Protocol summary
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Study aim
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The effect of robotic training on mother-child relationships and anxiety in children hospitilized
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Design
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Clinical trial with control and intervention group, sampling was based on purposeful and accessible, and by non- 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
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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Age
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Intervention groups
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The intervention group will receive robotic training sessions next to mothers in 8 sessions of 1 hour during the first two weeks of admission.
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Main outcome variables
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Mother-child relationships, Anxiety in hospitalized children
General information
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Reason for update
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Due to the completion of sampling, in order to prevent the transfer of information from the intervention group to the control, data collection was done throuth the convenience sampling and non-random manner in two separate units (one pediatric unit for the intervention group and another unit for the control group).
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20181022041419N1
Registration date:
2018-12-24, 1397/10/03
Registration timing:
prospective
Last update:
2021-02-17, 1399/11/29
Update count:
1
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Registration date
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2018-12-24, 1397/10/03
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2018-12-22, 1397/10/01
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Expected recruitment end date
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2019-04-21, 1398/02/01
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Actual recruitment start date
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2019-02-01, 1397/11/12
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Actual recruitment end date
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2019-07-31, 1398/05/09
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Trial completion date
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2019-07-31, 1398/05/09
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Scientific title
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The effect of robotic training play on the mother-child relationship and stress of children hodpitilized in hospital
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Public title
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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
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Purpose
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Education/Guidance
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Inclusion/Exclusion criteria
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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 3 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.
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Age
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From 3 years old to 7 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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No information
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Sample size
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Target sample size:
60
Actual sample size reached:
59
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Randomization (investigator's opinion)
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Not randomized
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Randomization description
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2018-09-21, 1397/06/30
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Ethics committee reference number
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IR.UMSU.REC.1397.145
Health conditions studied
1
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Description of health condition studied
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hospitalized Children
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ICD-10 code
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F43.2
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ICD-10 code description
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Adjustment disorders
Primary outcomes
1
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Description
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Average score of anxiety of hospitalized children
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Timepoint
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Before the intervention, immediately after the intervention
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Method of measurement
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Pre-school children's anxiety questionnaire of 28 items
Secondary outcomes
1
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Description
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Average score of mother-child relationship
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Timepoint
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Before the intervention, immediately after intervention
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Method of measurement
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Parent-parent relationship questionnaire of 33 items
Intervention groups
1
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Description
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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 Motahari Hospital in Urmia, use of 59 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.
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Category
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Other
2
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Description
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Control group: The routine nursing interventions of the children's department will be received.
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Category
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Treatment - Other
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Oroumia University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Not applicable
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Not applicable
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Title and more details about the data/document
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Only part of the information, such as information on the main outcome or the like, can be shared.
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When the data will become available and for how long
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6 months after publish results
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To whom data/document is available
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Researchers working in academia and academia
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Under which criteria data/document could be used
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After permission from the responsible author, any analysis may be possible.
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From where data/document is obtainable
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simapure@yahoo.com
Sima Pourteioumr
Faculty Member of Urmia Nursing and Midwifery Faculty
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What processes are involved for a request to access data/document
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Within a week of sending the email, the documentation will be available with the preservation of spirituality.
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Comments
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