This study will be conducted as randomized control trial in Amirkola Pediatric Hospital, Mazandaran, Iran. The purpose of this study is to evaluate the effects of preoperative preparation program on children's anxiety. The trial, will be performed on 122 children (7-12 years of age) admitted for elective surgery during 15 months. The researcher will randomly assign eligible participants into the experimental and control groups, after pre- test baseline anxiety measurement has taken while admission. The experimental group will receive supportive intervention and the control group will receive routine preoperative information and care. Before the operation the anxiety measurement will be repeated. The anxiety level is the main outcome and will be compared in study groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201104106157N1
Registration date:2011-05-02, 1390/02/12
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-05-02, 1390/02/12
Registrant information
Name
Nazanin Vaezzadeh
Name of organization / entity
Mazandaran University of Medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 15 1226 7345
Email address
vaezzadeh@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Research chancellor of Mazandaran University of Medical Sciences
Expected recruitment start date
2007-03-20, 1385/12/29
Expected recruitment end date
2008-03-19, 1386/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of performing preoperative preparation program on schooled-aged childcare's anxiety
Public title
Assessment the effect of performing preoperative preparation program on childcare's anxiety
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
children aged between 7-12 years, undergoing elective surgery, being able to speak and read Persian language, being accompanied by their mothers (as a close caregiver) on the preoperative assessment day and on the day of surgery.
Exclusion criteria:
Children who had previous surgery or hospitalization after the age of 18 months, developmental delay, use of anti-anxiety medications, chronic illness, and children whose parents were working in health care centers.
Age
From 7 years old to 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
122
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research chancellor of Mazandaran University of Medical Sciences
Street address
moalem street. moalem square
City
sari
Postal code
4816715793
Approval date
2007-03-12, 1385/12/21
Ethics committee reference number
85-147
Health conditions studied
1
Description of health condition studied
CHILDREN'S ANXIETY
ICD-10 code
F41.9
ICD-10 code description
F41.9
Primary outcomes
1
Description
Anxiety level
Timepoint
Before and after intervention
Method of measurement
Questionnaire, observation and record
Secondary outcomes
empty
Intervention groups
1
Description
The supportive intervention in this study included a set of structured activities, designed to psychologically prepare children for surgery according to their developmental stage a day before the surgery. It is consist of a brief explanation on pre and postoperative care, which included information about pre operative fasting time, personal hygiene, control of vital signs, control of loosing teeth, location of dressing, wound care, use of analgesic drugs to relive pain after the surgery.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
amircola teaching therapiutic pediatric center
Full name of responsible person
Street address
City
sari
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research chancellor of mazandadaran university of medical sciences
Full name of responsible person
Dr. ahmadali enayati
Street address
Research chancellor of mazandadaran university of medical sciences, moalem square, moalem street
City
sari
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research chancellor of mazandadaran 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
Mazandaran University of Medical sciences
Full name of responsible person
nazanin vaezzadeh
Position
MSc./ Member of Faculty
Other areas of specialty/work
Street address
Nursing, Nasibeh Nursing and Midwifery school
City
Sari
Postal code
Phone
+98 15 1226 7342
Fax
Email
nvaezzadeh@yahoo.com; Nasibehn83@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical sciences
Full name of responsible person
Zahra Esmaeeli Douki
Position
MSc./ Member of Faculty
Other areas of specialty/work
Street address
Nasibeh Nursing and Midwifery school
City
Sari
Postal code
Phone
+98 15 1226 7342
Fax
Email
zdouki@yahoo.com; Esmaeeli@mazums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical sciences
Full name of responsible person
nazanin vaezzadeh
Position
MSc./ Member of Faculty
Other areas of specialty/work
Street address
Nursing, Nasibeh Nursing and Midwifery school
City
sari
Postal code
4816715793
Phone
+98 15122673425
Fax
+98 15 1226 8915
Email
vaezzadeh@mazums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)