Protocol summary

Summary
(1) Objective: survey of the effect of post transfer to ward care training on anxiety and self efficacy in mothers of hospitalized 1 to 3 years old children in a pediatric cardiac surgery intensive care unit. (2) Design: A randomized controlled trial by Using the method of permuted blocks. (3) intervention: forty mothers of hospitalized children in the intensive cardiac surgery randomly divided in two groups of control and intervention then take pre test of sherer self-efficacy scale(GSES) and Spielberger state and trait anxiety inventory(STAI) in both groups before the intervention. then the intervention group will be trained. motrally after completing the questionnaires the educational booklet provided to the control group . final test will be completed in two groups when children are transfered to cardiac surgery ward. (4)Inclusion criteria: The first of hospitalized in pediatric cardiac surgery intensive care unit; physical and mental health; Mothers in the study do not have the same training program; other children in the family don't have any history of hospitalization. (5) Exclusion criteria: the child's death; transfer the child to another hospital; lack of participation in training meeting even once. (6) interventions: education by training educational booklet. (7) main outcome measures: Changes in the level of anxiety and self-efficacy of mothers

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016110730771N1
Registration date: 2017-07-05, 1396/04/14
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-07-05, 1396/04/14
Registrant information
Name
parvin Sajadian
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 3651 1056
Email address
stud2431926613@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Shiraz University of Medical Science
Expected recruitment start date
2017-01-19, 1395/10/30
Expected recruitment end date
2017-03-20, 1395/12/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Survey of the effect of post transfer to ward care training on anxiety and self efficacy in mothers of hospitalized 1 to 3 years old children in a pediatric cardiac surgery intensive care unit ward
Public title
The effect of Child Care Training on anxiety and self efficacy in mothers of hospitalized children
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: The first hospitaliization of child in pediatric cardiac surgery intensive care unit; physical and mental health; Mothers in the study do not have the same training program; other children in the family don't have any history of hospitalization. Exclusion criteria: the child's death; transfer the child to another hospital; lack of participation in training meetings even once.
Age
From 1 year old to 3 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
in this study the samples allocated by permutation blocks in the intervention and control groups

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Shiraz University of Medical Sciences
Street address
Ethics Committee, seventh floor, Shiraz University of Medical Sciences, next to the Red Crescent headquarters, Zand Ave., Shiraz.
City
Shiraz
Postal code
71348-14336
Approval date
2016-05-15, 1395/02/26
Ethics committee reference number
ir.sums.rec.1395.28

Health conditions studied

1

Description of health condition studied
Congenital Heart Disease
ICD-10 code
q24.9
ICD-10 code description
Congenital malformation of heart, unspecified

Primary outcomes

1

Description
Self efficacy of child care
Timepoint
Before intervention, 4 to 5 days after intervention
Method of measurement
Shere Self -Efficacy scale

2

Description
Anxiety of child care
Timepoint
Before intervention, 4 to 5 days after intervention
Method of measurement
Spielberger state and trait anxiety inventory

Secondary outcomes

empty

Intervention groups

1

Description
intervention group: face to face education given according to the educational booklet to mothers of hospitalized children two days after cardiac surgery
Category
Behavior

2

Description
control group: after completing the questionnaires the educational booklet provided to the control group
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Faghihi Hospital
Full name of responsible person
Mitra Edraki
Street address
Zand Avenue, Shiraz, Iran
City
Shiraz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, 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, Shiraz
City
Fars
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 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
Mitra Edraki
Position
Master Of Nursing
Other areas of specialty/work
Street address
Hazrate Fatemeh Nursing and Midwifery college, Namazi Square, Shiraz
City
Shiraz
Postal code
71936-13119
Phone
+98 71 3647 4286
Fax
+98 71336474252
Email
mitraedraki@yahoo.com
Web page address
nurs-midwif.sums.ac.ir

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
Mitra Edraki
Position
Master Of Nursing
Other areas of specialty/work
Street address
Hazrate Fatemeh Nursing and Midwifery college, Namazi Square, Shiraz
City
Shiraz
Postal code
71936 -13119
Phone
+98 71 3647 4255
Fax
+98 71 3647 4252
Email
mitraedraki@yahoo.com
Web page address
nurs-midwif.sums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Science,Shiraz Hazrate Fatemeh Nursing and Midwifery college
Full name of responsible person
parvin Sajadian
Position
Nursing Graduate Student
Other areas of specialty/work
Street address
Hazrate Fatemeh Nursing and Midwifery college, Namazi Square, Shiraz
City
Shiraz
Postal code
71936-13119
Phone
+98 71 3651 1369
Fax
+98 71 3647 4252
Email
stud2431926613@sums.ac.ir; mitraedraki@yahoo.com
Web page address
nurs-midwif.sums.ac.ir

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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