Effect of Foot Reflexology on Anxiety

NCT ID: NCT07161102

Last Updated: 2025-11-28

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-30
• Study Completion Date: 2025-12-05

Brief Summary

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.

Conditions

Anxiety Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Foot Reflexology

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.

Group Type: EXPERIMENTAL

Reflexology

Intervention Type: 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

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.

Group Type: SHAM_COMPARATOR

Sham Reflexology

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Carlos Germano Dias Santos

OTHER

Sponsor Role: lead

Responsible Party

Carlos Germano Dias Santos

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Centro Universitário Mauricio de Nassau

Vitória da Conquista, Estado de Bahia, Brazil

Countries

Brazil

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

UNINASSAU-REFLEXO-GERMANO-2025

Identifier Type: -

Identifier Source: org_study_id