This study is a clinical trial 2×2 factorial design. Factors studied method and time of preoperative preparation program. The aim of this study compare the effect of preoperative preparation program with different method and time on anxiety of school age children and their parents. Inclusion criteria include: "The children ranged from 6 to 12 years";"pediatric surgery as apply on day care unit (hospitalization up to 1 day";"Speech, vision and hearing well";"do not have psychological disease";"children are not single parent";"children did not have surgery before";"surgery is elective";"parents are not hospital staff. Exclusion criteria: "surgery to be canceled";"the patient does not refer to hospital for surgery on the day of surgery";"polygraph questionnaire scores Children's Manifest Anxiety Scale more than 20%";"unwillingness children and their parents at each stage of research. Sampling was non-probability available, distributed in four groups will be randomly. In the first group after doctor's visit, educational film displayed with descriptions nurse. The second group only educational film displayed without nurse. In the third group on the morning of the surgery day educational film displayed with descriptions nurse. In fourth group on the morning of the surgery day only educational film displayed. To measure the level of anxiety in children of Children's Manifest Anxiety Scale (RCMAS) and anxiety for parents was used Spielberger state-trait anxiety inventory (STAI) on two occasions, first time before the intervention and the second time before entering the operating room was completed.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016091829798N2
Registration date:2016-12-27, 1395/10/07
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-12-27, 1395/10/07
Registrant information
Name
Malihe Shoja
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 915 520 0415
Email address
shojam2@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Mashhad University of Medical Sciences
Expected recruitment start date
2016-08-22, 1395/06/01
Expected recruitment end date
2016-11-20, 1395/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of preoperative preparation program with different method and time on anxiety of school-age children and parents: factorial design
Public title
The effect of preoperative preparation program on anxiety of school-age children and parents
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria include: "The children ranged from 6 to 12 years";"pediatric surgery as apply on day care unit (hospitalization up to 1 day";"Speech, vision and hearing well";"do not have psychological disease";"children are not single parent";"children did not have surgery before";"surgery is elective";"parents are not hospital staff. Exclusion criteria: "surgery to be canceled";"the patient does not refer to hospital for surgery on the day of surgery";"polygraph questionnaire scores Children's Manifest Anxiety Scale more than 20%";"unwillingness children and their parents at each stage of research.
Age
From 6 years old to 12 years old
Gender
Both
Phase
2-3
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
Factorial
Other design features
In this study, preoperative preparation program consists of training that is provided with educational videos, interviews, questions and answers for sick children and their parents. Training video is 8 minutes and includes all steps that will follow children from the time of referral to admission, enter the surgical ward and admission, preparing children for surgery include change dressing, transfer to the operation room and anesthesia and then the recovery, meet their parents, transfer to ward. The program was conducted in two methods with or without explanations nurse and two different times before and the day of surgery. Training was teaching team and each groups had 3-5 members. Sampling is available and non-probability, then were randomly distributed in to 4 groups. Allocation of sample in to different groups was stratified block. Based on the patient training in ward or clinic were divided into two classes, then for each class separately using a random list of four blocks. In this method, showing educational film with description nurse with A and showing educational film without description nurse with B. Block quadruple meaning that of every four patients. Two patients are in A, two patients are in B.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences.
Street address
Knowledge and Health City – In the end of Shahid Fakouri Blvd. – Mashhad - Iran
City
Mashhad
Postal code
99191-91778
Approval date
2016-06-01, 1395/03/12
Ethics committee reference number
IR.MUMS.REC.1395.122
Health conditions studied
1
Description of health condition studied
anxiety
ICD-10 code
F41.1
ICD-10 code description
Generalized anxiety disorder
Primary outcomes
1
Description
Anxiety in children and their parents
Timepoint
Assess the level of anxiety of children and their parents in two occasions, the first time before training and watching film and the second time before admission children in the operating room.
Method of measurement
Using the RCMAS in children and Spielbergerfor in parents
Secondary outcomes
empty
Intervention groups
1
Description
Intervention1. In the clinic and after doctor's visits, educational film displayed with descriptions nurse and after viewing the film was answered questions from children and parents.
Category
Behavior
2
Description
Intervention4. In the morning of the surgery day only educational film displayed without nurse.
Category
Behavior
3
Description
Intervention2. In the clinic and after doctor's visits, educational film displayed without nurse.
Category
Behavior
4
Description
Intervention3. In the morning of surgery day educational film displayed with descriptions nurse and after viewing the film was answered questions from children and parents.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Doctor Sheikh Hospital
Full name of responsible person
Malihe Shoja
Street address
Doctor Sheikh street
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Mashhad University of Medical Sciences
Full name of responsible person
Doctor Saeed Eslami
Street address
University St., Ghoraishy Building
City
Mashhad
Grant name
Grant code / Reference number
941519
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Malihe Shoja
Position
MSC of Nursing
Other areas of specialty/work
Street address
Doctor Sheikh Hospital
City
Mashhad
Postal code
91735-1358
Phone
+98 51 3723 6690
Fax
+98 51 3727 7470
Email
shojam2@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
School of Nursing and Midwifery
Full name of responsible person
Doctor Fatemeh Heshmati Nabavi
Position
PHD of Nursing
Other areas of specialty/work
Street address
Ibn-e Sina St., Chaharah Doktora Crossing
City
Mashhad
Postal code
9137913199
Phone
+98 51 3859 8016
Fax
+98 51 3859 7313
Email
heshmatinf@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Malihe Shoja
Position
MSC of Nursing
Other areas of specialty/work
Street address
Doctor Sheikh Hospital
City
Mashhad
Postal code
91735-1358
Phone
+98 51 3726 9021
Fax
+98 51 3727 7470
Email
shojam2@mums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)