The Use of Foot Reflexology in Alleviating Anxiety Symptoms: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Reduction of Anxiety Symptoms (BAI)
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Reflexology (Other)
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.
干预措施: Sham Reflexology (Other)
结局指标
主要结局
Reduction of Anxiety Symptoms (BAI)
时间窗: 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.
次要结局
- 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).)
研究者
Carlos Germano Dias Santos
Principal Investigator
Centro Universitário Maurício de Nassau