The purpose of this study is to examine the effect parental presence during induction of anesthesia in children undergoing surgery on anxiety and their parents.Sample of study randomly divided intervention and control groups.Inclusion criteria 2 to 11 years old child and exclusion criteria:children can't participate in study. Sample size is 60 that Parents are present in the intervention group.Intervention period is one month.The primary outcome is to evaluate the child's anxiety during induction of anesthesia and their parents and secondary outcome evaluation parental presence on child's anxiety and parents.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013100612830N2
Registration date:2013-12-22, 1392/10/01
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-12-22, 1392/10/01
Registrant information
Name
Faezeh Jahanpour
Name of organization / entity
Bushehr University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 77 1455 0187
Email address
f.jahanpour@bpums.ac.ir
Recruitment status
Recruitment complete
Funding source
BushehrUniversity of Medical Sciences and center Research
Expected recruitment start date
2013-10-23, 1392/08/01
Expected recruitment end date
2013-12-06, 1392/09/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of parental presence on anxiety during induction of anesthesia in children 2 to 11 years old undergoing surgery and their parents
Public title
The effect of parental presence on anxiety of children undergoing surgery and their parents
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Children aged 2 to 11 years old admitted to the surgery; Ability to have hearing and speaking; The normal age-related cognitive abilities; Parent or guardian must be given during the hospitalization. Exclusion Criteria: Patients who have had previous experience of surgery; Chronic diseases (cancer, liver disease, kidney disease) have; Diseases of the central nervous system have.
Age
From 2 years old to 11 years old
Gender
Both
Phase
N/A
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
Bushehr University of health care and Medical Sciences
Street address
Back the Social Security Hospital, Ryshehr, Bushehr
City
Bushehr
Postal code
Approval date
2013-04-10, 1392/01/21
Ethics committee reference number
147
Health conditions studied
1
Description of health condition studied
Generalized anxiety
ICD-10 code
F41.1
ICD-10 code description
Generalized anxiety disorder
Primary outcomes
1
Description
Child Anxiety
Timepoint
After the intervention
Method of measurement
Yale of Anxiety Questionnaire
Secondary outcomes
1
Description
Parental Anxiety
Timepoint
After the intervention
Method of measurement
Espilberger of Anxiety Questionnaire
Intervention groups
1
Description
Parents are present in 2 steps pre and post operative in group the intervention .
Category
Other
2
Description
Control group dont recieve any intervention.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Persian Gulf Hospital, Bushehr
Full name of responsible person
rsti razieh
Street address
Bushehr, University of Medical Science.Bushehr
City
Bushehr
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Bushehr University of Medical Sciences,recearch center
Full name of responsible person
Dr. Afshin Ostovar
Street address
Bushehr, Bushehr University of Medical Sciences
City
Bushehr
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bushehr University of Medical Sciences,recearch center
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
Bushehr University of Medical Sciences
Full name of responsible person
Fazeh Jahanpour
Position
PhD
Other areas of specialty/work
Street address
bushehr university of medical sciences, Bushehr
City
Bushehr
Postal code
00987714550187
Phone
+98 77 1455 0187
Fax
Email
f.jahanpour@bpums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Bushehr University of Medical Sciences
Full name of responsible person
Fazeh Jahanpour
Position
PhD
Other areas of specialty/work
Street address
Bushehr University of Medical Sciences, Bushehr
City
Bushehr
Postal code
Phone
+98 77 1455 0187
Fax
Email
f.jahanpour@bpums.ac.ir
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)