- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07651839
The Effect of Foot Reflexology in Women With Migraine
The Effect of Foot Reflexology on Pain, Anxiety, Kinesiophobia, and Postural Control in Women With Migraine
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Nurcan Contarli, Doctor
- Phone Number: +90370 418 9171
- Email: nurcancontarli@karabuk.edu.tr
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Being a woman between the ages of 18 and 45
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: control group
The control group will not receive any foot reflexology therapy or other treatment intervention.
|
|
|
Experimental: 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.
|
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 |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Headache Impact Test (HIT-6)
Time Frame: 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
Time Frame: 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.
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2 days
|
|
International Physical Activity Questionnaire-Short Form
Time Frame: 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
Time Frame: 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.
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2 days
|
|
Assessment of postural control
Time Frame: 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
Time Frame: 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.
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2 days
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KBU-FTR-NC-10
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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