Protocol summary

Summary
Objective: to investigation the effect of parental education on happening of medication errors in children aged 1-5 years, reffering to selected shiraz clinics in 2016.Design: A randomized controlled trial will be conducted. Setting and conduct: Three clinics will be selected by two-stage cluster sampling , Then 120 parents attending to one of the three clinics will be selected at random assignment .parents After completing the pre-test medication errors, with Random block will be divided into intervention and control groups then Educational content will be available to intervention group. Four days after receiving the content, the two groups will complete their post-test medication errors and educational booklet will be given them . Inclusion criteria: Parents of children aged one to five years; informed consent and willingness to participate in the study; presence of father or mother or both parents in training session. Exclusion criteria: Ill child and his transfer to the hospital for admission; Non-prescribed medicines by doctor for children; Subjects not participating in the training session. interventions: PowerPoint training by lecture. main outcome measures: Changes in happening of medication errors and prevent the occurrence of medication errors in children 1 to 5 years old parents

General information

Acronym
-
IRCT registration information
IRCT registration number: IRCT2016091229291N1
Registration date: 2016-09-12, 1395/06/22
Registration timing: prospective

Last update:
Update count: 0
Registration date
2016-09-12, 1395/06/22
Registrant information
Name
Zahra Mohammadi
Name of organization / entity
Shiraz University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 71 3230 5410
Email address
mohamadyza@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research of Shiraz University of Medical Science
Expected recruitment start date
2016-09-20, 1395/06/30
Expected recruitment end date
2017-01-19, 1395/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
investigation the effect of parental education on happening of medication errorsin children aged 1-5 years, reffering to selected shiraz clinics in 2016
Public title
the effect of parental education on happening of medication errors
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: presence of father or mother or both parents in training session; informed consent and willingness to participate in the study; Parents of children aged one to five years. Exclusion criteria: Ill child and his transfer to the hospital for admission; Subjects not participating in the training session; Non-prescribed medicines by doctor for children .
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 120
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Three clinics will be selected by two-stage cluster sampling , Then 120 parents attending to one of the three clinics will be selected at random assignment .parents After completing the pre-test medication errors, with Random block will be divided into intervention and control groups

Secondary Ids

1

Registry name
-
Secondary trial Id
-
Registration date
empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Shiraz University of Medical Science
Street address
Central Building of Shiraz University of Medical Sciences, Zand Street
City
Shiraz
Postal code
71348-14336
Approval date
2016-06-26, 1395/04/06
Ethics committee reference number
IR.SUMS.REC.1395.56

Health conditions studied

1

Description of health condition studied
Medication Errors
ICD-10 code
-
ICD-10 code description
-

Primary outcomes

1

Description
Medication errors
Timepoint
before intervention and 4days after intervention
Method of measurement
Medication errors questionnaire

Secondary outcomes

1

Description
-
Timepoint
-
Method of measurement
-

Intervention groups

1

Description
Control group: No intervention is needed
Category
Treatment - Drugs

2

Description
Intervention group :Holding training sessions for 40 minute About the types of medication errors, various forms of medication, how to use various forms of drugs, Respect the important principles while taking the drugs and Storage of medicines Before seeing the child by doctor and holding training sessions of 15 minutes after the child visit
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Fatemeh Zahra Clinic
Full name of responsible person
Dr Reza Mohammadi,General Practitioner
Street address
Hemmat jonoobi Blvd
City
Shiraz

2

Recruitment center
Name of recruitment center
Boarding Clinic Eghbal
Full name of responsible person
Somaye Ebrahimi, Public Health Expert
Street address
Pasargad Square, Pasargad Boulevard
City
Shiraz

3

Recruitment center
Name of recruitment center
Shahid Meftahi
Full name of responsible person
Dr Zahra Rezaianzadeh,General Practitioner
Street address
Shahid Fakoori Street, five army units Street, Rahmat Blvd,
City
Shiraz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research of Shiraz University of Medical Science
Full name of responsible person
Dr Seyed Basir Hashemi
Street address
Vice chancellor for research, seventh floor, Shiraz University of Medical Sciences, next to the Red Crescent headquarters, Zand Ave
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 of Shiraz University of Medical Science
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 Science, Shiraz Hazrate Fatemeh Nursing and Midwifery college
Full name of responsible person
Zohreh Montaseri
Position
Master of Pediatric Nursing, Nursing Trainer
Other areas of specialty/work
Street address
Namazi Square, Shiraz Hazrate Fatemeh Nursing and Midwifery college
City
Shiraz
Postal code
71936 -13119
Phone
+98 71 3647 4255
Fax
+98 71 3647 4252
Email
montaseriz@sums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Science, Shiraz Hazrate Fatemeh Nursing and Midwifery College
Full name of responsible person
Zohreh Montaseri
Position
Master of Pediatric Nursing, Nursing Trainer
Other areas of specialty/work
Street address
Namazi Square, Shiraz Hazrate Fatemeh Nursing and Midwifery College
City
Shiraz
Postal code
71936 -13119
Phone
+98 71 3647 4255
Fax
+98 71 3647 4252
Email
montaseriz@sums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Science, Hazrate Fatemeh Nursing and Midwifery College
Full name of responsible person
Zahra Mohammadi
Position
Children's Nursing Graduate Student
Other areas of specialty/work
Street address
Namazi Square, Hazrate Fatemeh Nursing and Midwifery College
City
Shiraz
Postal code
Phone
+98 71 3647 4255
Fax
Email
mohamadyza@sums.ac.ir
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
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