Effect of Foot Reflexology on Anxiety

NCT07161102 | Enrolling By Invitation DMC

• 1 other identifier: UNINASSAU-REFLEXO-GERMANO-2025
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety Disorders

Keywords

Anxiety; Reflexology; Foot Reflexology; Complementary Therapies; Integrative Health; POMS; BAI; Sham Massage

Outcome Measures

Primary Outcomes (1)

• Reduction of Anxiety Symptoms (BAI)

  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.

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

Secondary Outcomes (2)

• Reduction of tension-anxiety levels (Profile of Mood States - POMS, reduced version)

  Baseline, after 5 sessions (approximately 2.5 weeks), and after 10 sessions (approximately 5 weeks).

• Recording of adverse effects related to the intervention

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

Study Arms (2)

Foot Reflexology

EXPERIMENTAL

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.

Other: Reflexology

Sham Reflexology

SHAM COMPARATOR

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.

Other: Sham Reflexology

Interventions

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.

Foot Reflexology

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.

Sham Reflexology

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Carlos Germano Dias Santos: lead

Study Sites (1)

Centro Universitário Mauricio de Nassau

Vitória da Conquista, Estado de Bahia, 45005338, Brazil

Location

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Musculoskeletal Manipulations

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 25, 2025
• First Posted: September 8, 2025
• Study Start: July 30, 2025
• Primary Completion: November 30, 2025
• Study Completion: December 5, 2025
• Last Updated: November 28, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)