Fatigue, Migraine, Pain, Quality of Life, Reflexology
Conditions
Brief summary
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.
Interventions
OTHERReflexology
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.
Sponsors
Muş Alparslan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
1. Being between the ages of 18-60 (to conduct the study with adult individuals and to minimise the effect of age-related variables) 2. Being diagnosed with migraine 3. Having experienced at least 2 migraine attacks in the last 6 months (to ensure a homogenous group among patients with more chronic or episodic migraine) 4. Migraine with a severity of 4 or more with VAS (Visual Analogue Scale) (To prevent mild headaches from affecting the study) 5. Having experienced at least 2 migraine attacks in the last 6 months (to ensure a homogenous group among patients with more chronic or episodic migraine) 6. To participate and continue to work as a volunteer
Exclusion criteria
1. For female participants: Being pregnant or breastfeeding (as hormone changes may change the effect of migraine and reflexology) 2. Having another chronic neurological disease (epilepsy, MS, Parkinson's, etc.) (to avoid the effect of symptoms that may be confused with migraine) 3. Being treated with another alternative medicine method (acupuncture, biofeedback, etc.) at the same time (to measure the independent effect of reflexology) 4. Regular use of Botox, nerve blockade or invasive treatment for migraine in the last 3 months (to reduce the influence of external factors on migraine severity) 5. Severe psychiatric disorders (schizophrenia, bipolar disorder, etc.) or a history of severe depression/anxiety (to isolate the effect of stress and psychological factors on reflexology) 6. No previous serious side effects or intolerance to reflexology (important for safety) 7. Diabetic neuropathy, severe peripheral neuropathy or severe dermatological disorders (infection, open wound, etc.) in the foot area (as it may affect the applicability of reflexology)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analog Scale (VAS) | At the end of the 5-week intervention | 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. |
| Fatigue Severity Scale (FSS) | At the end of the 5-week intervention | 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. |
| 24-Hour Migraine-Specific Quality of Life Questionnaire (24 h MQoLQ) | At the end of the 5-week intervention | 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. |
Countries
Turkey (Türkiye)
Contacts
PRINCIPAL_INVESTIGATORCihat Demirel
Muş Alparslan University
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 42.76 Year STANDARD_DEVIATION 12.23 |
| Baseline Fatigue Severity | 43.10 Score (9-63) STANDARD_DEVIATION 5.73 |
| Baseline Migraine-Specific Quality of Life | 67.59 Score (15-105) STANDARD_DEVIATION 6.01 |
| Baseline Pain Intensity (Visual Analog Scale) | 7.42 Score (range 0-10) STANDARD_DEVIATION 1.37 |
| Race and Ethnicity Not Collected | 0 Participants |
| Sex: Female, Male Female | 25 Participants |
| Sex: Female, Male Male | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 39 | 0 / 39 |
| other Total, other adverse events | 0 / 39 | 0 / 39 |
| serious Total, serious adverse events | 0 / 39 | 0 / 39 |
Outcome results
None listed