Effect of Brief Breathwork and Mindfulness Interventions on Anxiety, Psychological Flexibility and Physiological Variables in Spanish-Speaking University Students: a Four-Arm Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 240
- 主要终点
- State Anxiety (STAI-E)
研究概览
简要总结
This four-arm, single-blind randomized controlled trial examines the effects of four brief daily 5-minute practices over 28 days on psychological flexibility and physiological variables in Spanish-speaking adults. Participants will be randomly assigned to one of four groups: Box Breathing, Cyclic Sighing, Mindfulness focused on exhalation with the syllable "AH", or Conscious Cyclic Sighing. Outcomes include state and trait anxiety (STAI), positive and negative affect (PANAS), psychological flexibility (MPFI-24, Psy-Flex), and physiological variables (heart rate, respiratory rate, heart rate variability). Assessments are conducted at baseline, daily during the 28-day intervention, at post-intervention (day 31), and at 2-month follow-up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
盲法说明
Participants are blinded to study hypotheses and group comparisons. All interventions are presented as equally valid wellness practices. Investigators and outcome assessors are not masked.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age between 18 and 65 years (inclusive)
- •Native Spanish speaker or fluent in Spanish (sufficient to understand audio instructions and complete psychometric questionnaires)
- •Stable internet access and an electronic device (smartphone, tablet, or computer)
- •Ability to provide informed consent and commitment to the 31-day protocol and 2-month follow-up
排除标准
- •Active diagnosis of severe or chronic respiratory disease that prevents safe performance of breathing exercises (e.g., advanced COPD, severe uncontrolled asthma, cystic fibrosis)
- •Current diagnosis of severe psychiatric disorder (e.g., psychotic spectrum disorders, acute-phase bipolar disorder, severe major depression with suicidal risk)
- •Any acute medical condition contraindicated for voluntary alteration of breathing patterns
研究组 & 干预措施
Box Breathing
Daily 5-minute box breathing with individualized timing based on a CO2 tolerance test. Participants perform a maximal exhale and record the duration; this determines their personal inhale/hold/exhale/hold intervals (3-4s, 5-6s, or 8-10s). Equal-phase cyclic breathing with exclusive focus on mechanical control and counting.
干预措施: Box Breathing (Behavioral)
Cyclic Sighing
Daily 5-minute cyclic sighing. Participants inhale slowly through the nose, then take a second shorter nasal inhale to maximally fill the lungs, followed by a slow, complete oral exhalation. This double-inhale/long-exhale pattern is repeated continuously for 5 minutes. No mindfulness or attentional instructions are given.
干预措施: Cyclic Sighing (Behavioral)
Mindfulness AH Exhalation
Daily 5-minute focused-attention mindfulness practice. Participants sit or lie down, close their eyes, and direct attention to the forehead region between the eyes. On each exhale, they softly vocalize the syllable "AH" aloud (gentle, unforced audible sound). When distracted, they use the internal label "thinking-thinking" and redirect attention to the breath and then to the forehead region. Practice continues for 5 minutes.
干预措施: Mindfulness AH Exhalation (Behavioral)
Mindful Cyclic Sighing
Daily 5-minute hybrid practice combining cyclic sighing mechanics with mindfulness instructions. Participants inhale slowly through the nose, take a second shorter nasal inhale to maximally fill the lungs, then exhale slowly while softly vocalizing the syllable "AH" aloud (gentle, unforced). Attention is directed to the breath and the sensation of release during exhalation. When distracted, participants use the internal label "thinking-thinking" and redirect attention back to the breath. Practice continues for 5 minutes.
干预措施: Mindful Cyclic Sighing (Behavioral)
结局指标
主要结局
State Anxiety (STAI-E)
时间窗: Baseline (Day 0), daily pre- and post-practice (Days 1-28), post-intervention (Day 31), and 2-month follow-up
State anxiety measured with the State-Trait Anxiety Inventory - State subscale (STAI-E). 20 items rated on a 4-point Likert scale (0-3). Higher scores indicate greater anxiety. Spanish validated version (Guillen-Riquelme \& Buela-Casal, 2011).
次要结局
- Positive and Negative Affect (PANAS)(Baseline (Day 0), daily pre- and post-practice (Days 1-28), post-intervention (Day 31), and 2-month follow-up)
- Psychological Flexibility (MPFI-24)(Baseline (Day 0), post-intervention (Day 31), and 2-month follow-up)
- Psychological Flexibility (Psy-Flex)(Baseline (Day 0), daily (Days 1-28), post-intervention (Day 31), and 2-month follow-up)
- Trait Anxiety (STAI-R)(Baseline (Day 0), post-intervention (Day 31), and 2-month follow-up)
研究者
Isaac Carmona-Rincón
Researcher, PROCESS Lab
Valencian International University (VIU)