- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04316533
Work Stress and Impact of Pruritus on Quality of Life (PRUERI)
Study of the Association Between Work Stress and the Impact of Pruritus on Quality of Life
Study Overview
Status
Conditions
Detailed Description
Background. Stress increases the likelihood of psoriasis flare-up episodes and itching. Few studies have focused on work-related stress on such skin symptoms.
Objective. To study the association between work-related stress, pruritus and quality of life among workers suffering from psoriasis.
Methods. Investigators will conduct a monocentric non-interventional prospective study. Patients suffering from psoriasis will be recruited in both the Dermatology inpatient ward and outpatient clinic of Brest University Hospital . Included patients will be workers. Work-related stress will be assessed using the Effort-Reward Imbalance (ERI) model. The impact of pruritus on quality of life will be assessed with the Itchy Quality of Life (ItchyQoL) self-administered questionnaire. The collected data will include age, sex, body mass index, ordered medication to treat psoriasis, weekly working hours. The association between ERI and ItchyQoL scores will be studied using a univariate logistic regression.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Finistère
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Brest, Finistère, France, 29609
- Chru Brest
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Major patients
- Active busy patients with psoriasis presenting for a dermatology consultation or hospitalization at the Brest CHRU
- Participation agreement
Exclusion Criteria:
- Presence of another potentially pruritic pathology
- No command of the French language
- Patient under legal protection (guardianship, curatorship, etc.)
- Refusal to participate
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pruritus' impact on quality of life
Time Frame: time required to complete the self questionnaire estimated at approximately 5 min immediately after consultation with the dermatologist
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The Itchy Quality of Life questionnaire (ItchyQoL) assess the quality of life linked to pruritus.
It is a 22-item questionnaire wich assess the frequency of pruritus'symptoms in the past seven days.
The score is between 22 and 110.
The higher the score, the greater the impact of pruritus.
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time required to complete the self questionnaire estimated at approximately 5 min immediately after consultation with the dermatologist
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Occupational stress
Time Frame: time required to complete the self questionnaire estimated at approximately 5 min immediately after consultation with the dermatologist
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The effort-reward imbalance questionnaire in 23-item for occupational stress.
Six items make it possible to calculate the extrinsic efforts felt (score e) and eleven items assess the rewards perceived by the employee (score r).
The ERI score is then calculated as follows: Ratio = (11 x e) / (6 x (66 - r)) (e: effort scale score, r: rewards scale score).
A ratio greater than one indicates an imbalance in favor of efforts.
The last six items make it possible to calculate the score for intrinsic efforts (over commitement).
They relate to the inability to get away from work, impatience and disproportionate irritability.
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time required to complete the self questionnaire estimated at approximately 5 min immediately after consultation with the dermatologist
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 29BRC19.0263
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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