(1) Objectives: Compare the effectiveness of educative story book with face-to-face education on anxiety of hospitalized children and their mothers. (2) Design: The research project is a quasi-experimental design with pretest and post test. The subjects consist of 81 hospitalized children 6-9 years old and their mothers in Sabzevar, who are selected by availability method. (3) Setting and conduct: The subjects are selected by availability method, and then are randomly are allocated in educative story book, face-to-face education and routine method groups. (4) Participants including major eligibility criteria: The subjects consist of 81 hospitalized children 6-9 years old in Sabzevar that had been admitted for the first time at hospital; none-use of sedatives and anti-anxiety drugs. Exclusion criteria: Administration of sedatives and anti-anxiety drugs; discharge with personal satisfaction; hospitalized more than a week. (5) Intervention: In one group orientation program is done by educative story book, in two group orientation program is face to face and other is routine. Intervention time: When patients and their mothers enter the ward. (6) Main outcome measures variables: Anxiety of hospitalized children and their mothers
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015091021663N2
Registration date:2015-10-22, 1394/07/30
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-10-22, 1394/07/30
Registrant information
Name
Shahrbano Talebi
Name of organization / entity
Sabzevar University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 4464 4351
Email address
talebi.sh@medsab.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Sabzevar University of Medical Sciences
Expected recruitment start date
2015-06-22, 1394/04/01
Expected recruitment end date
2015-08-23, 1394/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Compare the effectiveness of educative story book with face-to-face education on anxiety of hospitalized children and their mothers
Public title
Compare the effectiveness of educative story book with face-to-face education on anxiety of hospitalized children and their mothers
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Hospitalized children between 6 to 9 years old that had been admitted for the first time at hospital; Children and mothers without any mental retardation, malignancy and other chronic diseases; none-use of sedatives and anti-anxiety drugs; parental and child consent. Exclusion criteria: Administration of sedatives and anti-anxiety drugs; discharge with personal satisfaction; hospitalized more than a week.
Age
From 6 years old to 48 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
81
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Children with their mothers are divided by lottery method into two groups of intervention and one group of control
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Sabzevar University of Medical Sciences
Street address
Ethics Committee of Sabzevar University of Medical Sciences, Sabzevar University of Medical Sciences, 5 km road Sabzevar - Tehran, Sabzevar, Khorasan Razavi, Iran
City
Sabzevar
Postal code
Approval date
2014-12-29, 1393/10/08
Ethics committee reference number
Medsab.Rec.93.64
Health conditions studied
1
Description of health condition studied
Anxiety
ICD-10 code
F41.1
ICD-10 code description
Anxiety that is generalized and persistent but not restricted to, or even strongly predominating in, any particular environmental circumstances (i.e. it is
Primary outcomes
1
Description
Anxiety
Timepoint
Patient admission and discharge time
Method of measurement
Questionnaire: The scale of facial self-reported anxiety for children and questionnaire: The state anxiety for mothers
Secondary outcomes
1
Description
-
Timepoint
-
Method of measurement
-
Intervention groups
1
Description
Intervention: Education is done by educative story book from admission until discharge time
Category
Behavior
2
Description
Intervention: Education is done by face to face method from admission until discharge time
Category
Behavior
3
Description
Control: Education is done by routine method from admission until discharge time
Vice chancellor for research, Sabzevar University of Medical Sciences
Full name of responsible person
Mohammad Mohammadzadeh
Street address
Vice Chancellor for Education, Building number two, Sabzevar University of Medical Sciences and Health Services, 5 km road Sabzevar – Tehran, Sabzevar, Khorasan Razavi, Iran
City
Sabzevar
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, Sabzevar 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
Sabzevar University of Medical Sciences
Full name of responsible person
Javad Ganjloo
Position
Nursing instructor
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Sabzevar University of Medical Sciences, 5 km road Sabzevar - Tehran, Sabzevar, Khorasan Razavi, Iran
City
Sabzevar
Postal code
9613873136
Phone
+98 51 4444 5994
Fax
Email
jganj@yahoo.com
Web page address
medsab.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Shahrbano Talebi
Position
Nursing postgraduate student
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Sabzevar University of Medical Sciences, 5 km road Sabzevar - Tehran, Sabzevar, Khorasan Razavi, Iran
City
Sabzevar
Postal code
9617868311
Phone
+98 51 4464 4351
Fax
Email
shtslebi12@yahoo.com
Web page address
medsab.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Sabzevar university of medical sciences
Full name of responsible person
Shahrbano Talebi
Position
Student
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Sabzevar University of Medical Sciences, 5 km road Sabzevar - Tehran, Sabzevar, Khorasan Razavi, Iran
City
Sabzevar
Postal code
9617868311
Phone
+98 51 4464 4351
Fax
Email
shtslebi12@yahoo.com
Web page address
medsab.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)