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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04316533
Other study ID # 29BRC19.0263
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 9, 2020
Est. completion date June 30, 2020

Study information

Verified date July 2020
Source University Hospital, Brest
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Work stress and pruritus: imbalance of effort balance reward in patients with psoriasis.


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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date June 30, 2020
Est. primary completion date June 30, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
France Chru Brest Brest Finistère

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Brest

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Pruritus' impact on quality of life 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. time required to complete the self questionnaire estimated at approximately 5 min immediately after consultation with the dermatologist
Secondary Occupational stress 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. time required to complete the self questionnaire estimated at approximately 5 min immediately after consultation with the dermatologist
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