- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07651839
The Effect of Foot Reflexology in Women With Migraine
The Effect of Foot Reflexology on Pain, Disability, Anxiety, Kinesiophobia, and Postural Control in Women With Migraine
연구 개요
상세 설명
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Karabük Province
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Karabük, Karabük Province, 터키 (Türkiye), 78050
- Karabuk University
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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간섭 없음: control group
The control group will not receive any foot reflexology therapy or other treatment intervention.
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실험적: 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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가짜 비교기: 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Headache Impact Test (HIT-6)
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- KBU-FTR-NC-10
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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