Objectives: Determining the effect of education on anxiety and self-efficacy in mothers of 1-3-year-old children under glaucoma surgery. Design: Randomized clinical trial. Setting and conduct: This study is conducted on 60 mothers of 1-3-year-old children admitted in the pediatric eye surgery department at Shiraz Khalili Hospital who are eligible for the study. Subjects are first selected through purposive sampling method to achieve the desired sample size, and then they are divided in to two experimental (n = 30) and control groups (n = 30) using simple randomized sampling allocation, through RA software. Educational interventions are held for the experimental group during two training sessions, with one week interval, regarding the illness, recovery process and necessary post-surgery care for children. There are no interventions for the control group. The level of anxiety and self-efficacy in the mothers is measured by having them fill out the Spielberger state-trait anxiety inventory questionnaire and the Sherer self-efficacy questionnaire during the admission and after the surgery by the two experimental and control groups and the results are compared together. The inclusion criteria: No history of hospitalization in the child; the patient being the first child in the family; no mental problem in the mothers; no record of mother’s participation in the respective courses. The exclusion criteria: The mother's unwillingness to cooperate in the study. The main outcome measures (variables): mother’s anxiety and self-efficacy
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201704032432N4
Registration date:2017-07-12, 1396/04/21
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-07-12, 1396/04/21
Registrant information
Name
Azadeh Amiri
Name of organization / entity
Shiraz University Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1647 4254
Email address
amiriea@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Shiraz University of Medical Sciences
Expected recruitment start date
2017-02-19, 1395/12/01
Expected recruitment end date
2017-06-22, 1396/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Examining the effect of education on anxiety and self-efficacy in mothers of 1-3-year-old children under glaucoma surgery
Public title
The impact of education on anxiety and self-efficacy in mothers of children under glaucoma surgery
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion Criteria: No history of hospitalization in the child; the patient being the first child in the family; no mental problem in the mothers; and no record of mother’s participation in the respective courses. Exclusion Criteria: Mother's unwillingness to cooperate in the study.
Age
No age limit
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
60
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
Ethics committee of Shiraz University of Medical Sciences
Street address
Shiraz University of Medical Sciences,Zand Street, Shiraz
City
Shiraz
Postal code
Approval date
2017-05-02, 1396/02/12
Ethics committee reference number
IR.SUMS.REC.1396.17
Health conditions studied
1
Description of health condition studied
Glaucoma
ICD-10 code
Q15.0
ICD-10 code description
Congenital glaucoma
2
Description of health condition studied
Anxiety
ICD-10 code
F41.1
ICD-10 code description
Generalized anxiety disorder
Primary outcomes
1
Description
Anxiety
Timepoint
Before intervention during admission and after intervention following surgery
Before intervention during admission and after intervention following surgery
Method of measurement
Sherer self-efficacy questionnaire
Intervention groups
1
Description
The control group receives routine care.
Category
Other
2
Description
In the intervention group, educational interventions are held during two training sessions regarding the illness, recovery process and necessary post-surgery care for children.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Khalili Hospital affiliated to Shiraz University of Medical Sciences, Shiraz, Iran
Full name of responsible person
Azadeh Amiri
Street address
Namazi Square, Zand Street, 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. Seyed Basir Hashemi
Street address
Shiraz University of Medical Sciences, Zand Street, Shiraz
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
School of Nursing and Midwifery, Shiraz University of Medical Sciences
Full name of responsible person
Azadeh Amiri
Position
Master of Science In Nursing, Faculty member of School of Nursing and Midwifery, Shiraz University o
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Namazi Square, Zand Street, Shiraz
City
Shiraz
Postal code
7193613119
Phone
+98 71 3647 4258
Fax
+98 71 3647 4252
Email
amiriea@sums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
School of Nursing and Midwifery, Shiraz University of Medical Sciences
Full name of responsible person
Azadeh Amiri
Position
Master of Science In Nursing, Faculty member of School of Nursing and Midwifery, Shiraz University o
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Namazi Square, Zand Street, Shiraz
City
Shiraz
Postal code
7193613119
Phone
+98 71 3647 4258
Fax
+98 71 3647 4252
Email
amiriea@sums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
School of Nursing and Midwifery, Shiraz University of Medical Sciences
Full name of responsible person
Azadeh Amiri
Position
Master of Science In Nursing, Faculty member of School of Nursing and Midwifery, Shiraz University o
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Namazi Square, Zand Street, Shiraz
City
Shiraz
Postal code
7193613119
Phone
+98 71 3647 4258
Fax
+98 71 3647 4252
Email
amiriea@sums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)