Cystic FibrosisDoulAnxMucoNCT05948488
Psychological Study in Children With Mucoviscidosis
An observational study of Cystic Fibrosis, run by University Hospital, Toulouse at 1 site in France.
Trial summary
Cystic fibrosis is the most common serious genetic disease in Europe. It is a multi-disciplinary disease, causing multiple organ damage. It is a painful disease and a source of anxiety and depression. Read more about this study
- Who is it for?
- Ages 8 to 17 years
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- Questionnaires
- How many people
- 160 participants
- Where
- 1 siteFrance
- Study dates
- 28 Feb 2019to 28 Aug 2022
- Phase
- Observational
- 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 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Children over 8 and under 18 with cystic fibrosis. Children must be represented by their parent.
Who may be able to join
- Have cystic fibrosis
- Child aged over 8 years and under 18 years
- Presence of at least one parent at the time of inclusion
- To be present for a scheduled hospitalisation at the Resources and Competence Centres for Cystic Fibrosis
- Do not object to the research
Who cannot join
- Under 8 or over 18 years of age
- Lack of at least one parent at the time of inclusion
- Presence of chronic co-morbidities
- Difficulty reading and understanding French
- Objection to taking part in research
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Psychological Study of the Links Between Feeling and Fear of Pain, Anxiety and Quality of Life in Children With Mucoviscidosis
Cystic fibrosis is the most common serious genetic disease in Europe. It is a multi-disciplinary disease, causing multiple organ damage. It is a painful disease and a source of anxiety and depression.
The aim of this study is to assess the link between pain experienced during care and anxiety in children aged over 8 with cystic fibrosis.
- Conditions
- Cystic Fibrosis
- Being tested
- Questionnaires
- Keywords
- Cystic Fibrosis, Children, Pain, Anxiety
- Medical subject headings
- Cystic Fibrosis, Pain, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnairesOther
The questionnaires focus on anxiety, fear and quality of life.
| Study group | Role | What they receive |
|---|---|---|
| Children with cystic fibrosis | Children over 8 and under 18 with cystic fibrosis. Children must be represented by their parent. Receives: Other: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Links between pain during care and anxiety
Pain during care is assessed using the Visual Analogic Scale (VAS) and anxiety using the State Trait Anxiety Inventory (STAI) scale.
The Visual Analogic Scale (VAS) is a self-assessment scale. It is a line. At one end is indicated: 0 "no pain", at the other: 100 "unbearable pain".
The State Trait Anxiety Inventory (STAI) is a self-assessment scale. It consists of 20 items. For item, the child has to choose one of three modalities : almost never, sometimes, often. The higher the score, the more severe the anxiety.
Measured: 1 day
Secondary outcomes (5)
Links between pain-related fears and pain during care
Pain related fears is assessed using the Fear of Pain Questionnaire (FOPQ) and pain during care using the Visual Analogic Scale (VAS).
The Fear of Pain Questionnaire (FOPQ) is a self-assessment scale. It consists of 24 items. For item, there are five modalities : strongly disagree, disagree, don't know, agree, strongly agree.
The Visual Analogic Scale (VAS) is a self-assessment scale. It takes the form of a line. At one end is indicated: 0 "no pain", at the other: 100 "unbearable pain".
Measured: 1 day
Links between pain during care and quality of life
Pain during care is assessed using the Visual Analogic Scale (VAS) and quality of life using the Cystic Fibrosis Questionnaire (CFQ).
The Visual Analogic Scale (VAS) is a self-assessment scale. It is a line. At one end is indicated: 0 "no pain", at the other: 100 "unbearable pain".
The Cystic Fibrosis Questionnaire (CFQ) composed of four modalities : always, often, sometime, never.
Measured: 1 day
Links between pain during care and the severity of the disease
Pain during care is assessed using the Visual Analogic Scale (VAS) and the severity of the disease by the number of respiratory exacerbations per year.
The Visual Analogic Scale (VAS) is a self-assessment scale. It is a line. At one end is indicated: 0 "no pain", at the other: 100 "unbearable pain".
Measured: 1 day
Links between the severity of the disease and anxiety
Anxiety is assessed using tthe State Trait Anxiety Inventory (STAI) scale and the severity of the disease by the number of respiratory exacerbations per year.
The State Trait Anxiety Inventory (STAI) is a self-assessment scale. It consists of 20 items. For item, the child has to choose one of three modalities : almost never, sometimes, often. The higher the score, the more severe the anxiety.
Measured: 1 day
Links between parents' anxiety and the child's anxiety
Parent's anxiety and child's anxiety is assessed using tthe State Trait Anxiety Inventory (STAI) scale.
The State Trait Anxiety Inventory (STAI) is a self-assessment scale. It consists of 20 items. For item, the child has to choose one of three modalities : almost never, sometimes, often. The higher the score, the more severe the anxiety.
The scale is suitable for parents and children.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2023
- Study start28 Feb 2019
- Primary completion28 Aug 2022
- Study completion28 Aug 2022
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 University Hospital, ToulouseThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Géraldine LABOURET, MD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05948488
- Sponsor's protocol ID
- RC31/18/0304
- Other IDs
- 2018-A02216-49
- Acronym
- DoulAnxMuco
- Status last verified
- Jul 2023
- First submitted
- 5 Jul 2023
- Last updated
- 17 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychological Study of the Links Between Feeling and Fear of Pain, Anxiety and Quality of Life in Children With Mucoviscidosis
- ClinicalTrials.gov ID
- NCT05948488
- Acronym / sponsor ID
- DoulAnxMuco / RC31/18/0304
- Conditions
- Cystic Fibrosis
- Keywords
- Cystic Fibrosis, Children, Pain, Anxiety
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 28 Feb 2019 (actual)
- Primary completion
- 28 Aug 2022 (actual)
- Study completion
- 28 Aug 2022 (actual)
- First posted
- 17 Jul 2023 (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 is the most common serious genetic disease in Europe. It is a multi-disciplinary disease, causing multiple organ damage. It is a painful disease and a source of anxiety and depression.
The aim of this study is to assess the link between pain experienced during care and anxiety in children aged over 8 with cystic fibrosis.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children with cystic fibrosis | – | Other: QuestionnairesChildren over 8 and under 18 with cystic fibrosis. Children must be represented by their parent. |
Who may qualify
- Ages
- 8 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children over 8 and under 18 with cystic fibrosis. Children must be represented by their parent.
Key inclusion criteria (5 listed)
- Have cystic fibrosis
- Child aged over 8 years and under 18 years
- Presence of at least one parent at the time of inclusion
- To be present for a scheduled hospitalisation at the Resources and Competence Centres for Cystic Fibrosis
- Do not object to the research
Key exclusion criteria (5 listed)
- Under 8 or over 18 years of age
- Lack of at least one parent at the time of inclusion
- Presence of chronic co-morbidities
- Difficulty reading and understanding French
- Objection to taking part in research
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 |
|---|---|---|
| QuestionnairesThe questionnaires focus on anxiety, fear and quality of life. | Other | Children with cystic fibrosis |
Primary outcome
Links between pain during care and anxiety
Time frame: 1 day
Pain during care is assessed using the Visual Analogic Scale (VAS) and anxiety using the State Trait Anxiety Inventory (STAI) scale. The Visual Analogic Scale (VAS) is a self-assessment scale. It is a line. At one end is indicated: 0 "no pain", at the other: 100 "unbearable pain". The State Trait Anxiety Inventory (STAI) is a self-assessment scale. It consists of 20 items. For item, the child has to choose one of three modalities : almost never, sometimes, often. The higher the score, the more severe the anxiety.
5 secondary outcomes
Links between pain-related fears and pain during care
Time frame: 1 day
Links between pain during care and quality of life
Time frame: 1 day
Links between pain during care and the severity of the disease
Time frame: 1 day
Links between the severity of the disease and anxiety
Time frame: 1 day
Links between parents' anxiety and the child's anxiety
Time frame: 1 day
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 17 Jul 2023.
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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.
Géraldine LABOURET, MD principal investigator
University Hospital, Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cystic Fibrosis, run by University Hospital, Toulouse at 1 site in France.
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 5 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 17 Jul 2023. 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 France. 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?
Links between pain during care and anxiety (time frame: 1 day). 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 17 Jul 2023.