Protocol summary

Summary
The aim of this study was to evaluate the effect of peak flow meter usage on quality of life in asthmatic children. The study population was 80 asthmatic children between 7 to 15 years old. Inclusion criterion was involving in asthma and exclusion criterion was lack of previous peak flow meter usage. The intervention was using (blowing into) peak flow meter device, 3 times a day for 3 months and its outcomes (primary) were activity limitation, symptoms and motivation functions. Finally, upon these primary outcomes, secondary outcome, quality of life, in asthmatic children, was measured.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT138903244163N1
Registration date: 2010-06-14, 1389/03/24
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2010-06-14, 1389/03/24
Registrant information
Name
Iman Ghaffarpasand
Name of organization / entity
Kashan University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 36 1555 1991
Email address
i_ghaffarpasand@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kashan University of Medical Sciences and Health Services
Expected recruitment start date
2009-03-21, 1388/01/01
Expected recruitment end date
2010-01-08, 1388/10/18
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Quality of life in asthmatic children before and after peak-flow-meter usage
Public title
Quality of life in asthmatic children
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Presence of asthma Exclusion criteria: Lack of past peak-flow-meter usage
Age
From 7 years old to 15 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 80
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Kashan University of Medical Sciances and Health Services Ethics Committee
Street address
Ghotb-e-Ravandi Street
City
Kashan
Postal code
8754987111
Approval date
2008-12-02, 1387/09/12
Ethics committee reference number
265-263

Health conditions studied

1

Description of health condition studied
Asthma
ICD-10 code
J45.9
ICD-10 code description
Asthma, unspecified

Primary outcomes

1

Description
Activity limitation
Timepoint
3 months
Method of measurement
Questionnaire

2

Description
Symptoms
Timepoint
3 months
Method of measurement
Questionnaire

3

Description
Motivation functions
Timepoint
3 months
Method of measurement
Questionnaire

Secondary outcomes

1

Description
Quality of life
Timepoint
3 months
Method of measurement
Questionnaire

Intervention groups

1

Description
Using peakflowmeter device (blowing in) 3 times a day for 3 months
Category
Diagnosis

Recruitment centers

1

Recruitment center
Name of recruitment center
Asthma and Allergy Clinic - Shahid Beheshti Hospital
Full name of responsible person
Dr Marzieh Heidarzade
Street address
Ghotb-e-Ravandi Street
City
Kashan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice-chancellor for Research, Kashan University of Medical Sciences and Health Services
Full name of responsible person
Gholam ali Hamidi, PhD
Street address
Ghotb-e-Ravandi Street
City
Kashan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-chancellor for Research, Kashan University of Medical Sciences and Health Services
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Kashan University of Medical Sciences and Health Services
Full name of responsible person
Iman Ghaffarpasand
Position
Student of medicine
Other areas of specialty/work
Street address
Ghotb-e-Ravandi Street
City
Kashan
Postal code
8754987111
Phone
+98 36 1555 0026
Fax
+98 36 1557 5057
Email
Ghaffarpasand@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kashan University of Medical Sciences and Health Services
Full name of responsible person
Marzieh Heidarzadeh
Position
Assistant Professor in pediatric immunology and allergy
Other areas of specialty/work
Street address
Shahid Beheshti hospital
City
Kashan
Postal code
8754987111
Phone
+98 36 1555 0026
Fax
+98 36 1557 5057
Email
M_heidarzade@kaums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Student research committee
Full name of responsible person
Iman Ghaffarpasand
Position
Student of Medicine
Other areas of specialty/work
Street address
Shahid Beheshti hospital
City
Kashan
Postal code
8754987111
Phone
+98 36 1555 2999
Fax
+98 36 1557 5057
Email
ghaffarpasand@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
Loading...