Comparative Effects of Four Brief Breathwork and Mindfulness Interventions on Anxiety and Psychological Flexibility: A 4-Arm RCT (BREATH-4)
2026年6月2日 更新者：Isaac Carmona-Rincón、Valencian International University (VIU)
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
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.
調査の概要
状態
まだ募集していません
研究の種類
介入
入学 (推定)
240
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Isaac Carmona-Rincón, PhD
- 電話番号：+34 618 187 325
- メール：isaac.carmona@professor.universidadviu.com
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
はい
説明
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：基礎科学
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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.
|
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.
|
|
実験的：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.
|
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.
|
|
実験的：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.
|
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.
|
|
実験的：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.
|
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.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
State Anxiety (STAI-E)
時間枠：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).
|
Baseline (Day 0), daily pre- and post-practice (Days 1-28), post-intervention (Day 31), and 2-month follow-up
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Positive and Negative Affect (PANAS)
時間枠：Baseline (Day 0), daily pre- and post-practice (Days 1-28), post-intervention (Day 31), and 2-month follow-up
|
Positive and negative affect measured with the Positive and Negative Affect Schedule (PANAS).
20 items rated on a 5-point Likert scale.
Two subscales: Positive Affect (PA) and Negative Affect (NA).
Spanish validated version (Lopez-Gomez et al., 2015).
|
Baseline (Day 0), daily pre- and post-practice (Days 1-28), post-intervention (Day 31), and 2-month follow-up
|
|
Psychological Flexibility (MPFI-24)
時間枠：Baseline (Day 0), post-intervention (Day 31), and 2-month follow-up
|
Multidimensional psychological flexibility and inflexibility measured with the Multidimensional Psychological Flexibility Inventory short form (MPFI-24). 24 items rated on a 6-point Likert scale assessing 12 Hexaflex processes.
Spanish validated version (Navarrete et al., 2024).
|
Baseline (Day 0), post-intervention (Day 31), and 2-month follow-up
|
|
Psychological Flexibility (Psy-Flex)
時間枠：Baseline (Day 0), daily (Days 1-28), post-intervention (Day 31), and 2-month follow-up
|
Unified psychological flexibility measured with the Psy-Flex scale.
6 items rated on a 5-point Likert scale.
A modified daily version will be used during the intervention period.
Spanish validated version (Navarrete et al., 2024).
|
Baseline (Day 0), daily (Days 1-28), post-intervention (Day 31), and 2-month follow-up
|
|
Trait Anxiety (STAI-R)
時間枠：Baseline (Day 0), post-intervention (Day 31), and 2-month follow-up
|
Trait anxiety measured with the State-Trait Anxiety Inventory - Trait subscale (STAI-R).
20 items rated on a 4-point Likert scale (0-3).
Higher scores indicate greater trait anxiety.
Spanish validated version (Guillen-Riquelme & Buela-Casal, 2011).
|
Baseline (Day 0), post-intervention (Day 31), and 2-month follow-up
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Resting Heart Rate (RHR)
時間枠：Daily (Days 1-28)
|
Resting heart rate in beats per minute (bpm) obtained from participants' personal wearable devices (smartwatch/fitness tracker).
Change calculated as the slope of a linear regression fitted to daily values over the 28-day period.
|
Daily (Days 1-28)
|
|
Heart Rate Variability (HRV)
時間枠：Daily (Days 1-28)
|
Heart rate variability obtained from participants' personal wearable devices during deep sleep.
Change calculated as the slope of a linear regression fitted to daily values over the 28-day period.
Only available for participants with compatible devices.
|
Daily (Days 1-28)
|
|
Respiratory Rate (RR)
時間枠：Daily (Days 1-28)
|
Respiratory rate in breaths per minute obtained from participants' personal wearable devices.
Change calculated as the slope of a linear regression fitted to daily values over the 28-day period.
Only available for participants with compatible devices.
|
Daily (Days 1-28)
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- 主任研究者：Isaac Carmona-Rincón, PhD、Valencian International University (VIU)
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- Balban MY, Neri E, Kogon MM, Weed L, Nouriani B, Jo B, Holl G, Zeitzer JM, Spiegel D, Huberman AD. Brief structured respiration practices enhance mood and reduce physiological arousal. Cell Rep Med. 2023 Jan 17;4(1):100895. doi: 10.1016/j.xcrm.2022.100895. Epub 2023 Jan 10.
- Chan AW, Boutron I, Hopewell S, Moher D, Schulz KF, Collins GS, Tunn R, Aggarwal R, Berkwits M, Berlin JA, Bhandari N, Butcher NJ, Campbell MK, Chidebe RCW, Elbourne DR, Farmer AJ, Fergusson DA, Golub RM, Goodman SN, Hoffmann TC, Ioannidis JPA, Kahan BC, Knowles RL, Lamb SE, Lewis S, Loder E, Offringa M, Ravaud P, Richards DP, Rockhold FW, Schriger DL, Siegfried NL, Staniszewska S, Taylor RS, Thabane L, Torgerson DJ, Vohra S, White IR, Hrobjartsson A. SPIRIT 2025 statement: updated guideline for protocols of randomized trials. Nat Med. 2025 Jun;31(6):1784-1792. doi: 10.1038/s41591-025-03668-w. Epub 2025 Apr 29.
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2027年1月1日
一次修了 (推定)
2027年3月1日
研究の完了 (推定)
2027年5月1日
試験登録日
最初に提出
2026年5月27日
QC基準を満たした最初の提出物
2026年5月27日
最初の投稿 (実際)
2026年6月2日
学習記録の更新
投稿された最後の更新 (実際)
2026年6月4日
QC基準を満たした最後の更新が送信されました
2026年6月2日
最終確認日
2026年6月1日
詳しくは
本研究に関する用語
その他の研究ID番号
- VIU-BREATH-RCT-2026
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
はい
IPD プランの説明
Anonymized individual participant data (IPD) and the data dictionary will be made available upon reasonable request to the principal investigator (isaac.carmona@professor.universidadviu.com).
Requests will be evaluated on a case-by-case basis.
IPD 共有時間枠
Beginning 6 months after publication of primary results, available for 5 years
IPD 共有アクセス基準
Researchers who provide a methodologically sound proposal.
Data shared under a data sharing agreement ensuring confidentiality and appropriate use.
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
- ANALYTIC_CODE
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。