Foot Reflexology as an Adjunctive Therapy in Migraine Management: A Randomized Controlled Trial on Pain, Fatigue, and Quality of Life
Phase: NA
Conditions: Reflexology, Migraine, Pain, Fatigue, Quality of Life
Sponsor: Muş Alparslan University

STUDY PROTOCOL, STATISTICAL ANALYSIS
PLAN AND INFORMED CONSENT FORM
Official Title:
Foot Reflexology as an Adjunctive Therapy in Migraine Management: A Randomized Controlled
Trial on Pain, Fatigue, and Quality of Life
NCT Number: NCT06828315
Date of Document: February 23, 2025
1. Background and Rationale
Migraine is a chronic neurovascular disorder characterized by recurrent headache attacks and
functional impairment. Complementary therapies such as foot reflexology have been proposed as
adjunctive interventions to reduce symptom burden. High-quality randomized controlled trials
evaluating its effects on pain, fatigue, and quality of life are limited.
2. Objectives
Primary Objective: To evaluate the effect of foot reflexology on pain intensity in individuals with
migraine. Secondary Objectives: To assess the effect on fatigue severity and migraine-related
quality of life.
3. Study Design
Single-blind, parallel-group randomized controlled trial conducted at a state hospital neurology
clinic. Participants were randomized 1:1 to intervention (reflexology + standard care) or control
(standard care). Assessments were conducted at baseline and after 5 weeks.
4. Study Population
Inclusion Criteria: Age 18–60 years; ICHD-3 migraine diagnosis; ≥2 attacks in past 6 months; VAS
≥4; written informed consent. Exclusion Criteria: Pregnancy; neurological disorders; prophylactic
migraine therapy within 3 months; prior reflexology; recent alternative therapies; severe psychiatric
disorders; contraindicating foot conditions.
5. Sample Size

Calculated using G*Power (α = 0.05; power = 90%). Minimum 38 participants per group required.
Total enrolled: 78 (39 per group).
6. Randomization
Computer-generated allocation by independent researcher using sealed opaque envelopes.
7. Interventions
Intervention group received 10 reflexology sessions (twice weekly for 5 weeks; 30 minutes per
session) in addition to standard care. Control group continued standard care.
8. Outcome Measures
Primary: Visual Analog Scale (0–10 cm). Secondary: Fatigue Severity Scale (9–63 total score);
24-Hour Migraine Quality of Life Questionnaire (15–105 total score).
9. Safety Monitoring
Adverse events were monitored at each study visit. Reflexology is low-risk; mild temporary
discomfort may occur.
10. Statistical Analysis Plan
Analyses performed using SPSS v23.0. Descriptive statistics calculated. Normality assessed using
Shapiro–Wilk test. Between-group comparisons: chi-square, independent t-test or Mann–Whitney U
test. Within-group comparisons: paired t-test or Wilcoxon signed-rank test. Significance level set at
p < 0.05. No interim analyses conducted.
11. Ethics
Approved by Scientific Research and Publication Ethics Committee (Approval No: 46; October 16,
2024). Conducted in accordance with the Declaration of Helsinki. Written informed consent
obtained from all participants.

INFORMED CONSENT FORM
Invitation to Participate
You are invited to participate in a research study evaluating the effects of foot reflexology on
migraine-related pain, fatigue, and quality of life.
Purpose of the Study
To examine whether foot reflexology has beneficial effects on migraine-related outcomes.
Study Procedures
Participants will be randomly assigned to intervention or control group. Intervention group receives
10 sessions over five weeks. Control group continues standard care. Questionnaires will be
completed before and after the study.
Potential Benefits
Possible reduction in pain and fatigue and improved quality of life. No guarantee of benefit.
Potential Risks
Mild temporary discomfort may occur.
Confidentiality
All data will remain confidential and securely stored.
Voluntary Participation
Participation is voluntary and withdrawal is permitted at any time without penalty.
Statement of Consent
I have read and understood the information above and voluntarily agree to participate.
Participant’s Name:
Signature:
Date:
Researcher’s Name:

Signature:
Date: