The present research is a parallel semi-experimental study conducted to investigate the influence of kids’ special care program on the clinical state and anxiety of the child and parents who have undergone general surgery. This research will take place in 2016 during which 64 kids candidate for general surgery will be studied for 6 months from recovery up to the time when they were discharged. The entrance criteria included: aging 4 to 5 years old, having undergone a general surgery, gaining the agreement of both parents and the kid, and having one of the parents as the attendant with kid. The exit criteria included: especial problems during operation or anesthesia, a background of hospitalization and surgery, and a background of chronic diseases. The patients will be randomly divided into the control and test groups. The control group received the routine post-surgery cares in recovery room from nurses. As of the intervention group, personnel will attend classes and receive practical or question and answer training's in accordance with educational demands and care standards of their ward. In this group, parents are allowed to visit the kid while he is in recovery room. The clinical state and the anxiety of the kid and parents before and after surgery will be checked in both groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016030526918N1
Registration date:2016-06-15, 1395/03/26
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-06-15, 1395/03/26
Registrant information
Name
Saeid Pasban Noghabi
Name of organization / entity
Tarbiat Modares University
Country
Iran (Islamic Republic of)
Phone
+98 915 655 4507
Email address
s.pasban@modares.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research; Tarbiat Modares university.
Expected recruitment start date
2016-04-08, 1395/01/20
Expected recruitment end date
2016-09-10, 1395/06/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of special designed care plan on clinical condition, child and parent anxiety of general surgery child from recovery unit discharge
Public title
The effect of special designed care plan on clinical condition, child and parent anxiety of general surgery child from recovery unit discharge
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Age between 4-5 years old; have general surgery; Satisfaction of parents; Attend of parent.
Exclusion criteria: History of hospitalization; History of chronic disease.
Age
From 4 years old to 5 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
64
Randomization (investigator's opinion)
Not 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
Ethics committee of Tarbiat Modares University .
Street address
Tehran, Iran
City
Tehran
Postal code
Approval date
2015-04-28, 1394/02/08
Ethics committee reference number
IR.TMU.REC.1394.41
Health conditions studied
1
Description of health condition studied
Anxiety of child and parents
ICD-10 code
F93.0
ICD-10 code description
Separation anxiety disorder of childhood
2
Description of health condition studied
Clinical condition of child
ICD-10 code
Z09.0
ICD-10 code description
Follow-up examination after surgery for other conditions
Primary outcomes
1
Description
Child Anxiety
Timepoint
Before and after surgery
Method of measurement
Designed tool
2
Description
Parent Anxiety
Timepoint
Before and after surgery
Method of measurement
Spilberger questionnaire
3
Description
Clinical condition of child
Timepoint
Before surgery; recovery and in surgery ward
Method of measurement
Designed tool
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:
Inter-section education for nurse in 7-10 Session. We use pamfelet, Practical training, poster and computer.
Category
Prevention
2
Description
Control group:
No intervention.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Doctor Sheikh Hospital
Full name of responsible person
Saeid Pasban-Noghabi
Street address
Majd street, Doctor Sheikh Hospital.
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research, Tarbiat Modares School of Medical Sciences.
Full name of responsible person
Yaghob Fathollahi
Street address
Tehran
City
Tehran
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, Tarbiat Modares School 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
Department of Nursing; School of Medical Sciences; Tarbiat Modares University.
Full name of responsible person
Saeid Pasban-Noghabi
Position
Student
Other areas of specialty/work
Street address
Tehran
City
Tehran
Postal code
Phone
+98 21 8288 3554
Fax
Email
s.pasban@modares.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Department of Nursing; School of Medical Sciences; Tarbiat Modares University.
Full name of responsible person
Dr. Robabe Memarian
Position
Assistant professor
Other areas of specialty/work
Street address
Tehran
City
Tehran
Postal code
Phone
+98 21 8288 3554
Fax
Email
memarian.dr@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Department of Nursing; School of Medical Sciences; Tarbiat Modares University.
Full name of responsible person
Saeid Pasban-Noghabi
Position
Other areas of specialty/work
Street address
Tehran
City
Postal code
Phone
00
Fax
Email
s.pasban@modares.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)