Effect of educational program versus control group on the treatment of patients with chronic contact hand dermatitis: a single-blind randomized clinical trial
To assess the effect of educational program versus control group on the treatment of patients with chronic contact hand dermatitis
Design
This is a single-blind randomized clinical trial with control group, in which eligible patients will be randomly assigned through the block randomization to the intervention and control groups
Settings and conduct
This study will be performed in the Sina Hospital in Hamadan city on 90 eligible patients with chronic contact hand dermatitis. The patients will be randomly assigned to the intervention and control groups through the block randomization. This trial will be single-blinded.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age 18 to 65 years
Chronic contact dermatitis for at least 6 months
Middle school and higher education
Exclusion criteria:
Pregnancy
Other skin diseases such as psoriasis, lupus or dermatomiosis
Use of topical or systemic corticosteroids in the past week
Use of immunosuppressive drugs in the past three months
Intervention groups
Intervention group:
Routine treatment of contact dermatitis plus care education program (including how to wash hands, dry hands, use moisturizing cream, wear gloves) for 45 minutes once every two weeks for 12 weeks
Control group:
Routine treatment of contact dermatitis
Main outcome variables
Primary outcome:
Improvement of chronic hand contact dermatitis
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120215009014N439
Registration date:2022-08-29, 1401/06/07
Registration timing:prospective
Last update:2022-08-29, 1401/06/07
Update count:0
Registration date
2022-08-29, 1401/06/07
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-09-23, 1401/07/01
Expected recruitment end date
2024-01-21, 1402/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of educational program versus control group on the treatment of patients with chronic contact hand dermatitis: a single-blind randomized clinical trial
Public title
Effect of educational program versus control group on the treatment of patients with chronic contact hand dermatitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18 to 65 years
Chronic contact dermatitis for at least 6 months
Middle school and higher education
Exclusion criteria:
Pregnancy
Other skin diseases such as psoriasis, lupus or dermatomiosis
Use of topical or systemic corticosteroids in the past week
Use of immunosuppressive drugs in the past three months
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
The patients will be randomly assigned to intervention and control groups using block randomization. For this purpose, we will prepare four sheets of paper, writing on two sheets the name of the intervention and on the other two sheets the name of the control. The paper sheets will be pooled, placed in a container, and randomly drawn one at a time for each patient without replacement until all four sheets are drawn. The four paper sheets will be then placed back into the container, and this action repeated until the sample size is reached.
Blinding (investigator's opinion)
Single blinded
Blinding description
The physician who will examine the patients will not be aware of the intervention. Thus, the trial will be run as single-blind.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Approval date
2022-08-20, 1401/05/29
Ethics committee reference number
IR.UMSHA.REC.1401.465
Health conditions studied
1
Description of health condition studied
Contact dermatitis
ICD-10 code
L23
ICD-10 code description
Allergic contact dermatitis
Primary outcomes
1
Description
Severity of chronic hand contact dermatitis
Timepoint
In the first, sixth and twelfth weeks after the intervention
Method of measurement
By taking history and clinical examination
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Routine treatment of contact dermatitis plus care education program (including how to wash hands, dry hands, use moisturizing cream, wear gloves) for 45 minutes once every two weeks for 12 weeks
Category
Treatment - Other
2
Description
Control group: Routine treatment of contact dermatitis
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Sina Hospital in Hamadan city
Full name of responsible person
Saba Beigiparast
Street address
Sina Hospital, Mirzadeh Eshghi Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3827 4184
Email
sababeigiparast@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Reza Shokoohi
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0717
Email
info.research@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Saba Beigiparast
Position
Medical Student
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
School of Medicine, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
sababeigiparast@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Bahareh Ebrahimi
Position
Dermatologist
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
School of Medicine, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
b.ebrahimi.4362@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Jalal Poorolajal
Position
Professor of Epidemiology
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Email
poorolajal@umsha.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available