatment (acupuncture, dry needle, etc.)
- Those who have received physiotherapy at least 6 months ago
- Presence of diabetic foot
- Open wounds on the foot
- Pregnant individuals or individuals who become pregnant during the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Foot Reflexology Massage in Pain, Sleep and Quality of Life in Females With Migraine
Migraine is a primary headache type that usually manifests itself with unilateral, moderate to severe throbbing headaches, often accompanied by symptoms such as nausea, vomiting, and sensitivity to light and sound. The prevalence and impact of headaches are more pronounced, especially among women, and this condition is among the top five causes of disability in women. Reflexology, one of the complementary treatment methods, is an alternative medical practice that produces beneficial effects on the human body by applying pressure to specific points or areas called "reflex areas" on the feet, hands, and ears.The aim of this randomized controlled trial was to evaluate the effects of foot reflexology massage on pain, sleep, and quality of life in women with migraine. All patients included in this study will be evaluated with the following tests and scales three times: before, after, and 2 weeks after the end of the 5-week (10 sessions in total) treatment. After the initial evaluations of the study, migraine patients will be divided into 2 groups using a simple random sampling method in the computer randomization program. The first group will receive a foot reflexology massage. The second group will be the control group.
Read the detailed description
Migraine is a primary headache type that usually manifests itself with unilateral, moderate to severe throbbing headaches, often accompanied by symptoms such as nausea, vomiting, and sensitivity to light and sound. The prevalence and impact of headaches are more pronounced, especially among women, and this condition is among the top five causes of disability in women. Reflexology, one of the complementary treatment methods, is an alternative medical practice that produces beneficial effects on the human body by applying pressure to specific points or areas called "reflex areas" on the feet, hands, and ears. Reflexology can be used as a complementary or supportive method of treatment because it is a massage form that regulates complex body functions and has relaxing and loosening effects. In studies; It has been found that foot reflexology reduces patients' pain and improves their sleep quality. The aim of this randomized controlled trial was to evaluate the effects of foot reflexology massage on pain, sleep, and quality of life in women with migraine. All patients included in this study will be evaluated with the following tests and scales three times: before, after, and 2 weeks after the end of the 5-week (10 sessions in total) treatment. After the initial evaluations of the study, migraine patients will be divided into 2 groups using a simple random sampling method in the computer randomization program. The first group will receive a foot reflexology massage. The second group will be the control group.
- Conditions
- Migraine Disease
- Being tested
- Reflexology Massage
- Keywords
- Migraine, Massage, Headache
- Medical subject headings
- Migraine Disorders, Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reflexology MassageOther
Reflexology massage will be applied twice a week for 30 minutes per session, for a total of 10 sessions. The treatment will begin by relaxing the ankle with a few passive movements. Reflexology massage will be applied to the right foot first and then to the left foot.
Target Areas to be Applied to the Right Foot: Brain, Pineal, Hypophysis, Hypothalamus and Thalamus, Temples, Eye area and Optic nerve, Ear area, Middle ear and Balance point, Neck.
Other areas to be applied to the right foot: Thyroid and Parathyroid, Lung, Liver, Face area, Speech center and Thymus, Teeth, Diaphragm, Vertebra, Extremities.
Areas to be applied to the left foot: Kidney, Diaphragm, Intestines, Neck, Vertebra, Extremities.
The session is completed from the left foot by applying to the lymph inlet, lymph channel and diaphragm from both feet.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | No treatment other than medication will be given for migraine. |
| Experimental | Experimental | Reflexology massage will be applied twice a week for 30 minutes per session, for a total of 10 sessions. Receives: Other: Reflexology Massage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale
Pain intensity will be assessed with a visual analog scale. The patient marks his/her own pain on a 10 (represents "worst pain imaginable") cm ruler with painlessness 0 (represents "no pain") at one end and the most severe pain possible at the other end.
Measured: 5 weeks
Secondary outcomes (4)
Headache Impact Test
It will be used to measure the impact of headache on participants' quality of life. Items in this test assess areas such as vitality, pain and psychological distress, as well as sociability, role and cognitive functioning. Each item is answered on a 5-point Likert scale. The final score is determined by summing the scores on the six items, ranging from 36 to 78 points, with a higher score indicating a greater effect.
Measured: Five weeks
Pittsburgh Sleep Quality Index
Sleep quality will be assessed with a scale consisting of 24 questions and 7 categories. Each item is evaluated with a score between 0 and 3, with 0 being no problems and 3 being serious problems. The total score is between 0-21. A high total score indicates poor sleep quality.
Measured: Five weeks
Migraine disability assessment
It is a questionnaire that has proven to be reliable and valid in determining the degree of disability caused by migraine. MIDAS assesses the degree of disability from 1 to 4 based on the number of days (score). Grade I: Little or no disability (0-5 days), Grade II: Mild disability (6-10 days), Grade III: Moderate disability (11-20 days) and Grade IV (21+ days): Indicates severe disability.
Measured: Five weeks
24-h Migraine Quality of Life Questionnaire
The 24-hour quality of life scale will be used to evaluate the changes in the quality of life of the patients within 24 hours after the first dose of migraine medication. The scale has 3 sections and a total of 15 items covering quality of life areas under the headings of Migraine symptoms, Emotions, Worries, Work Functionality, Social Functionality, Energy-Vitality. The total score is minimum 15 and maximum 105. The higher the scores the individual receives from the scale, the higher the quality of life of the individual, and the lower the score, the lower the quality of life.
Measured: Five weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2025
- Study start1 Jun 2025
- Primary completion15 Dec 2025
- Study completion15 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Migraine DiseaseStudies 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
- Model description
- The study includes two groups with massage and control group.
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karabuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tarik Ozmen, Karabuk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07028684
- Sponsor's protocol ID
- KBU-FTR-2025-2178
- Status last verified
- Apr 2026
- First submitted
- 11 Jun 2025
- Last updated
- 15 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Foot Reflexology Massage in Pain, Sleep and Quality of Life in Females With Migraine
- ClinicalTrials.gov ID
- NCT07028684
- Acronym / sponsor ID
- KBU-FTR-2025-2178
- Conditions
- Migraine Disease
- Keywords
- Migraine, Massage, Headache
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Karabuk UniversityUniversity, hospital or other
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 15 Dec 2025 (actual)
- Study completion
- 15 Mar 2026 (actual)
- First posted
- 19 Jun 2025 (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 primary headache type that usually manifests itself with unilateral, moderate to severe throbbing headaches, often accompanied by symptoms such as nausea, vomiting, and sensitivity to light and sound. The prevalence and impact of headaches are more pronounced, especially among women, and this condition is among the top five causes of disability in women. Reflexology, one of the complementary treatment methods, is an alternative medical practice that produces beneficial effects on the human body by applying pressure to specific points or areas called "reflex areas" on the feet, hands, and ears.The aim of this randomized controlled trial was to evaluate the effects of foot reflexology massage on pain, sleep, and quality of life in women with migraine. All patients included in this study will be evaluated with the following tests and scales three times: before, after, and 2 weeks after the end of the 5-week (10 sessions in total) treatment. After the initial evaluations of the study, migraine patients will be divided into 2 groups using a simple random sampling method in the computer randomization program. The first group will receive a foot reflexology massage. The second group will be the control group.
Detailed description
Migraine is a primary headache type that usually manifests itself with unilateral, moderate to severe throbbing headaches, often accompanied by symptoms such as nausea, vomiting, and sensitivity to light and sound. The prevalence and impact of headaches are more pronounced, especially among women, and this condition is among the top five causes of disability in women. Reflexology, one of the complementary treatment methods, is an alternative medical practice that produces beneficial effects on the human body by applying pressure to specific points or areas called "reflex areas" on the feet, hands, and ears. Reflexology can be used as a complementary or supportive method of treatment because it is a massage form that regulates complex body functions and has relaxing and loosening effects. In studies; It has been found that foot reflexology reduces patients' pain and improves their sleep quality. The aim of this randomized controlled trial was to evaluate the effects of foot reflexology massage on pain, sleep, and quality of life in women with migraine. All patients included in this study will be evaluated with the following tests and scales three times: before, after, and 2 weeks after the end of the 5-week (10 sessions in total) treatment. After the initial evaluations of the study, migraine patients will be divided into 2 groups using a simple random sampling method in the computer randomization program. The first group will receive a foot reflexology massage. The second group will be the control group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study includes two groups with massage and control group.
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –No treatment other than medication will be given for migraine. |
| Experimental | Experimental | Other: Reflexology MassageReflexology massage will be applied twice a week for 30 minutes per session, for a total of 10 sessions. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Being between the ages of 18-45
- Being diagnosed with migraine by a neurologist according to the International Headache Society (IHS) criteria
- Volunteering to participate in the study
- Being able to read and write
- Not having entered menopause
Key exclusion criteria (8 listed)
- Any neurological or musculoskeletal disease other than migraine
- History of cervical or cranial surgery
- Irritation or ulceration on the skin area to be reflexologized
- Receiving non-drug migraine treatment (acupuncture, dry needle, etc.)
- Those who have received physiotherapy at least 6 months ago
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 |
|---|---|---|
| Reflexology MassageReflexology massage will be applied twice a week for 30 minutes per session, for a total of 10 sessions. The treatment will begin by relaxing the ankle with a few passive movements. Reflexology massage will be applied to the right foot first and then to the left foot. Target Areas to be Applied to the Right Foot: Brain, Pineal, Hypophysis, Hypothalamus and Thalamus, Temples, Eye area and Optic nerve, Ear area, Middle ear and Balance point, Neck. Other areas to be applied to the right foot: Thyroid and Parathyroid, Lung, Liver, Face area, Speech center and Thymus, Teeth, Diaphragm, Vertebra, Extremities. Areas to be applied to the left foot: Kidney, Diaphragm, Intestines, Neck, Vertebra, Extremities. The session is completed from the left foot by applying to the lymph inlet, lymph channel and diaphragm from both feet. | Other | Experimental |
Primary outcome
Visual Analog Scale
Time frame: 5 weeks
Pain intensity will be assessed with a visual analog scale. The patient marks his/her own pain on a 10 (represents "worst pain imaginable") cm ruler with painlessness 0 (represents "no pain") at one end and the most severe pain possible at the other end.
4 secondary outcomes
Headache Impact Test
Time frame: Five weeks
Pittsburgh Sleep Quality Index
Time frame: Five weeks
Migraine disability assessment
Time frame: Five weeks
24-h Migraine Quality of Life Questionnaire
Time frame: Five weeks
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 15 Apr 2026.
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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 Reflexology Massage in people with Migraine Disease, run by Karabuk University 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 5 inclusion and 8 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 15 Apr 2026. 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?
Visual Analog Scale (time frame: 5 weeks). 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 15 Apr 2026.