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The Effect of Foot Reflexology in Women With Migraine

9 września 2026 zaktualizowane przez: Nurcan Contarli, Karabuk University

The Effect of Foot Reflexology on Pain, Disability, Anxiety, Kinesiophobia, and Postural Control in Women With Migraine

This prospective randomized controlled study aims to investigate the effects of foot massage on pain, anxiety, kinesiophobia, and postural control in women aged 18-45 years diagnosed with migraine who attend the Neurology Outpatient Clinic of Karabük University Karabük Training and Research Hospital. Participants who meet the inclusion and exclusion criteria will be randomly allocated into either a foot massage group or a control group using a simple randomization method. The foot massage group will receive a total of 10 sessions of foot massage over 5 weeks, with two sessions per week, while no massage intervention will be applied to the control group. All participants will be assessed at baseline, immediately after the intervention period, and two weeks following the completion of treatment. The findings of this study are expected to provide evidence regarding the effectiveness of foot massage in the management of symptoms in women with migraine.

Przegląd badań

Status

Zakończony

Warunki

Interwencja / Leczenie

Szczegółowy opis

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 3 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. The third group will be the sham group.

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

36

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

  • Turcja (Türkiye)
    • Karabük Province
      • Karabük, Karabük Province, Turcja (Türkiye), 78050
        • Karabuk University

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły

Akceptuje zdrowych ochotników

Tak

Opis

Inclusion Criteria:

  • Being a woman between the ages of 18 and 47
  • Having been diagnosed with migraine by a neurologist according to the International Headache Society (IHS) criteria
  • Volunteering to participate in the study
  • Being literate
  • Not having entered menopause

Exclusion Criteria:

  • Having any neurological disease other than migraine
  • Having a psychiatric illness
  • Smoking
  • Having a musculoskeletal disease affecting the head and neck area
  • Having a history of cervical or cranial surgery
  • Having irritation or ulceration in the skin area to be massaged
  • Receiving migraine treatment other than pharmacological treatment (acupuncture, dry needling, cupping, etc.)
  • Having diabetic foot
  • Having open wounds on the foot
  • Pregnant individuals or individuals who become pregnant during the study period

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Brak interwencji: control group
The control group will not receive any foot reflexology therapy or other treatment intervention.
Eksperymentalny: Migraine group
Before starting foot reflexology treatment, patients will be informed about the treatment process. The treatment will be performed by a physiotherapist twice a week, with each session lasting 30 minutes, for a total of 10 sessions.
Procedura: foot reflexology

Before the treatment program begins, participants will be informed about the treatment procedure. The intervention will be administered by a physiotherapist certified as a Reflexology Practitioner, who has received formal training in reflexology. The treatment will consist of 10 sessions delivered over 5 weeks, with two 30-minute sessions per week.

Each session will begin with several passive ankle movements to promote relaxation of the foot and ankle region. Reflexology treatment will be applied first to the right foot and then to the left foot.

Target areas on the right foot: Brain, pineal gland, pituitary gland, hypothalamus and thalamus, temples, eye region and optic nerve, ear region, middle ear and balance point, and neck.

Additional areas treated on the right foot: Thyroid and parathyroid glands, lungs, liver, facial region, speech center, thymus gland, teeth, diaphragm, vertebral column, and extremities.

Areas treated on the left foot: Kidneys, diaphragm, intestines, n
Pozorny komparator: Sham group
superficial massage group
Inny: Sham massage
The sham group received a superficial massage on the soles of the feet, avoiding targeting reflexology points.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Headache Impact Test (HIT-6)
Ramy czasowe: 2 days
The Headache Impact Test (HIT-6) is a self-report questionnaire designed to assess the impact of headache on quality of life. In 2021, Dikmen et al. conducted a study on the reliability and validity of the Turkish version of the Headache Impact Test (HIT-6) in migraine patients. The test items assess areas such as vitality, pain, and psychological distress, as well as sociability, role, and cognitive functioning. Three of the six items specifically address the previous four weeks, while the remaining three items do not have a defined time frame. Each item is answered using a 5-point Likert scale (6=never, 8=rarely, 10=sometimes, 11=very often, 13=always). The final score is calculated by summing the scores from all six items, ranging from 36 to 78 points. Impact is categorized on a scale of ≤49 points (very little or no impact), 50-55 points (some impact), 56-59 points (significant impact), and ≥60 points (strong impact), with higher scores indicating a greater impact.
2 days
Migraine Disability Assessment Scale
Ramy czasowe: 2 days
The Migraine Disability Assessment Scale was used to measure the impact of migraine on a patient's life. This scale, consisting of 5 questions and 4 disability levels from I to IV (no or little disability, moderate, severe disability), was completed by patients during assessments one week before the injection, and during assessments 4 weeks (+7 days) and 12 weeks (+7 days) after the injection. Patients were asked questions about their work/school activities. The total score ranged from 0 to 27. Scores of 0-5 were classified as Level I, 6-10 as Level II, 11-20 as Level III, and scores above 21 as Level IV.
2 days
International Physical Activity Questionnaire-Short Form
Ramy czasowe: 2 days
The International Physical Activity Questionnaire - Short Form is a reliable and valid self-report questionnaire developed to assess individuals' levels of physical activity. Recommended by the World Health Organization, this tool is widely used, particularly in epidemiological studies. The seven-question questionnaire provides information on time spent walking, moderate-to-vigorous, and vigorous activities. Time spent sitting is assessed as a separate question. Scoring involves summing the duration (minutes) and frequency (days) of walking, moderate-to-vigorous activity, and vigorous activity. A score of "MET-minutes" is obtained from these calculations. One MET-minute is calculated by multiplying the number of minutes spent on the activity by the MET score.
2 days
Beck Anxiety Scale
Ramy czasowe: 2 days
The Beck Anxiety Scale (BAS) was developed to measure characteristic anxiety and worry symptoms in patients. This 21-item scale, with scores ranging from 0 to 63 (higher scores indicating severe anxiety), was completed by patients during assessments one week before the injection, and again four weeks (+7 days) and twelve weeks (+7 days) after the injection. The control group completed the scale once. For each item, patients selected one of the following options: 0 = none, 1 = mild, 2 = moderate, and 3 = severe, resulting in a total score ranging from 0 to 63. Scores of 0-7 were considered normal, 8-15 mild, 16-25 moderate, and 26-63 severe.
2 days
Assessment of postural control
Ramy czasowe: 2 days
Postural balance will be assessed using a device that measures body sway by sensing foot pressure. The platform on the device detects body sways. The platform consists of a hard surface, but a soft surface can be achieved by placing a foam cushion on it. The platform must be placed on a flat surface so that it does not move. Through the platform, the individual's center of pressure is visualized, and oscillations occurring in the anteroposterior (AP) and mediolateral (ML) directions can be monitored. Changes occurring on the platform are displayed on a computer screen using Bertec Workbook software.
2 days
Tampa Kinesiophobia Scale
Ramy czasowe: 2 days
The Tampa Kinesiophobia Scale (TMS) is a self-report scale developed to assess individuals' levels of avoidance of movement due to fear of pain or re-injury. Kinesiophobia is a significant psychological factor, particularly prevalent in individuals with chronic pain, and can lead to functional limitations by restricting participation in physical activity. The TMS consists of 17 items and is scored using a 4-point Likert scale; higher scores indicate a high level of fear of movement. The Turkish validity and reliability study was conducted by Yılmaz et al., and the scale is widely used in clinical and research settings.
2 days

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Karabuk University

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

15 czerwca 2026

Zakończenie podstawowe (Rzeczywisty)

31 sierpnia 2026

Ukończenie studiów (Rzeczywisty)

31 sierpnia 2026

Daty rejestracji na studia

Pierwszy przesłany

10 czerwca 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

11 czerwca 2026

Pierwszy wysłany (Rzeczywisty)

16 czerwca 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

11 września 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

9 września 2026

Ostatnia weryfikacja

1 lipca 2026

Więcej informacji

Terminy związane z tym badaniem

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • KBU-FTR-NC-10

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Opis planu IPD

Data are available from the corresponding author on reasonable request.

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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