The effect of robotic training on mother-child relationships and anxiety in children hospitilized
Design
Clinical trial with control and intervention group, sampling was based on purposeful and accessible, and by simple random method, 15 appointment children in the first group as an intervention group and 15 patients in the next group as control group, without substitution, December 2018 to October 2019 and followed for one month later
Settings and conduct
Robotics training sessions during 8 sessions in two weeks on improving child-parent relationship and anxiety in hospitalized children in a semi-experimental pre and post test in two groups of intervention and control in the pediatric ward of Shahid Motahari Hospital affiliated to Urmia University of Medical Science will be done in 2018.
Participants/Inclusion and exclusion criteria
Age
Intervention groups
The intervention group will receive robotic training sessions next to mothers in 8 sessions of 1 hour during the first two weeks of admission.
Main outcome variables
Mother-child relationships, Anxiety in hospitalized children
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181022041419N1
Registration date:2018-12-24, 1397/10/03
Registration timing:registered_while_recruiting
Last update:2018-12-24, 1397/10/03
Update count:1
Registration date
2018-12-24, 1397/10/03
Registrant information
Name
Sima Pourteimour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 44 3338 7708
Email address
simapure@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-12-22, 1397/10/01
Expected recruitment end date
2019-04-21, 1398/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of robotic training play on the mother-child relationship and stress of children hodpitilized in hospital
Public title
The effect of robotic training play on the mother-child relationship and stress of children hodpitilized in Shahid Motahari Educational Centers of Urmia in 2018
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
The age of mothers over the age of 18 years is to be satisfied with the presence of the research.
Mother must have hospitalized child.
The mother is able to communicate in a different language.
The mother has literacy to read and write.
Mothers and children must be native to Orumiyeh city for the purpose of going to the outpatient clinic and performing the intervention and have a readiness and ability to visit one month later to follow up.
During the time of admission, be sure the mother and the child are present for 60 minutes at the time of the game.
The child has no educational background about the robotic training game.
The child should have at least one week of hospitalization.
A child with neurological diseases, such as seizures, mental and mental disabilities, mental problems, and history of taking fluids such as anxiolytics, are not based on a doctor's diagnosis and a child's medical record. Child ages 5 to 7 years.
Exclusion criteria:
Parental dissatisfaction for participation in the study.
Missing children participating in more than two sessions of the robotics training program.
Use of drugs that reduce children's anxiety and fear.
Age
From 4 years old to 7 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Random method and description of each method: simple randomization.
Random unit: Individual.
Randomization Tool: Random Numbers.
How to create a random sequence: In order to prevent the possibility of interference between robotic training games in groups, each group of at least 5 people will be sampled randomly in a two week interval.
Explaining Hiding: The first groups will be the intervention group. Next groups will be selected as non-interventional controls.
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
Urmia university of meducal science
Street address
Kashani Ave., Motahari Hospital, Urmia city
City
Urmia
Province
West Azarbaijan
Postal code
5718673533
Approval date
2018-09-21, 1397/06/30
Ethics committee reference number
IR.UMSU.REC.1397.145
Health conditions studied
1
Description of health condition studied
hospitalized Children
ICD-10 code
F43.2
ICD-10 code description
Adjustment disorders
Primary outcomes
1
Description
Average score of anxiety of hospitalized children
Timepoint
Before the intervention, immediately after the intervention and one month later
Method of measurement
Pre-school children's anxiety questionnaire of 28 items
Secondary outcomes
1
Description
Average score of mother-child relationship
Timepoint
Before the intervention, immediately after intervention, one month later
Method of measurement
Parent-parent relationship questionnaire of 33 items
Intervention groups
1
Description
Robotic training sessions (with the goals specified in each session) will be held for children admitted to mothers in 8 sessions of 1 hour in the evening shifts, during the two weeks of admission to the children's playroom of Motahari Hospital in Urmia, with use of 15 packages which produce from Robofa Iran Co. affiliated with Sharif University of Technology, named Robot Warrior. Educational information will also be provided in the form of pamphlets and educational CDs. The reason behind the use of this robot, according to a study by the Robotics Institutions, is the ultimate goal of making this robot an incentive to counteract the stresses and problems of children. In order to achieve the objectives of the plan, the 8 steps of the training session will be presented in the form of a structured structure.
Category
Other
2
Description
Control group: The routine nursing interventions of the children's department will be received.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Motahari Hospital in Urmia
Full name of responsible person
Sima Pourteimour
Street address
Motahari Hospital, Kashani Ave, Urmia
City
Urmia
Province
West Azarbaijan
Postal code
5718673533
Phone
+98 44 3275 4963
Email
simapure@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
ایرج محبی
Street address
Urmia Blvd. Mission Center Emergency Department Headquarters, University of Science and Technology Dept. of Research and Technology
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3193 7224
Email
mohebbi_iraj@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Oroumia 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
Oroumia University of Medical Sciences
Full name of responsible person
Sima Pourteimour
Position
faculty member
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Nazlou Campus Building Faculty of Nursing and Midwifery - 11 km Sero - Urmia - West Azarbaijan - Iran
City
Urmia
Province
West Azarbaijan
Postal code
5756115111
Phone
+98 44 3275 4963
Email
simapure@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Sima Pourteimour
Position
Faculty member
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Nazlou Campus Building Faculty of Nursing and Midwifery, 11 km Sero, Urmia, West Azarbaijan,Iran
City
Urmia
Province
West Azarbaijan
Postal code
5756115111
Phone
+98 44 3275 4963
Email
simapure@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Sima Pourteimour
Position
Faculty member
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Nazlou Campus Building Faculty of Nursing and Midwifery - 11 km Sero - Urmia - West Azarbaijan - Iran
City
Urmia
Province
West Azarbaijan
Postal code
5756115111
Phone
+98 44 3275 4963
Email
simapure@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
Only part of the information, such as information on the main outcome or the like, can be shared.
When the data will become available and for how long
6 months after publish results
To whom data/document is available
Researchers working in academia and academia
Under which criteria data/document could be used
After permission from the responsible author, any analysis may be possible.
From where data/document is obtainable
simapure@yahoo.com
Sima Pourteioumr
Faculty Member of Urmia Nursing and Midwifery Faculty
What processes are involved for a request to access data/document
Within a week of sending the email, the documentation will be available with the preservation of spirituality.