Anesthesia induction is a stressful event for children and their parents, and may have potentially harmful consequences to the patient’s physiological and mental situation. Traumatic anesthesia induction has psychological consequences that recur with repeated anesthesia, increase pediatric discomfort during the recovery period, and may even induce reactionary postoperative behavior. The aim of this study is to assess the impact of parental presence during induction of anesthesia on anxiety scores in pediatric patients.
This clinical trial will be performed on two groups of 48 children with ASA 1 and 2 undergoing elective minor surgery at Mofid Children Hospital. Parents unwilling to continue the study will be excluded. Both groups will receive Midazolam 0.5 mg/kg at least 20 minutes before surgery but in case group one of the parents will be present in the operating room until induction of anesthesia and loss of consciousness of the patient .Anxiety in children (m-YPAS), parental anxiety (STAI), cooperation of patient with anesthesiologist at induction of anesthesia (ICC) and parental satisfaction (VAS) will be measured. Data collected in two groups will be compared.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017011931497N4
Registration date:2017-02-16, 1395/11/28
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-02-16, 1395/11/28
Registrant information
Name
Afsaneh Sadeghi
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2290 8383
Email address
af.sadeghi@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahaid Beheshti University of Medical Sciences
Expected recruitment start date
2017-02-19, 1395/12/01
Expected recruitment end date
2017-05-22, 1396/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Impact of parental presence during induction of anesthesia on anxiety level among pediatric patients and their parents
Public title
Impact of parental presence on preoperative anxiety of children
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:patients age 4–10 years with ASA 1 or 2 without history of psychiatric disorders and drugs undergoing :elective minor surgery such as inguinal or umbilical hernias ;surgeries less than 1-hour duration with no significant changes in the patient’s hemodynamic parameters
Exclusion criteria:Parents unwilling to continue the study
Age
From 4 years old to 10 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
96
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
Shahid Beheshti University of Medical Science
Street address
Arabi Ave,Daneshjoo Blvd,Velenjak Ave
City
Tehran
Postal code
Approval date
2010-07-04, 1389/04/13
Ethics committee reference number
87/225
Health conditions studied
1
Description of health condition studied
Anxiety
ICD-10 code
F41.9
ICD-10 code description
Anxiety disorder, unspecified
Primary outcomes
1
Description
Preoperative anxiety in children
Timepoint
At ward,at preparation room and immediately before induction of anesthesia
Method of measurement
Modified Yale Preoperative Anxiety Scale
2
Description
Parental anxiety
Timepoint
At ward,at preparation room,immediately before induction of anesthesia
Method of measurement
State And Trait Anxiety Scale
Secondary outcomes
1
Description
Cooperation of child with anesthesiologist at induction of anesthesia
Timepoint
At induction of anesthesia
Method of measurement
Induction Compliance Checklist
2
Description
parental satisfaction
Timepoint
After induction of anesthesia
Method of measurement
visual analog scale
Intervention groups
1
Description
In control group there is no intervention
Category
N/A
2
Description
In intervention group,parents are present at induction of anesthesia until loss of consciousness.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Mofid Children Hospital
Full name of responsible person
Afsaneh Sadeghi
Street address
City
Tehtran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afsaneh Sadeghi
Street address
Arabi Ave,Daneshjoo Blvd,Velenjak Ave
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afsaneh Sadeghi
Position
Anestesiologist
Other areas of specialty/work
Street address
Arabi Ave,Daneshjoo Blvd,Velenjak Ave
City
Tehran
Postal code
Phone
+98 912 407 2892
Fax
Email
af.sadeghi@sbmu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afsaneh Sadeghi
Position
Anesthesiologist
Other areas of specialty/work
Street address
Arabi Ave,Daneshjoo Blvd,Velenjak Ave
City
Tehran
Postal code
Phone
+98 912 407 2892
Fax
Email
af.sadeghi@sbmu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Full name of responsible person
Afsaneh Sadeghi
Position
Other areas of specialty/work
Street address
City
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)