Comparative Effects of Four Brief Breathwork and Mindfulness Interventions on Anxiety and Psychological Flexibility: A 4-Arm RCT
NCT07621042 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 240
Last updated 2026-06-04
Summary
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.
Conditions
- Anxiety
- Psychological Flexibility
- Stress
Interventions
- BEHAVIORAL
-
Box Breathing
Individualized box breathing based on CO2 tolerance test. Participants perform a maximal exhale and record the duration (CO2 discard time) to determine their personal cycle interval: 3-4s (0-20s discard), 5-6s (25-45s discard), or 8-10s (50-75s+ discard). Equal-phase cycles of inhale/hold/exhale/hold repeated for 5 minutes daily. Focus on mechanical breath control only.
- BEHAVIORAL
-
Cyclic Sighing
Double nasal inhalation (slow deep inhale + short top-up inhale to maximal lung capacity) followed by slow complete oral exhalation. Repeated continuously for 5 minutes daily. No attentional instructions.
- BEHAVIORAL
-
Mindfulness AH Exhalation
Focused-attention practice with eyes closed. Attention directed to forehead region between the eyes. Each exhalation accompanied by soft audible vocalization of syllable "AH". Distractions managed with internal label "thinking-thinking" followed by attention redirection. Practiced daily for 5 minutes.
- BEHAVIORAL
-
Mindful Cyclic Sighing
Hybrid practice: double nasal inhalation (cyclic sighing mechanics) combined with slow exhalation vocalized as soft audible "AH". Mindfulness instructions include attention to breath sensations and use of "thinking-thinking" label upon distraction. Practiced daily for 5 minutes.
Sponsors & Collaborators
-
Valencian International University (VIU)
lead OTHER
Principal Investigators
-
Isaac Carmona-Rincón, PhD · Valencian International University (VIU)
Study Design
- Allocation
- RANDOMIZED
- Purpose
- BASIC_SCIENCE
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2027-01-31
- Primary Completion
- 2027-03-31
- Completion
- 2027-05-31
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