1. Home
  2. Approved trials
  3. » فارسی

The effect of robotic training play on the mother-child relationship and stress of children hodpitilized in hospital

View the latest revision

History
# Registration date Revision Id
2 2021-02-16, 1399/11/28 171588
1 2018-12-24, 1397/10/03 72024
Changes made to previous revision

  • Help:

    Red color represents old content. It may be empty showing addition in the new version.
    Green color represents new content. It may be empty showing deletion in the new version.

    Inline Side by side
    Added new contents, deleted old contents, contents that are not changed.
    New table contents New table contents
    Old table contents Old table contents
    Unchanged contents Unchanged contents
    Added new contents, contents that are not changed.
    Deleted old contents, contents that are not changed.
    Old table contents Old table contents
    Unchanged contents Unchanged contents
    New table contents New table contents
    Unchanged contents Unchanged contents

  • Protocol summary

    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
    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
    کارآزمایی بالینی دارای گروه کنترل و مداخله، نمونه گیری به صورت مبتنی بر هدف و در دسترس انتخاب و با روش تصادفی ساده 15 کودک انتصاب در گروه اول به عنوان گروه مداخله و15 نفر هم در گروه بعدی بعنوان گروه کنترل، بدون سو کوری، از دی ماه 1397 تا اردیبهشت 1398و یک ماه بعد پیگیری
    کارآزمایی بالینی دارای گروه کنترل و مداخله، نمونه گیری به صورت مبتنی بر هدف و در دسترس انتخاب و با روش غیرتصادفی 15 کودک انتصاب در گروه اول به عنوان گروه مداخله و15 نفر هم در گروه بعدی بعنوان گروه کنترل، بدون سو کوری، از دی ماه 1397 تا اردیبهشت 1398و یک ماه بعد پیگیری

  • General information

    4
    3
    Randomized
    Not randomized
    30
    60
    empty
    59
    empty
    2019-02-01, 1397/11/12
    empty
    2019-07-31, 1398/05/09
    empty
    2019-07-31, 1398/05/09
    empty
    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).
    empty
    با توجه به اتمام نمونه گیری، به دلیل پیشگیری از انتقال اطلاعات از گروه مداخله به کنترل نمونه گیری به صورت در دسترس و غیر تصادفی در دو بخش جداگانه (یک بخش برای گروه مداخله و یک بخش دیگر برای گروه کنترل)صورت گرفت.
    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.
    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.
    سن مادران بالاتر از 18 سال باشد و رضایت حضور در پژوهش را داشته باشد. مادر حتما کودک بستری در بیمارستان داشته باشد. مادر قادر به برقراری ارتباط در صورت زبان متفاوت باشد. مادر سواد خواندن و نوشتن داشته باشد. مادران و کودکان حتما بومی شهر ارومیه جهت لزوم مراجعه سرپایی و اجرای مداخله باشند و اعلام آمادگی و توانایی جهت مراجعه یک ماه بعد برای پیگیری را داشته باشند. در طی زمان بستری حتما مادر به همراه کودک به مدت 60 دقیقه در زمان اجرای بازی حضور داشته باشد. کودک سابقه آموزشی در مورد بازی آموزشی رباتیک نداشته باشد. مدت بستری کودک حداقل یک هفته باشد.کودک دچار بیماری های عصبی مانند انواع تشنج، ناتوانی های حرکتی و ذهنی، مشکلات روانی و سابقه مصرف داروهای روان مانند ضد اضطراب بر اساس تشخیص پزشک و پرونده پزشکی کودک نباشند. کودک در سن بین 5 سال تا 7 سال باشد.
    سن مادران بالاتر از 18 سال باشد و رضایت حضور در پژوهش را داشته باشد. مادر حتما کودک بستری در بیمارستان داشته باشد. مادر قادر به برقراری ارتباط در صورت زبان متفاوت باشد. مادر سواد خواندن و نوشتن داشته باشد. مادران و کودکان حتما بومی شهر ارومیه جهت لزوم مراجعه سرپایی و اجرای مداخله باشند و اعلام آمادگی و توانایی جهت مراجعه یک ماه بعد برای پیگیری را داشته باشند. در طی زمان بستری حتما مادر به همراه کودک به مدت 60 دقیقه در زمان اجرای بازی حضور داشته باشد. کودک سابقه آموزشی در مورد بازی آموزشی رباتیک نداشته باشد. مدت بستری کودک حداقل یک هفته باشد.کودک دچار بیماری های عصبی مانند انواع تشنج، ناتوانی های حرکتی و ذهنی، مشکلات روانی و سابقه مصرف داروهای روان مانند ضد اضطراب بر اساس تشخیص پزشک و پرونده پزشکی کودک نباشند. کودک در سن بین 3 سال تا 7 سال باشد.
    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.
    .روش تصادفی سازی و توضیحات هر روش: تصادفی سازی ساده واحد تصادفی سازی: فردی ابزار تصادفی سازی: جدول اعداد تصادفی نحوه ساخت توالی تصادفی: به منظور پيشگيري از امكان تداخل بازی آموزشی رباتیک در گروه ها، هر گروه شامل حداقل 5 نفره با فاصله دو هفته به صورت تخصيص تصادفي نمونه گیری خواهند شد. توضیح درباره پنهان سازی : گروه های اول به عنوان گروه مداخله خواهد بود. بعد گروه های بعد بعنوان کنترل بدون مداخله انتخاب خواهند شد.

  • Primary outcomes

    #1
    Before the intervention, immediately after the intervention and one month later
    Before the intervention, immediately after the intervention
    قبل از مداخله، بلافاصله بعد از مداخله و یک ماه بعد
    قبل از مداخله، بلافاصله بعد از مداخله

  • Secondary outcomes

    #1
    Before the intervention, immediately after intervention, one month later
    Before the intervention, immediately after intervention
    قبل از مداخله، بلافاصله بعد مداخله، یک ماه بعد
    قبل از مداخله، بلافاصله بعد مداخله

  • Intervention groups

    #1
    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.
    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.
    جلسات بازی اموزشی رباتیک (با اهداف مشخص شده در هر جلسه) برای کودکان بستری انتخاب شده بر اساس معیار ورود به پژوهش و تصادفی در کنار مادران در 8 جلسه 1 ساعتی در شیفت عصر در طی دو هفته بستری در اتاق بازی کودکان بخش بستری بیمارستان مطهری ارومیه، با استفاده از تعداد ۱۵ بسته تهیه شده از شرکت روبوفای ایران وابسته به دانشگاه صنعتی شریف با نام ربات جنگجو خواهد بود.اطلاعات آموزشی در قالب جزوه ها و CD آموزشی در اختیار آنها نیز قرار خواهد گرفت. دلیل استفاده از این ربات طبق بررسی و صحبت با موسسات رباتیک هدف نهایی ساخت این ربات رسیدن به انگیزه مقاوت در برابر مشکلات و استرس های موجود در زندگی کودکان می باشد. براي دستيابي به اهداف طرح، مراحل 8 جلسه آموزشی در قالب يك ساختار منظم ارايه خواهد شد.
    جلسات بازی اموزشی رباتیک (با اهداف مشخص شده در هر جلسه) برای کودکان بستری انتخاب شده بر اساس معیار ورود به پژوهش و تصادفی در کنار مادران در 8 جلسه 1 ساعتی در شیفت عصر در طی دو هفته بستری در اتاق بازی کودکان بخش بستری بیمارستان مطهری ارومیه، با استفاده از تعداد 59 بسته تهیه شده از شرکت روبوفای ایران وابسته به دانشگاه صنعتی شریف با نام ربات جنگجو خواهد بود.اطلاعات آموزشی در قالب جزوه ها و CD آموزشی در اختیار آنها نیز قرار خواهد گرفت. دلیل استفاده از این ربات طبق بررسی و صحبت با موسسات رباتیک هدف نهایی ساخت این ربات رسیدن به انگیزه مقاوت در برابر مشکلات و استرس های موجود در زندگی کودکان می باشد. براي دستيابي به اهداف طرح، مراحل 8 جلسه آموزشی در قالب يك ساختار منظم ارايه خواهد شد.

  • Sponsors / Funding sources

    #1

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: ایرج محبی
    Full name of responsible person - Persian: Dr. Iraj Mohebi
    Street address - English: Urmia Blvd. Mission Center Emergency Department Headquarters, University of Science and Technology Dept. of Research and Technology
    Street address - Persian: ارومیه بلوار رسالت انتهای کوی اورژانس ستاد دانشگاه ساختمان معاونت تحقیقات و فناوری
    City - English: Urmia
    City - Persian: ارومیه
    Province: West Azarbaijan
    Country: Iran (Islamic Republic of)
    Postal code: 5714783734
    Phone: +98 44 3193 7224
    Fax:
    Email: mohebbi_iraj@yahoo.com
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Dr. Iraj Mohebi
    Full name of responsible person - Persian: ایرج محبی
    Street address - English: Research and Technology Department, Headquarters University, Emergency cuticle end, Resalat Blvd,Urmia
    Street address - Persian: ارومیه، بلوار رسالت، انتهای کوی اورژانس، ستاد دانشگاه، ساختمان معاونت تحقیقات و فناوری
    City - English: Urmia
    City - Persian: ارومیه
    Province: West Azarbaijan
    Country: Iran (Islamic Republic of)
    Postal code: 5714783734
    Phone: +98 44 3193 7224
    Fax:
    Email: mohebbi_iraj@yahoo.com
    Web page address:

Protocol summary

Study aim
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 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
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
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).
Acronym
IRCT registration information
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
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
2019-02-01, 1397/11/12
Actual recruitment end date
2019-07-31, 1398/05/09
Trial completion date
2019-07-31, 1398/05/09
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 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.
Age
From 3 years old to 7 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
Actual sample size reached: 59
Randomization (investigator's opinion)
Not randomized
Randomization description
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
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
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 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.
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
Dr. Iraj Mohebi
Street address
Research and Technology Department, Headquarters University, Emergency cuticle end, Resalat Blvd,Urmia
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.
Comments
Loading...