Psychological Study in Children With Mucoviscidosis (DoulAnxMuco)

July 5, 2023 updated by: University Hospital, Toulouse

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
160

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Toulouse, France
        • Géraldine LABOURET

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Children over 8 and under 18 with cystic fibrosis. Children must be represented by their parent.

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Children with cystic fibrosis
Children over 8 and under 18 with cystic fibrosis. Children must be represented by their parent.
Other: Questionnaires
The questionnaires focus on anxiety, fear and quality of life.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
1 day

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Links between pain-related fears and pain during care
Time Frame: 1 day

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".
1 day
Links between pain during care and quality of life
Time Frame: 1 day

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.
1 day
Links between pain during care and the severity of the disease
Time Frame: 1 day

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".
1 day
Links between the severity of the disease and anxiety
Time Frame: 1 day

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.
1 day
Links between parents' anxiety and the child's anxiety
Time Frame: 1 day

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.
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Toulouse

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Géraldine LABOURET, MD, University Hospital, Toulouse

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 28, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 28, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 28, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 5, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 5, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 17, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 17, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 5, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RC31/18/0304
  • 2018-A02216-49 (Other Identifier: ID-RCB)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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