ReflexologymigraineNCT06828315
the Effect of Reflexology in Migraine Patients
A study testing Reflexology in people with Reflexology and Migraine, run by Muş Alparslan University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this randomised controlled trial was to evaluate the effect of foot reflexology on pain intensity, fatigue and quality of life in migraine patients. The main questions it aims to answer are: Is foot reflexology effective in reducing pain intensity in migraine patients? Is foot reflexology effective in… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Reflexology, Migraine, Pain
- What is being tested?
- Reflexology
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Oct 2024to 10 Feb 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Being between the ages of 18-60 (to conduct the study with adult individuals and to minimise the effect of age-related variables)
- Being diagnosed with migraine
- Having experienced at least 2 migraine attacks in the last 6 months (to ensure a homogenous group among patients with more chronic or episodic migraine)
- Migraine with a severity of 4 or more with VAS (Visual Analogue Scale) (To prevent mild headaches from affecting the study)
- Having experienced at least 2 migraine attacks in the last 6 months (to ensure a homogenous group among patients with more chronic or episodic migraine)
- To participate and continue to work as a volunteer
Who cannot join
- For female participants: Being pregnant or breastfeeding (as hormone changes may change the effect of migraine and reflexology)
- Having another chronic neurological disease (epilepsy, MS, Parkinson's, etc.) (to avoid the effect of symptoms that may be confused with migraine)
- Being treated with another alternative medicine method (acupuncture, biofeedback, etc.) at the same time (to measure the independent effect of reflexology)
- Regular use of Botox, nerve blockade or invasive treatment for migraine in the last 3 months (to reduce the influence of external factors on migraine severity)
- Severe psychiatric disorders (schizophrenia, bipolar disorder, etc.) or a history of severe depression/anxiety (to isolate the effect of stress and psychological factors on reflexology)
- No previous serious side effects or intolerance to reflexology (important for safety)
- Diabetic neuropathy, severe peripheral neuropathy or severe dermatological disorders (infection, open wound, etc.) in the foot area (as it may affect the applicability of reflexology)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Foot Reflexology as an Adjunctive Therapy in Migraine Management: A Randomized Controlled Trial on Pain, Fatigue, and Quality of Life
The aim of this randomised controlled trial was to evaluate the effect of foot reflexology on pain intensity, fatigue and quality of life in migraine patients.
The main questions it aims to answer are:
Read more
Is foot reflexology effective in reducing pain intensity in migraine patients? Is foot reflexology effective in reducing the fatigue level of migraine patients? Is foot reflexology effective in improving the quality of life of migraine patients? Comparison group: The researchers will evaluate the effects of foot reflexology by comparing the group receiving reflexology intervention with the control group receiving only routine treatment.
Participants were selected according to the following criteria:
Intervention group: Individuals diagnosed with migraine will receive foot reflexology twice a week for a total of 10 sessions.
Control group: No additional intervention will be applied to this group, only their routine treatment and medical follow-up will continue.
Both groups will be evaluated at the beginning and at the end of the study with the Patient Information Form, Migraine 24-Hour Quality of Life Scale (QoLQS), Visual Analogue Scale (VAS) and Fatigue Severity Scale (FSS). After the completion of the study, reflexology will be applied to patients in the control group who are willing to receive reflexology.
- Conditions
- Reflexology, Migraine, Pain, Fatigue, Quality of Life
- Being tested
- Reflexology
- Medical subject headings
- Migraine Disorders, Pain, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ReflexologyOther
Reflexology is a practice based on the fact that the organs in the body are connected to the reflex areas in the hands and feet.
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | reflexology was applied to the experimental group Receives: Other: Reflexology |
| control group | No intervention | reflexology was not applied to the control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale (VAS)
Pain intensity was assessed using the Visual Analog Scale (VAS) for Pain. The Visual Analog Scale is a unidimensional measure of perceived pain intensity. It consists of a 10-centimeter horizontal line anchored by two descriptors: "no pain" (0) and "worst imaginable pain" (10). Participants mark a point on the line corresponding to their perceived pain intensity, resulting in a score ranging from 0 to 10. Higher scores indicate greater pain severity and represent a worse outcome. Lower scores indicate less pain and represent a better outcome.
Measured: At the end of the 5-week intervention
Fatigue Severity Scale (FSS)
The Fatigue Severity Scale (FSS) will be used to evaluate changes in participants' fatigue levels. The FSS consists of nine items scored from 1 to 7, with higher scores indicating greater fatigue severity. The total score ranges from a minimum of 9 to a maximum of 63.
Measured: At the end of the 5-week intervention
24-Hour Migraine-Specific Quality of Life Questionnaire (24 h MQoLQ)
24-Hour Migraine-Specific Quality of Life Questionnaire (24 h MQoLQ) will assess changes in migraine-specific quality of life. It includes five subscales: Migraine Symptoms, Emotions and Concerns, Work Functionality, Social Functionality, and Energy/Vitality. Higher scores indicate better quality of life. The total score ranges from a minimum of 15 to a maximum of 105.
Measured: At the end of the 5-week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2025
- Study start10 Oct 2024
- Primary completion15 Nov 2024
- Study completion10 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for ReflexologyStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Muş Alparslan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cihat Demirel, Muş Alparslan University
- Investigators
- Cihat Demirel, Principal investigator, Muş Alparslan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06828315
- Sponsor's protocol ID
- migraine
- Acronym
- migraine
- Status last verified
- Feb 2026
- First submitted
- 7 Feb 2025
- Last updated
- 4 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- 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 4 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Foot Reflexology as an Adjunctive Therapy in Migraine Management: A Randomized Controlled Trial on Pain, Fatigue, and Quality of Life
- ClinicalTrials.gov ID
- NCT06828315
- Acronym / sponsor ID
- migraine / migraine
- Conditions
- Reflexology, Migraine, Pain, Fatigue, Quality of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Muş Alparslan UniversityUniversity, hospital or other
- Study start
- 10 Oct 2024 (actual)
- Primary completion
- 15 Nov 2024 (actual)
- Study completion
- 10 Feb 2025 (actual)
- First posted
- 14 Feb 2025 (actual)
- Results
- Posted 4 Mar 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this randomised controlled trial was to evaluate the effect of foot reflexology on pain intensity, fatigue and quality of life in migraine patients.
The main questions it aims to answer are:
Is foot reflexology effective in reducing pain intensity in migraine patients? Is foot reflexology effective in reducing the fatigue level of migraine patients? Is foot reflexology effective in improving the quality of life of migraine patients? Comparison group: The researchers will evaluate the effects of foot reflexology by comparing the group receiving reflexology intervention with the control group receiving only routine treatment.
Participants were selected according to the following criteria:
Intervention group: Individuals diagnosed with migraine will receive foot reflexology twice a week for a total of 10 sessions.
Control group: No additional intervention will be applied to this group, only their routine treatment and medical follow-up will continue.
Both groups will be evaluated at the beginning and at the end of the study with the Patient Information Form, Migraine 24-Hour Quality of Life Scale (QoLQS), Visual Analogue Scale (VAS) and Fatigue Severity Scale (FSS). After the completion of the study, reflexology will be applied to patients in the control group who are willing to receive reflexology.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Other: Reflexologyreflexology was applied to the experimental group |
| control group | No intervention | –reflexology was not applied to the control group |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Being between the ages of 18-60 (to conduct the study with adult individuals and to minimise the effect of age-related variables)
- Being diagnosed with migraine
- Having experienced at least 2 migraine attacks in the last 6 months (to ensure a homogenous group among patients with more chronic or episodic migraine)
- Migraine with a severity of 4 or more with VAS (Visual Analogue Scale) (To prevent mild headaches from affecting the study)
- Having experienced at least 2 migraine attacks in the last 6 months (to ensure a homogenous group among patients with more chronic or episodic migraine)
Key exclusion criteria (7 listed)
- For female participants: Being pregnant or breastfeeding (as hormone changes may change the effect of migraine and reflexology)
- Having another chronic neurological disease (epilepsy, MS, Parkinson's, etc.) (to avoid the effect of symptoms that may be confused with migraine)
- Being treated with another alternative medicine method (acupuncture, biofeedback, etc.) at the same time (to measure the independent effect of reflexology)
- Regular use of Botox, nerve blockade or invasive treatment for migraine in the last 3 months (to reduce the influence of external factors on migraine severity)
- Severe psychiatric disorders (schizophrenia, bipolar disorder, etc.) or a history of severe depression/anxiety (to isolate the effect of stress and psychological factors on reflexology)
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 |
|---|---|---|
| ReflexologyReflexology is a practice based on the fact that the organs in the body are connected to the reflex areas in the hands and feet. | Other | experimental group |
Primary outcome
Visual Analog Scale (VAS)
Time frame: At the end of the 5-week intervention
Pain intensity was assessed using the Visual Analog Scale (VAS) for Pain. The Visual Analog Scale is a unidimensional measure of perceived pain intensity. It consists of a 10-centimeter horizontal line anchored by two descriptors: "no pain" (0) and "worst imaginable pain" (10). Participants mark a point on the line corresponding to their perceived pain intensity, resulting in a score ranging from 0 to 10. Higher scores indicate greater pain severity and represent a worse outcome. Lower scores indicate less pain and represent a better outcome.
Fatigue Severity Scale (FSS)
Time frame: At the end of the 5-week intervention
The Fatigue Severity Scale (FSS) will be used to evaluate changes in participants' fatigue levels. The FSS consists of nine items scored from 1 to 7, with higher scores indicating greater fatigue severity. The total score ranges from a minimum of 9 to a maximum of 63.
24-Hour Migraine-Specific Quality of Life Questionnaire (24 h MQoLQ)
Time frame: At the end of the 5-week intervention
24-Hour Migraine-Specific Quality of Life Questionnaire (24 h MQoLQ) will assess changes in migraine-specific quality of life. It includes five subscales: Migraine Symptoms, Emotions and Concerns, Work Functionality, Social Functionality, and Energy/Vitality. Higher scores indicate better quality of life. The total score ranges from a minimum of 15 to a maximum of 105.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Reflexology
Not yet recruiting
Pre-Examination Reflexology for Anxiety and Pain During Pelvic Examination
Anxiety
Recruiting
Reflexology Hand Massage After Cesarean Section
Cesarean Section, Anxiety
Not yet recruiting
Foot Reflexology for Anxiety in Women Hospitalized With High-Risk Pregnancy
Anxiety, Pregnancy, High-Risk
Recruiting
Foot Reflexology and Massage in Neonates Receiving Phototherapy
Neonatal Hyperbilirubinemia
Not yet recruiting
THE EFFECT OF A REFLEXOLOGY PROGRAM ON PREMENSTRUAL SYNDROME SYMPTOMS, QUALİTY OF LİFE AND GENERAL COMFORT
Premenstrual Syndrome-PMS
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.
Cihat Demirel principal investigator
Muş Alparslan University
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 in people with Reflexology and Migraine, run by Muş Alparslan 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 6 inclusion and 7 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 4 Mar 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?
Yes. Results are posted in the registry (first posted 4 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 (VAS) (time frame: At the end of the 5-week intervention). The study lists 3 primary outcomes in all. 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 4 Mar 2026.