Quality of Life in Patients With Chronic Urticaria

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03163875
Recruitment Status : Not yet recruiting
First Posted : May 23, 2017
Last Update Posted : May 30, 2017
Information provided by (Responsible Party):
AMAbdelgawad, Assiut University

Brief Summary:
Urticaria is one of the most frequent presenting complaints in dermatology, allergy, and emergency departments. The term chronic urticaria (CU) is understood as the appearance of recurrent wheals more than twice a week for over 6 consecutive weeks .Urticaria is not a single disease but a reaction pattern that represents cutaneous mast cell degranulation, resulting in extravasation of plasma into the dermis. The incidence of chronic urticaria is unknown, but it is thought to occur in 0.1%-3% of the population

Condition or disease Intervention/treatment
Chronic Urticaria Other: Hospital Anxiety and Depression Scale

Detailed Description:

Chronic urticaria signs and symptoms include: patches of red or white wheals, usually on the face, trunk, arms or legs. Wheals vary in size, change shape, and appear and fade repeatedly as the reaction runs its course. Itching is common, which may be severe. Swelling may occur that causes pain or burning (angioedema), especially inside the throat and around the eyes, cheeks, lips, hands, feet and genitals.

It is characterized by a tendency for signs and symptoms to flare with triggers such as heat, exercise and stress as well as a tendency for symptoms to recur frequently and unpredictably, sometimes for months or years The significance of chronic urticaria is sometimes trivialised because it is a non-life-threatening disease, but the condition can be very uncomfortable and interfere with sleep and daily activities. It is one of the most common and frustrating diseases for both patients and physicians Chronic urticaria has a major impact on quality of life (QoL) , with impact on activities of daily living. Chronic urticaria patients reportedly suffer considerable loss of energy, sleep disturbance and emotional upset as well as restrictions in the social life. Depression and anxiety are the most common psychiatric diagnoses. These psychiatric disorders could also influence QoL

Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Quality of Life,Anxity,Depression and Quality of Sleep in Patients With Chronic Urticaria
Estimated Study Start Date : June 1, 2017
Estimated Primary Completion Date : June 10, 2018
Estimated Study Completion Date : August 1, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety Hives

Intervention Details:
  • Other: Hospital Anxiety and Depression Scale
    To assess the levels of depression and anxiety, quality of sleep and quality of life (QoL) in chronic urticaria patients, using an interdisciplinary approach combining interview/questionnaire-based psychiatric and dermatological evaluations

Primary Outcome Measures :
  1. measure number of patients affected with depression and anxity [ Time Frame: one year ]
    The levels of depression and anxiety will be assessed by Hospital Anxiety Depression Scale (HADS) .

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Antihistamines will be discontinued at least 72 h prior to evaluation.

Inclusion Criteria:

Patients with chronic urticaria defined as a 6-week or longer history of daily or almost daily itchy cutaneous weals with individual lesions lasting less than 24 h.

Age between 18 and 60 years.

Exclusion Criteria:

Patients who are unable to understand the questions, are unwilling to complete the questionnaire, or who have a psychiatric disorder, or obstructive sleep apnea.

Patients with malignant or central nervous system disease. Patients with cognitive impairment due to a current cerebral or psychotic illness.

Patients with current psychotherapy . glucocorticoids therapy in the last month.

Responsible Party: AMAbdelgawad, principle investigator, Assiut University Identifier: NCT03163875     History of Changes
Other Study ID Numbers: ziad
First Posted: May 23, 2017    Key Record Dates
Last Update Posted: May 30, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by AMAbdelgawad, Assiut University:
wheal formation
vascular reaction of the skin

Additional relevant MeSH terms:
Skin Diseases, Vascular
Skin Diseases
Hypersensitivity, Immediate
Immune System Diseases