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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03312673
Other study ID # 69HCL17_0159
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 22, 2017
Est. completion date May 10, 2019

Study information

Verified date October 2019
Source Hospices Civils de Lyon
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The objective of the study is to determine whether poor control of asthma is related to an emotional deficit such as alexithymia. The hypothesis is that there is a correlation between the severity of asthma, its control, and the degree of emotional deficits.


Recruitment information / eligibility

Status Completed
Enrollment 70
Est. completion date May 10, 2019
Est. primary completion date May 10, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Men and women (> 18 years).

- Asthma (mild, moderate, severe).

- Beneficiary of social security

Exclusion Criteria:

- Pregnant women

- Patients who oppose their participation in the study

- Multiple drug users (psychoactive substances).

- Patients with severe psychiatric antecedents and comorbidities.

- Patients with cancer

- Patients with cognitive impairment

- Patients with speech, hearing, visual, and praxic disorders.

- Any chronic and especially respiratory pathology other than asthma (COPD, bronchiectasis), which can alter the study.

- Patients not speaking French

- Persons protected by law

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Interview and tests of drawing.
The intervention will take place with patients followed for asthma at the Croix Rousse hospital. Patients agreeing to participate in the study will come to the hospital for one hour and a half. They will answer questionnaires and tests of drawing. Results Restitution Session (optional) is proposed to patients within the next 4 weeks during a routine consultation.

Locations

Country Name City State
France Service de Pneumologie Hôpital de la Croix-Rousse Lyon

Sponsors (1)

Lead Sponsor Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Poor control of asthma The poor asthma control is defined by a score <20 on the ACT test During routine visit (one hour and a half)
Primary Emotional deficit such as alexithymia Defined by a score = 44 points/100 on the Toronto scale During routine visit (one hour and a half)
Primary Emotional deficit indicator traces Identifying indicator traces of emotional deficits according to the dimensions defining the alexithymia on the test of the tree and the drawing of the person During routine visit (one hour and a half)
Primary Depression Defined by a score = 11 points on the HADS scale During routine visit (one hour and a half)
Primary Anxiety Defined by a score = 11 points on the HADS scale During routine visit (one hour and a half)
Primary Emotional valences Defined by 8 scores distinct on Diener's subjective well-being scale During routine visit (one hour and a half)
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