NCT05793866

Brief Summary

In this study, the effect of buteyko breathing technique applied in children aged 7-12 years with asthma disease on asthma control and quality of life is examined. Asthma is a serious global health problem affecting all age groups. In studies conducted with the ISSAC (International study of asthma and allergies in childhood) method, the prevalence of asthma varies between 4-23% in developed populations. In childhood prevalence studies in our country, the cumulative asthma prevalence was found to be between 13.7% and 15.3%. There are personal and environmental factors of genetic origin that cause asthma. Its prevalence is increasing in many countries, particularly among children. Asthma is a chronic inflammatory disease of the airways in which many cells and cellular elements play a role. It is seen with recurrent episodes of wheezing, coughing and shortness of breath due to lower airway obstruction and chronic inflammation. Nurses will contribute to the protection and improvement of patients' health and well-being, to control asthma, to increase the quality of life, and to reduce health care expenditures, thanks to the hands-on training they will give to patients with asthma. Keyword: Asthma, Quality of Life, Asthma Control

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2023

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 3, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 31, 2023

Completed
7 months until next milestone

Study Start

First participant enrolled

October 15, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2024

Completed
Last Updated

January 22, 2025

Status Verified

January 1, 2025

Enrollment Period

5 months

First QC Date

February 3, 2023

Last Update Submit

January 20, 2025

Conditions

Keywords

AsthmaQuality of LifeAsthma Control

Outcome Measures

Primary Outcomes (1)

  • Asthma Control Test for Children (CISAT)

    Asthma control test is the most used test today, is easily understood by patients and their families, and is an important test that shows whether asthma is good or bad. AKT is a questionnaire consisting of 5 questions. It is a 5-item asthma control questionnaire that defines children whose asthma is not adequately controlled. The ACT is scored on a scale of 1-5 for each question. Patients rate each question between one and five points. The total score of the five questions forms the test result. If the total score is 25, it is considered as full control, 24-20 as partial control, and ≤19 as not under control

    at the end of 4 weeks

Secondary Outcomes (1)

  • The Scale of Quality of Life in Children with Asthma ÇAYKÖ

    at the end of 4 weeks

Study Arms (2)

BUTEYKO RESPIRATORY TECHNIQUE APPLIED GROUP

EXPERIMENTAL

This group consists of children between the ages of 7 and 12 who are being treated for asthma. Children with written and verbal consent from their families will be filled with a personal information form, asthma control test and quality of life scale for children. The standard care and treatment of the asthmatic child included in the experimental group will be continued without any intervention. The child included in this group will be taught the Buteyko Breathing Technique (BST) via a smart phone, and the training video will be watched and taught. The training video will be watched on the official site that explains BST in a practical way. The video will be downloaded to the phone of the child or parent using a smartphone at home, for researchers to apply later at home. The participant will continue to apply this technique at home for 10 minutes in addition to his treatment when he needs a bronchodilator in the morning and evening for 4 weeks.

Behavioral: BUTEYKO RESPIRATORY TECHNIQUE

GROUP WITH STANDARD CARE AND TREATMENT

NO INTERVENTION

This group consists of children aged 7-12 years with asthma who continue to receive standard care and treatment. Children with written and verbal consent from their families will be filled with a personal information form, asthma control test and quality of life scale for children. Asthma control test and quality of life scale for the child with asthma will be administered to the participant who continues the standard treatment and care for 4 weeks. After the research data are collected, the children in the control group will be shown a video explaining the BST in a practical way.

Interventions

Buteyko Breathing Technique In recent years, breathing exercises have been used as one of the non-pharmacological, alternative and/or complementary approaches in the management of many chronic diseases and conditions. Buteyko Breathing Technique (BST), Russian Dr. It was developed by Konstantin Buteyko in the 1950s. Dr. Buteyko evaluates the normal respiration over carbon dioxide, the respiratory holding time used in the technique is defined as a control pause, and this value shows the body's oxygenation and carbon dioxide tolerance. BST is a technique performed only through the nose, which includes respiratory control and respiratory hold after inhalation.

BUTEYKO RESPIRATORY TECHNIQUE APPLIED GROUP

Eligibility Criteria

Age7 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • with asthma,
  • years old with asthma
  • Those who were diagnosed with asthma at least 6 months ago were treated

You may not qualify if:

  • No asthma,
  • Those over 12 years old and under 7 years old with asthma
  • Any disease that will prevent or prevent the practice of breathing technique

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Balcali Hospital Adana

Adana, Turkey (Türkiye)

Location

Çukurova Üniversitesi Balcalı Hastanesi

Adana, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 3, 2023

First Posted

March 31, 2023

Study Start

October 15, 2023

Primary Completion

March 15, 2024

Study Completion

September 15, 2024

Last Updated

January 22, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations