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The Use of Foot Reflexology in Alleviating Anxiety Symptoms: A Randomized Clinical Trial
This randomized, sham-controlled, parallel, double-blind clinical trial investigates the effects of foot reflexology on anxiety and well-being in adults with anxiety disorders. Participants are randomized (1:1) to receive either standardized foot reflexology or sham massage for 10 sessions (twice per week, 5 weeks). The primary outcome is the change in Beck Anxiety Inventory (BAI) score from baseline to the 10th session. Secondary outcomes include BAI score at 30-day follow-up, relaxation and well-being assessed immediately after each session with the Profile of Mood States (POMS - Brazilian version, Tension-Anxiety subscale), and incidence of adverse events. It is hypothesized that foot reflexology will result in a greater reduction of anxiety symptoms compared to sham massage.
Participants aged 18-60 years with a clinical diagnosis of anxiety (DSM-5) are recruited and randomized 1:1 into two groups: Experimental: standardized foot reflexology protocol targeting reflex points (solar plexus, CNS, pituitary, heart, diaphragm). Sham comparator: foot manipulation and mobilization (sliding, flexion-extension, rotation, traction) without stimulation of reflex points. Both interventions last approximately 15 minutes per session, 10 sessions total (twice per week for 5 weeks). Assessments: BAI at baseline, after 5 sessions, after 10 sessions, and 30-day follow-up. POMS (Tension-Anxiety subscale) immediately after each session (sessions 1-10). Checklist for adverse events (e.g., redness, pain, tingling, transient discomfort). Blinding: Participants, care providers, outcome assessors, and statisticians are blinded to group allocation.
Age
18 - 80 years
Sex
ALL
Healthy Volunteers
No
Centro Universitário Mauricio de Nassau
Vitória da Conquista, Estado de Bahia, Brazil
Start Date
July 30, 2025
Primary Completion Date
November 30, 2025
Completion Date
December 5, 2025
Last Updated
November 28, 2025
44
ESTIMATED participants
Reflexology
OTHER
Sham Reflexology
OTHER
Lead Sponsor
Carlos Germano Dias Santos
NCT07432945
NCT06661460
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT07235852