The Effect of Foot Reflexology in Women With Migraine
2026年9月9日 更新者：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.
調査の概要
詳細な説明
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.
研究の種類
介入
入学 (実際)
36
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Karabük Province
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Karabük、Karabük Province、トルコ（Türkiye）、78050
- Karabuk University
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
健康ボランティアの受け入れ
はい
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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介入なし：control group
The control group will not receive any foot reflexology therapy or other treatment intervention.
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実験的：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.
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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 |
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偽コンパレータ：Sham group
superficial massage group
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The sham group received a superficial massage on the soles of the feet, avoiding targeting reflexology points.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Headache Impact Test (HIT-6)
時間枠：2 days
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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.
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2 days
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Migraine Disability Assessment Scale
時間枠：2 days
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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.
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2 days
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International Physical Activity Questionnaire-Short Form
時間枠：2 days
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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.
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2 days
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Beck Anxiety Scale
時間枠：2 days
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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.
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2 days
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Assessment of postural control
時間枠：2 days
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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.
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2 days
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Tampa Kinesiophobia Scale
時間枠：2 days
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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.
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2 days
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研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2026年6月15日
一次修了 (実際)
2026年8月31日
研究の完了 (実際)
2026年8月31日
試験登録日
最初に提出
2026年6月10日
QC基準を満たした最初の提出物
2026年6月11日
最初の投稿 (実際)
2026年6月16日
学習記録の更新
投稿された最後の更新 (実際)
2026年9月11日
QC基準を満たした最後の更新が送信されました
2026年9月9日
最終確認日
2026年7月1日
詳しくは
本研究に関する用語
その他の研究ID番号
- KBU-FTR-NC-10
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
いいえ
IPD プランの説明
Data are available from the corresponding author on reasonable request.
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