Comparison between nasal mucosiliary clearance in children with moderate to severe allergic rhinitis in two groups treated with or without normal saline irrigation
Comparison of nasal mucociliary clearance in children with moderate and severe allergic rhinitis treated with and without normal saline irrigation
Design
This study is a clinical trial with a control group, with crossover groups , without blinding, with block randomization. It will be done on 108 children aged 6 to 12 with a history of seasonal allergic rhinitis.
Random Allocation Software will be used for randomization.
Settings and conduct
Nasal cleansing test will be measured before and 4 weeks after nasal washing in all patients.
54 children will be taught to wash their nose regularly 3 times a day with normal saline solution for 6 weeks, and 54 patients will not wash their nose with normal saline.Also , the patients of both groups will be treated with oral antihistamine drugs at the same time, and the amount of antihistamine drug consumption will be collected at the end of each week.This study is done in Ayatollah Motahari hospital of urmia in 1402.
Participants/Inclusion and exclusion criteria
Entrance: 1) 6-12 year old children with moderate and severe allergic rhinitis
Exit:
1) Children with non-allergic rhinitis
2) Children with adenoide hyperplasia,bening and malignant tumors,pemphigus,nasal foreign
body or nasal polyp
3) Any trauma during the review period
Intervention groups
Nasal cleansing test will be measured before and 4 weeks after nasal washing in all patients.
54 children will be taught to wash their nose regularly 3 times a day with normal saline solution for 6 weeks, and 54 patients will not wash their nose with normal saline.Also , the patients of both groups will be treated with oral antihistamine drugs at the same time, and the amount of antihistamine drug consumption will be collected at the end of each week.
Main outcome variables
Mucociliary clearance time,Quality of life of children with allergic rhinitis
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20231016059741N1
Registration date:2023-11-06, 1402/08/15
Registration timing:registered_while_recruiting
Last update:2023-11-06, 1402/08/15
Update count:0
Registration date
2023-11-06, 1402/08/15
Registrant information
Name
Maryam Dabbagh Shahir
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 44 3224 8760
Email address
m4ry4m.dsh@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-09-23, 1402/07/01
Expected recruitment end date
2024-03-19, 1402/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison between nasal mucosiliary clearance in children with moderate to severe allergic rhinitis in two groups treated with or without normal saline irrigation
Public title
Comparison between nasal mucosiliary clearance in children with moderate to severe allergic rhinitis in two groups treated with or without normal saline irrigation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
6-12 year old children with moderate and severe allergic rhinitis
Exclusion criteria:
Children with adenoide hyperplasia,bening and malignant tumors,pemphigus,nasal foreign body or nasal polyp
Any trauma during the review period
Age
From 6 years old to 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
108
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization will be by the block randomization method,so that first the blocks will be listed in the size of 6 of combination(AAABBB) and a code will be assigned to each one, and then according to the sample size (108) and Blocks(6) in the number of 17 blocks will be selected using simple randomization method.All this process will be done using Random Allocation Software under the supervision of an epidemiologist.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Urmia University of Medical Sciences
Before and 4 weeks after washing the nose with normal saline
Method of measurement
Minute
Secondary outcomes
1
Description
Quality of life of children with allergic rhinitis
Timepoint
Before and 4 weeks after washing the nose with normal saline
Method of measurement
According to the patients file
Intervention groups
1
Description
Intervention group:Nasal cleansing test will be measured before and 4 weeks after nasal washing in all patients. 54 children will be taught to wash their nose regularly 3 times a day with normal saline solution for 6 weeks .Also , the patients will be treated with oral antihistamine drugs , and the amount of antihistamine drug consumption will be collected at the end of each week.
Category
Diagnosis
2
Description
Control group:Nasal cleansing test will be measured before and 4 weeks after nasal washing in all patients.54 patients will not wash their nose with normal saline.Also , the patients of will be treated with oral antihistamine drugs, and the amount of antihistamine drug consumption will be collected at the end of each week.