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NCT Number: NCT07161102

Effect of Foot Reflexology on Anxiety

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centro Universitário Mauricio de Nassau

Vitória da Conquista, Estado de Bahia, 45005338, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Reflexology

Other

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.

Sham Reflexology

Other

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 outcomes

  1. Reduction of Anxiety Symptoms (BAI)

    Time frame: Baseline, after 5 sessions and after 10 sessions (approximately 5 weeks).

    Anxiety symptom variation was assessed using the Beck Anxiety Inventory (BAI), a validated and widely used scale for measuring the intensity of anxiety symptoms. The total score ranges from 0 to 63, with higher scores indicating greater anxiety. The analysis will compare the scores obtained in the first session (baseline), the fifth session, and the tenth intervention session.

Secondary outcomes

  1. 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).

    Assessment of subjective perception of relaxation and psychological well-being using the Tension-Anxiety subscale of the Profile of Mood States (POMS) - Reduced Version, validated for Portuguese. Scores range from 0 to 36, with higher scores indicating greater tension and anxiety and lower scores indicating greater relaxation and well-being.

  2. Recording of adverse effects related to the intervention

    Time frame: Throughout the intervention period (10 sessions - approximately 5 weeks).

    Systematic monitoring and recording of any adverse effects reported during or after foot reflexology or sham reflexology sessions, including pain, discomfort, or unexpected reactions. Outcomes will be categorized by frequency (number of participants affected) and intensity (mild, moderate, severe).

Sponsors and collaborators

Lead sponsor

Carlos Germano Dias Santos

Other

Registry information

Official study title

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

Acronym: REFLEX-ANS

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Sep 8, 2025
Registry last updated
Nov 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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