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The aim of this randomised controlled trial was to evaluate the effect of foot reflexology on pain intensity, fatigue and quality of life in migraine patients.
The main questions it aims to answer are:
Is foot reflexology effective in reducing pain intensity in migraine patients? Is foot reflexology effective in reducing the fatigue level of migraine patients? Is foot reflexology effective in improving the quality of life of migraine patients? Comparison group: The researchers will evaluate the effects of foot reflexology by comparing the group receiving reflexology intervention with the control group receiving only routine treatment.
Participants were selected according to the following criteria:
Intervention group: Individuals diagnosed with migraine will receive foot reflexology twice a week for a total of 10 sessions.
Control group: No additional intervention will be applied to this group, only their routine treatment and medical follow-up will continue.
Both groups will be evaluated at the beginning and at the end of the study with the Patient Information Form, Migraine 24-Hour Quality of Life Scale (QoLQS), Visual Analogue Scale (VAS) and Fatigue Severity Scale (FSS). After the completion of the study, reflexology will be applied to patients in the control group who are willing to receive reflexology.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| experimental group | Experimental | reflexology was applied to the experimental group |
|
| control group | No Intervention | reflexology was not applied to the control group |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Reflexology | Other | Reflexology is a practice based on the fact that the organs in the body are connected to the reflex areas in the hands and feet. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analog Scale (VAS) | Pain intensity was assessed using the Visual Analog Scale (VAS) for Pain. The Visual Analog Scale is a unidimensional measure of perceived pain intensity. It consists of a 10-centimeter horizontal line anchored by two descriptors: "no pain" (0) and "worst imaginable pain" (10). Participants mark a point on the line corresponding to their perceived pain intensity, resulting in a score ranging from 0 to 10. Higher scores indicate greater pain severity and represent a worse outcome. Lower scores indicate less pain and represent a better outcome. | At the end of the 5-week intervention |
| Fatigue Severity Scale (FSS) | The Fatigue Severity Scale (FSS) will be used to evaluate changes in participants' fatigue levels. The FSS consists of nine items scored from 1 to 7, with higher scores indicating greater fatigue severity. The total score ranges from a minimum of 9 to a maximum of 63. | At the end of the 5-week intervention |
| 24-Hour Migraine-Specific Quality of Life Questionnaire (24 h MQoLQ) | 24-Hour Migraine-Specific Quality of Life Questionnaire (24 h MQoLQ) will assess changes in migraine-specific quality of life. It includes five subscales: Migraine Symptoms, Emotions and Concerns, Work Functionality, Social Functionality, and Energy/Vitality. Higher scores indicate better quality of life. The total score ranges from a minimum of 15 to a maximum of 105. | At the end of the 5-week intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cihat Demirel | Muş Alparslan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Muş Alparslan University | Muş | Turkey (Türkiye) |
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| ID | Title | Description |
|---|---|---|
| FG000 | Experimental Group | reflexology was applied to the experimental group Reflexology: Reflexology is a practice based on the fact that the organs in the body are connected to the reflex areas in the hands and feet. |
| FG001 | Control Group | reflexology was not applied to the control group |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Pre-Intervention (Baseline) |
| |||||||||||||
| Post-Intervention (At the End of Week 5) |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Experimental Group | reflexology was applied to the experimental group Reflexology: Reflexology is a practice based on the fact that the organs in the body are connected to the reflex areas in the hands and feet. |
| BG001 | Control Group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Visual Analog Scale (VAS) | Pain intensity was assessed using the Visual Analog Scale (VAS) for Pain. The Visual Analog Scale is a unidimensional measure of perceived pain intensity. It consists of a 10-centimeter horizontal line anchored by two descriptors: "no pain" (0) and "worst imaginable pain" (10). Participants mark a point on the line corresponding to their perceived pain intensity, resulting in a score ranging from 0 to 10. Higher scores indicate greater pain severity and represent a worse outcome. Lower scores indicate less pain and represent a better outcome. | Posted | Mean | Standard Deviation | Score (0-10) | At the end of the 5-week intervention |
|
5 week
Adverse events were actively monitored throughout the 5-week intervention period at each study visit through participant self-report and clinical assessment.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Experimental Group | reflexology was applied to the experimental group Reflexology: Reflexology is a practice based on the fact that the organs in the body are connected to the reflex areas in the hands and feet. |
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Single-center design may limit generalizability. The absence of a placebo (sham reflexology) control group may not fully account for expectancy or nonspecific effects. Blinding was limited to outcome assessment. Additionally, no long-term follow-up was conducted to evaluate the durability of the intervention effects.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Assistant Professor Cihat DEMİREL | Muş Alparslan University | +90 5536186477 | cihatdemirel34@gmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Feb 23, 2025 | Feb 12, 2026 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| D010146 | Pain |
| D005221 | Fatigue |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D026201 | Musculoskeletal Manipulations |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
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| NOT COMPLETED |
|
reflexology was not applied to the control group |
| BG002 | Total | Total of all reporting groups |
| Year |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Baseline Pain Intensity (Visual Analog Scale) | Pain intensity was assessed using the Visual Analog Scale (VAS) for Pain. The Visual Analog Scale is a unidimensional measure of perceived pain intensity. It consists of a 10-centimeter horizontal line anchored by two descriptors: "no pain" (0) and "worst imaginable pain" (10). Participants mark a point on the line corresponding to their perceived pain intensity, resulting in a score ranging from 0 to 10. Higher scores indicate greater pain severity and represent a worse outcome. Lower scores indicate less pain and represent a better outcome. | Mean | Standard Deviation | Score (range 0-10) |
|
| Baseline Fatigue Severity | Fatigue severity was assessed using the Fatigue Severity Scale (FSS). The FSS is a 9-item self-report instrument designed to evaluate the severity and impact of fatigue over the previous month. Each item is rated on a 7-point Likert scale ranging from 1 (strongly disagree) to 7 (strongly agree). The total score is calculated by summing the scores of the 9 items, resulting in a total score range of 9 to 63. Higher total scores indicate greater fatigue severity and represent a worse outcome. Scores ≥36 are considered indicative of clinically significant fatigue. | Mean | Standard Deviation | Score (9-63) |
|
| Baseline Migraine-Specific Quality of Life | Quality of life was assessed using the 24-Hour Migraine Quality of Life Questionnaire (24-Hr MQoLQ), a 15-item self-report scale measuring migraine-related quality of life across five domains: Migraine Symptoms, Feelings and Concerns, Work Functionality, Social Functionality, and Energy and Vitality. Items are rated on a 7-point Likert scale. Subscale scores range from 3 to 21, and the total score is obtained by summing all items (range: 15-105). Higher scores indicate better quality of life (better outcome), whereas lower scores indicate poorer quality of life. | Mean | Standard Deviation | Score (15-105) |
|
| OG001 | Control Group | reflexology was not applied to the control group |
|
|
| Primary | Fatigue Severity Scale (FSS) | The Fatigue Severity Scale (FSS) will be used to evaluate changes in participants' fatigue levels. The FSS consists of nine items scored from 1 to 7, with higher scores indicating greater fatigue severity. The total score ranges from a minimum of 9 to a maximum of 63. | Posted | Mean | Standard Deviation | Score (9-63) | At the end of the 5-week intervention |
|
|
|
| Primary | 24-Hour Migraine-Specific Quality of Life Questionnaire (24 h MQoLQ) | 24-Hour Migraine-Specific Quality of Life Questionnaire (24 h MQoLQ) will assess changes in migraine-specific quality of life. It includes five subscales: Migraine Symptoms, Emotions and Concerns, Work Functionality, Social Functionality, and Energy/Vitality. Higher scores indicate better quality of life. The total score ranges from a minimum of 15 to a maximum of 105. | Posted | Mean | Standard Deviation | Score (15-105) | At the end of the 5-week intervention |
|
|
|
| 0 |
| 39 |
| 0 |
| 39 |
| 0 |
| 39 |
| EG001 | Control Group | reflexology was not applied to the control group | 0 | 39 | 0 | 39 | 0 | 39 |
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| D009422 | Nervous System Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |