Effect of Foot Reflexology on Anxiety (REFLEX-ANS)

Carlos Germano Dias Santos

Status: Invitation-only

Conditions: Anxiety Disorders

Treatments: Other: Sham Reflexology; Other: Reflexology

Study type: Interventional

Funder types: Other

Identifiers

NCT07161102

UNINASSAU-REFLEXO-GERMANO-2025

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 44 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age between 18 and 60 years.
• Clinical diagnosis of anxiety disorder confirmed by a healthcare professional (physician or psychologist).
• Score ≥ 11 on the Beck Anxiety Inventory (BAI) in the initial assessment.
• Availability to participate in the 10 proposed sessions.
• Signed informed consent.

Exclusion criteria

• Current use of benzodiazepines, antidepressants, or other psychotropic medications initiated less than 3 months ago.
• Associated diagnosis of psychotic disorder, bipolar disorder, or active suicidal ideation.
• Presence of serious or decompensated medical conditions (e.g., severe cardiovascular disease, uncontrolled epilepsy).
• Simultaneous participation in other complementary therapies (e.g., acupuncture, auriculotherapy, yoga, Reiki) during the study period.
• Pregnant or lactating women.
• Individuals with foot injuries, infections, or diseases that prevent foot reflexology.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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44 participants in 2 patient groups

Foot Reflexology

Experimental group

Description:

Participants will receive 10 foot reflexology sessions, administered twice a week, each lasting approximately 30 minutes. The technique will be performed on specific reflexology points on the feet, according to protocols described in the scientific literature, aiming to reduce anxiety symptoms.

Treatment:

Other: Reflexology

Sham Reflexology

Sham Comparator group

Description:

Participants will receive 10 simulated intervention sessions, administered twice a week, each lasting approximately 30 minutes. The technique will consist of light, superficial touches to the feet, without stimulating reflexology points, with the aim of simulating the intervention without specific therapeutic effects.

Treatment:

Other: Sham Reflexology