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Enrolling by invitation NCT07161102

Effect of Foot Reflexology on Anxiety

No phase Interventional Anxiety Disorders

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Reflexology, Sham Reflexology.
Who it may be relevant to
Registry conditions: Anxiety Disorders. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Brazil
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

The Use of Foot Reflexology in Alleviating Anxiety Symptoms: A Randomized Clinical Trial

Overview

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.

Detailed 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.

Interventions

  • Other Reflexology
    A complementary technique that involves applying pressure to reflexology points on the feet. In this study, foot reflexology will be applied in 10 sessions, twice a week, for 30 minutes, aiming to reduce anxiety symptoms.
  • Other Sham Reflexology
    A simulated procedure consisting of superficial and random maneuvers on the feet, without stimulation of specific reflexology points. Ten sessions will be conducted twice a week, each lasting 30 minutes, for placebo control purposes.

Primary outcome measures

  • Reduction of Anxiety Symptoms (BAI) [Time frame: Baseline, after 5 sessions and after 10 sessions (approximately 5 weeks).]
Secondary outcome measures (2)
  • Reduction of tension-anxiety levels (Profile of Mood States - POMS, reduced version) [Time frame: Baseline, after 5 sessions (approximately 2.5 weeks), and after 10 sessions (approximately 5 weeks).]
  • Recording of adverse effects related to the intervention [Time frame: Throughout the intervention period (10 sessions - approximately 5 weeks).]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

Brazil · 1 center
  • Centro Universitário Mauricio de Nassau — Vitória da Conquista

Identifiers

NCT: NCT07161102 · UNINASSAU-REFLEXO-GERMANO-2025

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗