The effect of training the usage of inhaler with and without spacer on pulmonary function and skill of inhaler aplication in patient with asthma referring to selected clinics of shiraz university of medical science
Objective: this study is a randomized clinical trial on 90 patients with asthma in selected clinics in Shiraz (Faghihi and Motahary) was performed to evaluate the effect of training the usage of inhaler with and without spacer on pulmonary function and skill of inhaler application in patient with asthma. Design: after obtaining informed consent, eligible patients were randomly assigned to three groups: group inhalation technique with spacer; group of inhalation technique without spacer and control. Methods: we measured the peak expiratory flow rate with peak flow meter before and after inhalation of salbutamol 200 micrograms, as a basic test in the three groups,and also skill of inhaler application were evaluated with inhalation techniqu chek list in three groups . in the next step three educational sessions were held. In spacer group were taught how to use inhaler with spacer and in without spacer group were tough how to use inhaler without spacer. The control group received no intervention. Then lung test and skill of inhaler application was measured immediately and one month after education. Inclusion criteria: being in the age range 60-18 years old; the use of salbutamol production in Sina Daru Company for at least three months; not to participate in a similar training program. Exclusion criteria: smoking; patient unwillingness to continue cooperation; Asthma Attack. Intervention: teaching correct use of spray with spacer and Teaching correct use of spray without spacer.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013091514666N1
Registration date:2013-11-23, 1392/09/02
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-11-23, 1392/09/02
Registrant information
Name
Fatemeh Ansarfard
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 72 2446 3290
Email address
ansarfard_f@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Shiraz University of Medical Sciences
Expected recruitment start date
2013-04-21, 1392/02/01
Expected recruitment end date
2013-06-20, 1392/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of training the usage of inhaler with and without spacer on pulmonary function and skill of inhaler aplication in patient with asthma referring to selected clinics of shiraz university of medical science
Public title
The effect of training the usage of inhaler with and without spacer on pulmonary function and skill of inhaler aplication in patient with asthma
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Asthma diagnosed by a physician; age between 18-60 years old; willingness to participate in research; physical ability to usage spray; access to telephone to follow-up program by the researcher; use of salbutamol spray at least three months; not affected by heart disease, pneumonia, pneumothorax, and other systemic diseases; not participated in a similar training program; ability reading and writing (at least at the basic level of education) and understand Persian.
Exclusion criteria: absence in training sessions; unwillingness to continue or discontinue patient cooperation in the during of study for any reason; asthma attack; smoking; change the treatment plan.
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shiraz University of Medical Sciences Ethics Committee
Street address
7th floor, Central Building of Shiraz University of Medical Sciences, Zand Street, Shiraz, Fars Province, Iran, 1978 -71345
City
shiraz
Postal code
71345-1978
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
6675
Health conditions studied
1
Description of health condition studied
Asthma
ICD-10 code
J45
ICD-10 code description
Asthma
Primary outcomes
1
Description
Peak expiratory flow rate
Timepoint
Before education, immediately and one month after education
Method of measurement
Peak flow meter
2
Description
skill of inhaler application
Timepoint
Before education, immediately and one month after education
Method of measurement
inhalation technique check list
Secondary outcomes
1
Description
Adverse effects after inhalation of drug
Timepoint
Before education, immediately and one month after education
Method of measurement
Observation
Intervention groups
1
Description
intervention1: spacer group were trained the correct use of inhaler with spacer.
First session was about recognition of symptoms of asthma, including definition, etiology and drug treatment .Second session was about emphasis on importance of correct use of spray with spacer and advantages of using spacer for patients and its positive impact on the treatment process
Also patients were taught correct use of inhaler with spacer Practically .
and Third Session was about Summary of inhalation technique with spacer, review and eliminate pitfall of inhalation technique.
Category
Prevention
2
Description
intervention 2: without spacer group: were trained the correct use of inhaler without spacer
First session was about recognition of symptoms of asthma, including definition, etiology and drug treatment .Second session was about emphasis on importance of correct use of spray for patients and its positive impact on the treatment process
Also patients were taught correct use of inhaler without spacer Practically .
and Third Session was about Summary of inhalation technique, review and eliminate pitfall of inhalation technique.
Category
Treatment - Drugs
3
Description
intervention3: The control group received no intervention. Finally the both types of inhalation technique were presented to the patients through pamphlets
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Faghihi and Motahari clinics
Full name of responsible person
Dr moham Ali Ghayomi
Street address
Sixth floor, Motahari clinic, Shiraz
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Shiraz University of Medical Sciences
Full name of responsible person
Dr. Gholamreza Hatam
Street address
7th floor, Central Building of Shiraz University of Medical Sciences, Zand Street, Shiraz, Fars Province
City
Shiraz
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, Shiraz University of Medical Sciences
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
Shiraz University of Medical Sciences
Full name of responsible person
Mr. Hashem Rahmati
Position
Master of nursing
Other areas of specialty/work
Street address
Hazrat-e-Fatemeh nursing and midwifery college, Namazi Hospital, Namazi Square, Shiraz.
City
Shiraz
Postal code
71345-1978
Phone
+98 71 1647 4254
Fax
+98 71 1627 9135
Email
h_rahmati@yahoo.com
Web page address
www.sums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Hashem Rahmati
Position
Master of nursing
Other areas of specialty/work
Street address
Hazrat-e-Fatemeh nursing and midwifery college, Namazi Hospital, Namazi Square, Shiraz.
City
Shiraz
Postal code
71345-1978
Phone
+98 71 1647 4254
Fax
+98 71 1627 9135
Email
H-Ramati1076@yahoo.com
Web page address
www.sums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Ansarfard Fatemeh
Position
Master student of nursig
Other areas of specialty/work
Street address
Hazrat-e-Fatemeh nursing and midwifery college, Namazi Hospital, Namazi Square, Shiraz.
City
Shiraz
Postal code
Phone
Fax
+98 71 1212 2430
Email
ansarfard_f@sums.ac.ir; fatemeh102@yahoo.com
Web page address
www.sums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)