Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 3:37 AM
Ignite Modification Date:
2025-12-25 @ 3:37 AM
NCT ID:
NCT07161102
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.
Study:
NCT07161102
Study Brief:
Protocol Section:
NCT07161102