The Use of Foot Reflexology in Alleviating Anxiety Symptoms: A Randomized Clinical Trial
Phase: NA
Conditions: Anxiety Disorders
Sponsor: Carlos Germano Dias Santos

Study Protocol 
 
Official Title: THE USE OF FOOT REFLEXOLOGY IN ALLEVIATING ANXIETY 
SYMPTOMS: A RANDOMIZED CLINICAL TRIAL 
NCT Number:  
Date: June 26, 2025 
Version: 1.0 
 
 
 

1. Background and Rationale 
Anxiety disorders are among the most prevalent psychiatric conditions 
worldwide, impairing quality of life and daily functioning. Despite effective 
treatments such as pharmacotherapy and cognitive-behavioral therapy, many 
patients remain partially symptomatic or experience side effects. Complementary 
and Integrative Practices (CIP) have gained attention as supportive strategies, 
and reflexology is one of these practices recognized by the Brazilian Unified 
Health System (SUS). 
Foot reflexology is a non-invasive manual technique that applies pressure to 
specific reflex points on the feet, believed to correspond to organs and systems 
in the body. Preliminary studies suggest potential benefits in reducing anxiety 
and promoting relaxation, but further randomized controlled trials with rigorous 
methodology are needed. 
 
2. Objectives 
Primary Objective: 
- To evaluate the effect of foot reflexology on anxiety symptoms, measured by 
the Beck Anxiety Inventory (BAI). 
Secondary Objectives: 
- To assess changes in psychological well-being and relaxation using the 
Tension-Anxiety subscale of the Profile of Mood States (POMS, reduced 
version). 
- To record and analyze adverse effects related to the interventions. 
 
3. Study Design 
This is a randomized, parallel, controlled, double-blind clinical trial with two arms: 
1. Foot reflexology intervention. 
2. Sham reflexology (control group). 
The study will last approximately 5 weeks, with 10 intervention sessions per 
participant. 
 

4. Eligibility Criteria 
Inclusion Criteria: 
- Adults aged 18–80 years. 
- Clinical diagnosis of anxiety disorder (confirmed by physician or psychologist). 
- BAI score ≥ 11 (mild anxiety or higher). 
- Ability to attend all intervention sessions and assessments. 
Exclusion Criteria: 
- Current psychiatric or psychological treatment with medication adjustments in 
the last 30 days. 
- Use of other complementary therapies for anxiety during the study period. 
- History of severe psychiatric disorders (psychosis, bipolar disorder). 
- Foot injuries, ulcers, or contraindications to manual therapy. 
- Pregnancy. 
 
5. Interventions 
Foot Reflexology Group: 
- Protocol based on classical reflexology charts, applying pressure to reflex 
points related to stress and anxiety regulation. Each session lasts approximately 
15 minutes per foot, totaling 30 minutes. 
Sham Reflexology Group: 
- Protocol involving superficial sliding movements and joint mobilization of the 
foot (hindfoot, midfoot, forefoot), without stimulation of reflex points. Movements 
include 
flexion, 
extension, 
circumduction, 
and 
gentle 
traction 
of 
metatarsophalangeal, tarsometatarsal, and ankle joints. Each session lasts 30 
minutes. 
 
6. Outcome Measures 
Primary Outcome: 
- Reduction in anxiety symptoms assessed by Beck Anxiety Inventory (BAI). 
- Score range: 0 to 63. 
- Higher scores indicate worse anxiety. 

- Time points: baseline, after session 5, after session 10. 
Secondary Outcomes: 
- Tension-Anxiety Subscale of the Profile of Mood States (POMS – reduced 
version). 
- Score range: 0 to 36. 
- Higher scores indicate worse tension-anxiety. 
- Time points: after each of the 10 sessions. 
- Adverse effects. 
- Recorded during and after each session. 
- Frequency and intensity analyzed descriptively. 
 
7. Randomization and Blinding 
Participants will be randomized into intervention or sham groups using a 
computer-generated randomization list (randomization.com). Allocation will be 
concealed in sealed opaque envelopes. 
Blinding: 
- Participants will not be informed of the intervention type (reflexology or sham). 
- Therapists will be trained but informed only that they are applying a “foot 
massage technique,” with no access to study allocation. They will not 
communicate with each other. 
- Outcome assessors and data analysts will remain blinded to group allocation. 
 
8. Data Collection and Management 
Data will be collected at baseline and throughout the intervention sessions. Each 
participant will be assigned an anonymous code. Data will be stored in password-
protected electronic files accessible only to the research team. 
 
9. Statistical Analysis Plan 
Descriptive statistics (mean ± SD) will be used for quantitative variables. 
- Primary outcome (BAI): Repeated measures ANOVA (Group × Time) with post-
hoc Bonferroni. 

- Secondary outcomes (POMS): Repeated measures ANOVA (Group × Time). 
- Adverse effects: Frequency distribution and Chi-square tests. 
Significance level: p < 0.05. SPSS (IBM, v.29) will be used. 
 
10. Risks and Benefits 
Risks: Mild local reactions in the feet, such as redness, sensitivity, discomfort, or 
muscle soreness, which typically resolve within 48–72 hours. Transient tingling 
may occur. Serious adverse effects are not expected. 
Benefits: Possible reduction in anxiety symptoms, improved relaxation and well-
being, and contribution to scientific knowledge about reflexology. 
 
11. Ethical Considerations 
The study will be conducted in accordance with the Declaration of Helsinki and 
approved by the Institutional Ethics Committee. All participants will provide 
written informed consent before enrollment. 
 
12. References 
Beck AT, Epstein N, Brown G, Steer RA. An inventory for measuring clinical 
anxiety: Psychometric properties. J Consult Clin Psychol. 1988;56(6):893–897. 
doi:10.1037/0022-006X.56.6.893 
 
Nunes MF, et al. Psychometric properties of the Brazilian Portuguese version of 
the Profile of Mood States (POMS). Psicol Reflex Crit. 2013;26(4):645–655. 
doi:10.1590/S0102-79722013000400001 
 
Vardanjani AE, et al. Effect of foot reflexology on anxiety and physiological 
parameters in patients undergoing coronary artery bypass graft surgery. Iran J 
Nurs Midwifery Res. 2013;18(6):443–448. 
Bagheri-Nesami M, et al. The effects of foot reflexology on hospital anxiety and 
depression 
in 
female 
cancer 
patients. 
Iran 
Red 
Crescent 
Med 
J. 
2014;16(5):e15929. doi:10.5812/ircmj.15929