Compare the effect of Dress and Teddy Bear on the admission anxiety and fear child age 3-6 years old
Design
Seventy five children transferred from the emergency department to the pediatric ward. Qualified children were made unpredictable by choosing and distributing children to a group of Teddy Bear, Dress and control with simple random assignment. Data were collected by a questionnaire containing two parts. The first part was personal information, and the second part included a self-report tool for fear and anxiety.
Settings and conduct
This research was conducted in Imam Reza Hospital, Mashhad, Iran. Children from the emergency department were transferred to the pediatric ward during a phase. A researcher with Dress and Teddy Bear was in the process of admitting with the child at the same time. The Blind was one-sided, and the children were unaware of the results of the research. At the end, the child was placed in the bed and the anxiety and fear were measured by the self-report tool.
Participants/Inclusion and exclusion criteria
Qualifying children aged 3-6 years and not having chronic disease and anxiety, having no severe pain during the intervention.
Intervention groups
The Teddy Bear group was "Saturday and Sunday", The Dress group was "Monday and Tuesday," Dress and Teddy Bear program was for an hour such as featuring initial engagement: A researcher say hello with the child, The department and the Interventions were be recognized to the child. Accompaniment with the child will be continued and all procedures were initiated with the help of the researcher. In the final stage, the researcher takes the child to his room for placement on the bed, and afterwards the child score for the self-report tool and then researcher say goodbye to him. "The control group was" Wednesday and Thursday ".The researcher wears the normal uniform and then the child score the scale. " At the end, fear and anxiety were compared in control and intervention groups.
Main outcome variables
The study of child anxiety and fear at the end of the admission process using the self-report tool in all three groups.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160709028849N1
Registration date:2017-12-02, 1396/09/11
Registration timing:retrospective
Last update:2017-12-02, 1396/09/11
Update count:0
Registration date
2017-12-02, 1396/09/11
Registrant information
Name
Farzaneh Abbasian
Name of organization / entity
Mashhad University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 915 762 2264
Email address
abbasianf931@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Governmental
Expected recruitment start date
2016-07-22, 1395/05/01
Expected recruitment end date
2016-10-22, 1395/08/01
Actual recruitment start date
2016-07-22, 1395/05/01
Actual recruitment end date
2016-10-22, 1395/08/01
Trial completion date
empty
Scientific title
The effect of the Dress and Doll clothes on the anxiety and fear child
Public title
The effect of the Dress and Doll clothes on the anxiety and fear child
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Have informed consent to participate in the intervention
Has been moved from Hospital emergency department of Imam Reza to the pediatric ward
One of the parents has been present
Is not have growth and mental retardation
Is not suffering from chronic diseases
Is not suffering from separation anxiety and phobia
Has not severe pain before intervention
Parents not associated with hospital staff
The child' age is 6-3 years
Anti-anxiety medication is not used
Exclusion criteria:
Do not want to continue research for any reason
Children requiring emergency intervention
Pain during the intervention
Age
From 3 years old to 6 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
75
Actual sample size reached:
75
Randomization (investigator's opinion)
Randomized
Randomization description
The groups randomly assigned two days each week using random numbers. Teddy Bear group was specially assign to on Saturday and Sunday. Dress group was specially assign to on Monday and Tuesday and the control group was specially assign to on Wednesday and Thursday, and then the children arrived in the group on the basis of arrival each day.
Blinding (investigator's opinion)
Single blinded
Blinding description
After obtaining consent from the parents of children, interventions were carried out and children were enrolled in the study and at the end they scored the self-report instrument. Children only chose the shape in the video self-monitoring tool that was close to their state of affairs and was unaware of its impact on the results of the research.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Mashhad University of Science
Street address
Faculty of Nursing and Midwifery, Ibn Sina Avenue, Doctora Square, Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
99191-91778
Approval date
2016-06-20, 1395/03/31
Ethics committee reference number
IR.MUMS.REC.1395.163
Health conditions studied
1
Description of health condition studied
Anxiety and Fear of admitting children
ICD-10 code
F40-F48
ICD-10 code description
Neurotic, stress-related and somatoform disorders
Primary outcomes
1
Description
Fear
Timepoint
After intervention
Method of measurement
Fear self report
Secondary outcomes
1
Description
Anxiety
Timepoint
After intervention
Method of measurement
Anxiety self-report scale
Intervention groups
1
Description
"Control group: Nurse using form dressing
white is from the child's admission to staying with her on the bed. "
Category
N/A
2
Description
"Intervention group: A nurse with a Teddy Bear will do all the work at the child's reception, and until he stays with him on the bed."
Category
N/A
3
Description
"Intervention group: A nurse with a colorful dress will do all the work for the child and she will be with her on the bed"
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Vazifedust
Street address
Ibn Sina Ave, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9919191778
Phone
+98 51 3841 3007
Fax
+98 51 3841 3006
Email
Abbasianf931@mums.ac.ir
Web page address
http://www.mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Saeed Islami
Street address
Faculty of Nursing and Midwifery, Ibn Sina Avenue, Doctora Square, Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
13944-91388
Phone
+98 51 3841 3007
Fax
+98 51 3871 3638
Email
s.eslami@amc.uva.nl
Web page address
http://www.mums.ac.ir
Grant name
941825
Grant code / Reference number
IR.MUMS.REC.1395.163
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Farzaneh Abbasian
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery, Ibn Sina Avenue, Doctora Square, Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Fax
+98 51 3859 7313
Email
nms.it@mums.ac.ir
Web page address
http://www.mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Tayebeh Reihani
Position
Teacher
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery, Ibn Sina Avenue, Doctora Square, Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Fax
+98 51 3859 7313
Email
nums.it@mums.ac.ir
Web page address
http://www.mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Farzaneh Abbasian
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery, Ibn Sina Avenue, Doctora Square, Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Fax
+98 51 3859 7313
Email
Abbasianf931@mums.ac.ir
Web page address
http://www.mums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available