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Completed

NCT Number: NCT07028684

Effects of Foot Reflexology Massage in 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.

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Key information

Conditions

Migraine Disease Brain Diseases Central Nervous System Diseases Headache Headache Disorders Headache Disorders, Primary Migraine Disorders Nervous System Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Karabuk University

Karabük, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Reflexology Massage

Other

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Headache Impact Test

    Time frame: Five weeks

    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.

  2. Pittsburgh Sleep Quality Index

    Time frame: Five weeks

    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.

  3. Migraine disability assessment

    Time frame: Five weeks

    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.

  4. 24-h Migraine Quality of Life Questionnaire

    Time frame: Five weeks

    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.

Sponsors and collaborators

Lead sponsor

Karabuk University

Other

Registry information

Official study title

Effects of Foot Reflexology Massage in Pain, Sleep and Quality of Life in Females With Migraine

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Jun 19, 2025
Registry last updated
Apr 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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