the Effect of Reflexology in Migraine Patients

NCT ID: NCT06828315

Last Updated: 2025-02-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

78 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-10

Study Completion Date

2025-02-10

Brief Summary

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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.

Detailed Description

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Conditions

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Reflexology Migraine Pain Fatigue Quality of Life

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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experimental group

reflexology was applied to the experimental group

Group Type EXPERIMENTAL

Reflexology

Intervention Type 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.

control group

reflexology was not applied to the control group

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Muş Alparslan University

OTHER

Sponsor Role lead

Responsible Party

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Cihat Demirel

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Cihat Demirel

Role: PRINCIPAL_INVESTIGATOR

Muş Alparslan University

Locations

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Muş Alparslan University

Muş, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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migraine

Identifier Type: -

Identifier Source: org_study_id

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