Cystic FibrosisNCT06280066
An Intervention-Based Approach to Strengthen the Psychological Health of Children With Cystic Fibrosis and Their Mothers
A study testing Intervention Program Based on Strengthening the Psychological Resilience of Children Diagnosed with Cystic Fibrosis and Their Mothers in people with Cystic Fibrosis and Children, run by Kirsehir Ahi Evran Universitesi at 1 site in Turkey (Türkiye).
Trial summary
Cystic fibrosis (CF) is a life-threatening exocrine gland disease that is often diagnosed in childhood, and its incidence tends to increase and affect physical and mental health.The purpose of this study is to evaluate the effectiveness of the Intervention Program Based on Strengthening the Psychological Resilience of… Read more about this study
- Who is it for?
- Ages 8 to 12 years
- Conditions the study is for
- Cystic Fibrosis, Children, Resilience,Psychological
- What is being tested?
- Intervention Program Based on Strengthening the Psychological Resilience of Children Diagnosed with Cystic Fibrosis and Their Mothers
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Apr 2024to 30 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Being between the ages of 8-12,
- FEV 1 value, which is considered as the acceptance criterion in the terminal period in cystic fibrosis, is over 40%,
- Not having any physical or mental disability,
- Ability to communicate in Turkish,
- Not having an additional diagnosis such as type 1 diabetes or phenyl ketonuria,
- Volunteering to participate in the research.
Show all 10Show fewer
- Having a child diagnosed with CF between the ages of 8-12,
- Not having any physical or mental disability,
- Ability to communicate in Turkish,
- Volunteering to participate in the research.
Who cannot join
- Being on mechanical ventilation,
- Being in the preparation phase for lung transplantation
- Failure to fully participate in the Intervention Program Based on Strengthening the Psychological Resilience of Children Diagnosed with Cystic Fibrosis and Their Mothers.
- Lack of internet connection at home,
- Failure to fully participate in the Intervention Program Based on Strengthening the Psychological Resilience of Children Diagnosed with Cystic Fibrosis and Their Mothers.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Intervention-based Approach to Strengthen Life Skills and Psychological Resilience of Children With Cystic Fibrosis and Their Mothers
Cystic fibrosis (CF) is a life-threatening exocrine gland disease that is often diagnosed in childhood, and its incidence tends to increase and affect physical and mental health.The purpose of this study is to evaluate the effectiveness of the Intervention Program Based on Strengthening the Psychological Resilience of Children Diagnosed with Cystic Fibrosis and Their Mothers, prepared for children with CF (8-12 years old) and their mothers. The study is conducted in two phases using an advanced mixed-methods intervention design. In the first stage, the CF experiences of children with cystic fibrosis and how they perceive these experiences will be examined with visual phenomenology, and their mothers' CF experiences and perceptions will be examined with phenomenology. In this regard, 10 children will be asked to draw pictures and their pictures will be analyzed. In-depth individual interviews will be held with mothers.In the 2nd stage, the effectiveness of the Intervention Program Based on Strengthening Psychological Resilience for Children Diagnosed with Cystic Fibrosis and Their Mothers will be determined with a pre-test-post-test randomized controlled experimental design.In the literature review, Gpower analysis was performed (α: 0.05, β: 0.99, d: 1.88) based on the results of studies conducted with children diagnosed with CF and their parents, similar to this study, and 15 samples were used for each group. It is planned to recruit people. Considering the possibility of data loss in the study, it was always deemed appropriate to include 22 people for the group. It was planned to sample a total of 88 children with CF and their mothers, 44 in the intervention group and 44 in the control group. In the 3rd stage, after the experiment, the participants' experiences regarding the intervention program will be examined through interviews and qualitative research method. Thus, qualitative interviews will be conducted before and after the experiment. Data will be collected using these tools: Children; Child and Mother Descriptive Characteristics Form, Semi-Structured Interview Form,Respiratory Function Test, Reorganized Cystic Fibrosis Questionnaire, Psychological Resilience Attitude and Skills Scale and Functional Disability Inventory; Mothers; The Revised Cystic Fibrosis Questionnaire, The Depression Anxiety and Stress Scale, Post-Traumatic Growth Scale and Brief Psychological Resilience Scale. Measurements will be taken before the intervention, after the intervention, at the 1st and 3rd months.
Read the detailed description
Cystic fibrosis (CF) is a life-threatening exocrine gland disease that is often diagnosed in childhood and its incidence tends to increase. CF affects many systems, especially the respiratory and gastrointestinal systems, and is life-threatening with its progressive course. In addition to the complications that arise due to the disease affecting many systems, the limited life expectancy and poor prognosis also bring psychological and social problems for children and their families. Especially if it is a genetically inherited disease, it may cause the parent to blame himself or herself and experience psychological problems. It is stated that in order to make it easier for children with CF and their families to cope with the negativities brought about by the disease, their psychological resilience levels should be strengthened and health professionals should encourage families to do so. Apart from increasing the level of psychological resilience, other methods that contribute to the reduction of psychological problems include yoga, meditation and laughter yoga. Laughter yoga is a series of exercises that combine gratuitous laughter with yoga breathing techniques, as well as stretching-relaxation techniques, laughter and deep breathing exercises. It is reported that laughter yoga physiologically increases breathing in the body, relaxes muscles, strengthens mental function by reducing the level of stress hormones, reduces burnout, depression and anxiety levels, positively affects the quality of life and increases psychological well-being. In this context, an intervention program was created for children with CF and their mothers, including psychological resilience training, laughter yoga, concentrated breathing exercise and meditation.
- Conditions
- Cystic Fibrosis, Children, Resilience,Psychological, Laughter Yoga, Laughter Therapy, Mothers
- Being tested
- Intervention Program Based on Strengthening the Psychological Resilience of Children Diagnosed with Cystic Fibrosis and Their Mothers
- Keywords
- cystic fibrosis, children, psychological resilience, laughter yoga, laughter therapy, mothers, psychological health, lung functions
- Medical subject headings
- Cystic Fibrosis, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention Program Based on Strengthening the Psychological Resilience of Children Diagnosed with Cystic Fibrosis and Their MothersOther
The content of the Intervention Program Based on Strengthening the Psychological Resilience of Children Diagnosed with Cystic Fibrosis and Their Mothers will include the Psychological Resiliency Program for Children and Adolescents developed by Akar (2018), laughter yoga, meditation, breathing exercises and therapeutic story sessions.
| Study group | Role | What they receive |
|---|---|---|
| Children Intervention Group | Experimental | Intervention Program Based on Strengthening Psychological Resilience for Children with Cystic Fibrosis and Their Mothers. The program will be implemented for 10 weeks, with a total of 10 sessions, 1 session per week (each session consists of 2 sessions). Receives: Other: Intervention Program Based on Strengthening the Psychological Resilience of Children Diagnosed with Cystic Fibrosis and Their Mothers |
| Mothers Intervention Group | Experimental | Intervention Program Based on Strengthening Psychological Resilience for Children with Cystic Fibrosis and Their Mothers. The program will be implemented for 10 weeks, with a total of 10 sessions, 1 session per week (each session consists of 2 sessions). Receives: Other: Intervention Program Based on Strengthening the Psychological Resilience of Children Diagnosed with Cystic Fibrosis and Their Mothers |
| Children Controlled Group | No intervention | No intervention. |
| Mothers Controlled Group | No intervention | No intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Respiratory Function Test
Children will have a respiratory function test performed at the center where the research will be conducted. As a result of the rest, the children's FEV1 and FVC values will be examined.
Measured: The measurement will start two weeks before the intervention, immediately after the intervention.
The Revised Cystic Fibrosis Questionnaire Child Form
The scale that evaluates the quality of life due to the impact of cystic fibrosis-specific health status is a 4-point Likert type. A higher score indicates a better CF-specific health-related quality of life.
Measured: The measurement will start two weeks before the intervention, immediately after the intervention, and 1 and 3 months after the intervention.
Psychological Resilience Attitude and Skills Scale Child Form
Scores range from 34 to 136 on the scale, and as the score increases, the level of psychological resilience of children increases.
Measured: The measurement will start two weeks before the intervention, immediately after the intervention, and 1 and 3 months after the intervention.
Functional Disability Inventory Child
It is a child self-report tool that evaluates the impact of the disease on physical and psychosocial functioning in daily social roles and daily activities at home and at school. The scale is a 5-point Likert type. The minimum score that can be obtained from the scale is 0, and the maximum score is 60. As the score obtained from the scale increases, the level of disability increases.
Measured: The measurement will start two weeks before the intervention, immediately after the intervention, and 1 and 3 months after the intervention.
The Revised Cystic Fibrosis Questionnaire Parent Form
The CFQ-R Parent version is a self-report instrument consisting of 44 items grouped into 11 domains assessing physical functioning, emotional functioning, vitality, school performance, eating disorders, weight, body image, treatment burden, health perceptions, and respiratory and digestive symptoms. A higher score on the CFQ-R Parent version indicates a better CF-specific health-related quality of life.The total point range is 0-100, with higher scores indicating better CF-specific health-related quality of life.
Measured: The measurement will start two weeks before the intervention, immediately after the intervention, and 1 and 3 months after the intervention.
Depression Anxiety and Stress Scale
It will be used to determine mothers' depression, anxiety, and stress levels. The scale is a 4-point Likert type and consists of 3 subscales (depression, anxiety, and stress) and 21 questions. The minimum score that can be obtained from the scale is 0, and the maximum score is 21. A high score on the sub-dimension of the scale indicates that the level of that sub-dimension is high.
Measured: The measurement will start two weeks before the intervention, immediately after the intervention, and 1 and 3 months after the intervention.
Post-Traumatic Growth Scale
As the score obtained from this scale, which will be used to determine the post-traumatic growth levels of mothers, increases, the post-traumatic growth level also increases.The scale is a 6-point Likert-type scale, consisting of 5 sub-dimensions and a total of 21 items. The minimum score that can be obtained from the scale is 0, and the maximum score is 105. As the score increases, the level of post-traumatic growth also increases.
Measured: The measurement will start two weeks before the intervention, immediately after the intervention, and 1 and 3 months after the intervention.
Brief Psychological Resilience Scale
A minimum of 6 and a maximum of 30 points can be obtained from this scale, which will be used to determine the psychological resilience levels of mothers, and higher scores indicate higher psychological resilience.
Measured: The measurement will start two weeks before the intervention, immediately after the intervention, and 1 and 3 months after the intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2024
- Study start2 Apr 2024
- Primary completion2 Jun 2024
- Study completion30 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- More trials run by Kirsehir Ahi Evran UniversitesiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Advanced mixed-methods intervention design.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kirsehir Ahi Evran Universitesi
- Sponsor type
- University, hospital or other
- Collaborators
- TC Erciyes University
- Responsible party
- Principal investigator, Selin Soyunmez, Kirsehir Ahi Evran Universitesi
- Investigators
- Yağmur Sezer Efe, Principal investigator, TC Erciyes UniversitySelin Söyünmez, Principal investigator, TC Erciyes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06280066
- Sponsor's protocol ID
- 2023/607
- Status last verified
- Aug 2024
- First submitted
- 5 Jan 2024
- Last updated
- 15 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Intervention-based Approach to Strengthen Life Skills and Psychological Resilience of Children With Cystic Fibrosis and Their Mothers
- ClinicalTrials.gov ID
- NCT06280066
- Acronym / sponsor ID
- 2023/607
- Conditions
- Cystic Fibrosis, Children, Resilience,Psychological, Laughter Yoga, Laughter Therapy, Mothers
- Keywords
- cystic fibrosis, children, psychological resilience, laughter yoga, laughter therapy, mothers, psychological health, lung functions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Kirsehir Ahi Evran UniversitesiUniversity, hospital or other
- Collaborators
- TC Erciyes University
- Study start
- 2 Apr 2024 (actual)
- Primary completion
- 2 Jun 2024 (actual)
- Study completion
- 30 Jul 2025 (actual)
- First posted
- 28 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Cystic fibrosis (CF) is a life-threatening exocrine gland disease that is often diagnosed in childhood, and its incidence tends to increase and affect physical and mental health.The purpose of this study is to evaluate the effectiveness of the Intervention Program Based on Strengthening the Psychological Resilience of Children Diagnosed with Cystic Fibrosis and Their Mothers, prepared for children with CF (8-12 years old) and their mothers. The study is conducted in two phases using an advanced mixed-methods intervention design. In the first stage, the CF experiences of children with cystic fibrosis and how they perceive these experiences will be examined with visual phenomenology, and their mothers' CF experiences and perceptions will be examined with phenomenology. In this regard, 10 children will be asked to draw pictures and their pictures will be analyzed. In-depth individual interviews will be held with mothers.In the 2nd stage, the effectiveness of the Intervention Program Based on Strengthening Psychological Resilience for Children Diagnosed with Cystic Fibrosis and Their Mothers will be determined with a pre-test-post-test randomized controlled experimental design.In the literature review, Gpower analysis was performed (α: 0.05, β: 0.99, d: 1.88) based on the results of studies conducted with children diagnosed with CF and their parents, similar to this study, and 15 samples were used for each group. It is planned to recruit people. Considering the possibility of data loss in the study, it was always deemed appropriate to include 22 people for the group. It was planned to sample a total of 88 children with CF and their mothers, 44 in the intervention group and 44 in the control group. In the 3rd stage, after the experiment, the participants' experiences regarding the intervention program will be examined through interviews and qualitative research method. Thus, qualitative interviews will be conducted before and after the experiment. Data will be collected using these tools: Children; Child and Mother Descriptive Characteristics Form, Semi-Structured Interview Form,Respiratory Function Test, Reorganized Cystic Fibrosis Questionnaire, Psychological Resilience Attitude and Skills Scale and Functional Disability Inventory; Mothers; The Revised Cystic Fibrosis Questionnaire, The Depression Anxiety and Stress Scale, Post-Traumatic Growth Scale and Brief Psychological Resilience Scale. Measurements will be taken before the intervention, after the intervention, at the 1st and 3rd months.
Detailed description
Cystic fibrosis (CF) is a life-threatening exocrine gland disease that is often diagnosed in childhood and its incidence tends to increase. CF affects many systems, especially the respiratory and gastrointestinal systems, and is life-threatening with its progressive course. In addition to the complications that arise due to the disease affecting many systems, the limited life expectancy and poor prognosis also bring psychological and social problems for children and their families. Especially if it is a genetically inherited disease, it may cause the parent to blame himself or herself and experience psychological problems. It is stated that in order to make it easier for children with CF and their families to cope with the negativities brought about by the disease, their psychological resilience levels should be strengthened and health professionals should encourage families to do so. Apart from increasing the level of psychological resilience, other methods that contribute to the reduction of psychological problems include yoga, meditation and laughter yoga. Laughter yoga is a series of exercises that combine gratuitous laughter with yoga breathing techniques, as well as stretching-relaxation techniques, laughter and deep breathing exercises. It is reported that laughter yoga physiologically increases breathing in the body, relaxes muscles, strengthens mental function by reducing the level of stress hormones, reduces burnout, depression and anxiety levels, positively affects the quality of life and increases psychological well-being. In this context, an intervention program was created for children with CF and their mothers, including psychological resilience training, laughter yoga, concentrated breathing exercise and meditation.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
- Model description
- Advanced mixed-methods intervention design.
| Arm | Type | Receives |
|---|---|---|
| Children Intervention Group | Experimental | Other: Intervention Program Based on Strengthening the Psychological Resilience of Children Diagnosed with Cystic Fibrosis and Their MothersIntervention Program Based on Strengthening Psychological Resilience for Children with Cystic Fibrosis and Their Mothers. The program will be implemented for 10 weeks, with a total of 10 sessions, 1 session per week (each session consists of 2 sessions). |
| Mothers Intervention Group | Experimental | Other: Intervention Program Based on Strengthening the Psychological Resilience of Children Diagnosed with Cystic Fibrosis and Their MothersIntervention Program Based on Strengthening Psychological Resilience for Children with Cystic Fibrosis and Their Mothers. The program will be implemented for 10 weeks, with a total of 10 sessions, 1 session per week (each session consists of 2 sessions). |
| Children Controlled Group | No intervention | –No intervention. |
| Mothers Controlled Group | No intervention | –No intervention. |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- Being between the ages of 8-12,
- FEV 1 value, which is considered as the acceptance criterion in the terminal period in cystic fibrosis, is over 40%,
- Not having any physical or mental disability,
- Ability to communicate in Turkish,
- Not having an additional diagnosis such as type 1 diabetes or phenyl ketonuria,
Key exclusion criteria (5 listed)
- Being on mechanical ventilation,
- Being in the preparation phase for lung transplantation
- Failure to fully participate in the Intervention Program Based on Strengthening the Psychological Resilience of Children Diagnosed with Cystic Fibrosis and Their Mothers.
- Lack of internet connection at home,
- Failure to fully participate in the Intervention Program Based on Strengthening the Psychological Resilience of Children Diagnosed with Cystic Fibrosis and Their Mothers.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intervention Program Based on Strengthening the Psychological Resilience of Children Diagnosed with Cystic Fibrosis and Their MothersThe content of the Intervention Program Based on Strengthening the Psychological Resilience of Children Diagnosed with Cystic Fibrosis and Their Mothers will include the Psychological Resiliency Program for Children and Adolescents developed by Akar (2018), laughter yoga, meditation, breathing exercises and therapeutic story sessions. | Other | Children Intervention Group, Mothers Intervention Group |
Primary outcome
The Respiratory Function Test
Time frame: The measurement will start two weeks before the intervention, immediately after the intervention.
Children will have a respiratory function test performed at the center where the research will be conducted. As a result of the rest, the children's FEV1 and FVC values will be examined.
The Revised Cystic Fibrosis Questionnaire Child Form
Time frame: The measurement will start two weeks before the intervention, immediately after the intervention, and 1 and 3 months after the intervention.
The scale that evaluates the quality of life due to the impact of cystic fibrosis-specific health status is a 4-point Likert type. A higher score indicates a better CF-specific health-related quality of life.
Psychological Resilience Attitude and Skills Scale Child Form
Time frame: The measurement will start two weeks before the intervention, immediately after the intervention, and 1 and 3 months after the intervention.
Scores range from 34 to 136 on the scale, and as the score increases, the level of psychological resilience of children increases.
Functional Disability Inventory Child
Time frame: The measurement will start two weeks before the intervention, immediately after the intervention, and 1 and 3 months after the intervention.
It is a child self-report tool that evaluates the impact of the disease on physical and psychosocial functioning in daily social roles and daily activities at home and at school. The scale is a 5-point Likert type. The minimum score that can be obtained from the scale is 0, and the maximum score is 60. As the score obtained from the scale increases, the level of disability increases.
The Revised Cystic Fibrosis Questionnaire Parent Form
Time frame: The measurement will start two weeks before the intervention, immediately after the intervention, and 1 and 3 months after the intervention.
The CFQ-R Parent version is a self-report instrument consisting of 44 items grouped into 11 domains assessing physical functioning, emotional functioning, vitality, school performance, eating disorders, weight, body image, treatment burden, health perceptions, and respiratory and digestive symptoms. A higher score on the CFQ-R Parent version indicates a better CF-specific health-related quality of life.The total point range is 0-100, with higher scores indicating better CF-specific health-related quality of life.
Depression Anxiety and Stress Scale
Time frame: The measurement will start two weeks before the intervention, immediately after the intervention, and 1 and 3 months after the intervention.
It will be used to determine mothers' depression, anxiety, and stress levels. The scale is a 4-point Likert type and consists of 3 subscales (depression, anxiety, and stress) and 21 questions. The minimum score that can be obtained from the scale is 0, and the maximum score is 21. A high score on the sub-dimension of the scale indicates that the level of that sub-dimension is high.
Post-Traumatic Growth Scale
Time frame: The measurement will start two weeks before the intervention, immediately after the intervention, and 1 and 3 months after the intervention.
As the score obtained from this scale, which will be used to determine the post-traumatic growth levels of mothers, increases, the post-traumatic growth level also increases.The scale is a 6-point Likert-type scale, consisting of 5 sub-dimensions and a total of 21 items. The minimum score that can be obtained from the scale is 0, and the maximum score is 105. As the score increases, the level of post-traumatic growth also increases.
Brief Psychological Resilience Scale
Time frame: The measurement will start two weeks before the intervention, immediately after the intervention, and 1 and 3 months after the intervention.
A minimum of 6 and a maximum of 30 points can be obtained from this scale, which will be used to determine the psychological resilience levels of mothers, and higher scores indicate higher psychological resilience.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yağmur Sezer Efe principal investigator
TC Erciyes University
Selin Söyünmez principal investigator
TC Erciyes University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention Program Based on Strengthening the Psychological Resilience of Children Diagnosed with Cystic Fibrosis and Their Mothers in people with Cystic Fibrosis and Children, run by Kirsehir Ahi Evran Universitesi at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Respiratory Function Test (time frame: The measurement will start two weeks before the intervention, immediately after the intervention.). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2026.