Anxiety Disorders
Conditions
Keywords
Anxiety, Reflexology, Foot Reflexology, Complementary Therapies, Integrative Health, POMS, BAI, Sham Massage
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.
Interventions
OTHERReflexology
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.
OTHERSham 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.
Sponsors
Carlos Germano Dias Santos
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reduction of Anxiety Symptoms (BAI) | 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
| Measure | Time frame | Description |
|---|---|---|
| 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). | 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. |
| Recording of adverse effects related to the intervention | 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). |
Countries
Brazil
Outcome results
None listed