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Набор по приглашению NCT07161102

Effect of Foot Reflexology on Anxiety

Без фазы С лечением Anxiety Disorders

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Reflexology, Sham Reflexology.
Кому может быть актуально
Состояния в реестре: Anxiety Disorders. Базовые параметры: 18 лет — 80 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Бразилия
Следующий шаг
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Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

  • Другое 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.
  • Другое 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.

Первичные конечные точки

  • Reduction of Anxiety Symptoms (BAI) [Срок оценки: Baseline, after 5 sessions and after 10 sessions (approximately 5 weeks).]
Вторичные конечные точки (2)
  • Reduction of tension-anxiety levels (Profile of Mood States - POMS, reduced version) [Срок оценки: Baseline, after 5 sessions (approximately 2.5 weeks), and after 10 sessions (approximately 5 weeks).]
  • Recording of adverse effects related to the intervention [Срок оценки: Throughout the intervention period (10 sessions - approximately 5 weeks).]

Критерии участия

Критерии включения

  • 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.

Критерии исключения

  • 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Четверное слепое
Основная цель
Лечение

Центры проведения

Бразилия · 1 центр
  • Centro Universitário Mauricio de Nassau — Vitória da Conquista

Идентификаторы

NCT: NCT07161102 · UNINASSAU-REFLEXO-GERMANO-2025

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗