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Efficacy of the Combination of Mindfulness and Buteyko Techniques for the Improvement of Poorly Controlled Asthma.

NCT ID: NCT05593315

Last Updated: 2023-03-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-01

Study Completion Date

2025-12-31

Brief Summary

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Administration of a combined program for general (Mindfulness) and respiratory (Buteyko technique) relationship in patients with poorly controlled asthma and anxiety/stress to determine if it provides an improvement in current control and future risk of asthma.

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Detailed Description

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A Mindfulness relaxation program and a Buteyko technique respiratory rehabilitation program will be administered individually and weekly, in 10 sessions (5 face-to-face and 5 telematic sessions afterwards). Patients will be visited 4 times (at inclusion, one month, 6 months and 12 months after the double intervention), where data on asthmatic morbidity, pulmonary function (spirometry), bronchial inflammation (FENO) will be collected and some questionnaires will be administered.

Conditions

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Asthma Anxiety Stress

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

A Mindfulness relaxation program and a Buteyko technique respiratory rehabilitation program will be administered individually and weekly, in 10 sessions (5 face-to-face and 5 telematic sessions afterwards).
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Mindfulness and Buteyko techniques

A Mindfulness relaxation program and a Buteyko technique respiratory rehabilitation program will be administered individually and weekly, in 10 sessions (5 face-to-face and 5 telematic sessions afterwards).

Group Type OTHER

Mindfulness and Buteyko techniques

Intervention Type OTHER

Joint implementation of a general relaxation program and a respiratory rehabilitation program in patients with poorly controlled asthma.

Interventions

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Mindfulness and Buteyko techniques

Joint implementation of a general relaxation program and a respiratory rehabilitation program in patients with poorly controlled asthma.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of poorly controlled asthma
* In treatment with a combination of ICS/LABA at medium doses
* Anxiety and/or functional dyspnea
* Attended in the outpatient consultations of the Asthma Unit of the Pneumology and Allergy Service of the Hospital de la Santa Creu i Sant Pau in Barcelona

Exclusion Criteria

* Severe asthma exacerbation in the last 30 days
* Severe disabling comorbidity
* Severe psychiatric illness
* Inability to complete questionnaires.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hospital de la Santa Creu i Sant Pau. Carrer Mas Casanovas 90.

Barcelona, , Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Vicente Plaza Moral, PhD

Role: CONTACT

[email protected]
+34 93 556 56 01 ext. 5971

Facility Contacts

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Vicente Plaza, MD

Role: primary

[email protected]
+34-935565972

References

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Other Identifiers

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IIBSP-MBA-2022-95

Identifier Type: -

Identifier Source: org_study_id

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