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Comparison of the effect of two methods of active Distraction based on computer games and Inactive Distraction based on playing music on anxiety and physiological indicators of removing the cast in children aged 8 to 12 years

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History
# Registration date Revision Id
3 2025-09-30, 1404/07/08 357192
2 2025-01-30, 1403/11/11 329658
1 2020-10-09, 1399/07/18 154065
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  • Protocol summary

    Respiration rate, heart rate, arterial blood oxygen saturation and anxiety in children were determined 5 minutes before and immediately before the intervention and the average of these two measurements was recorded as a score before the intervention; Also, the average of the measurements immediately after the intervention and 5 minutes after the intervention is considered as the score after the intervention.
    Respiratory rate, heart rate, and children's anxiety levels are recorded before and after the intervention. The research participants are selected from children requiring cast removal at Valiasr Hospital in Arak.
    تعداد تنفس, تعداد ضربان قلب، درصد اشباع اکسیژن خون شریانی(SPO2) و اضطراب کودکان ۵ دقیقه قبل و بلافاصله قبل از انجام مداخله تعیین و میانگین این دو اندازه گیری، به عنوان نمره قبل از مداخله ثبت می گردد؛ همچنین میانگین اندازه گیری های بلافاصله بعد از مداخله و 5 دقیقه بعد از مداخله به عنوان نمره بعد از مداخله در نظر گرفته می شود. انتخاب واحدهای پژوهش از میان کودکان نیازمند باز کردن گچ مراجعه کننده به بیمارستان ولیعصر شهر اراک صورت می گیرد.
    تعداد تنفس, تعداد ضربان قلب و اضطراب کودکان قبل و بعد از انجام مداخله، ثبت می گردد؛ انتخاب واحدهای پژوهش از میان کودکان نیازمند باز کردن گچ مراجعه کننده به بیمارستان ولیعصر شهر اراک صورت می گیرد.
    Intervention group 1: Playing children's music appropriate to the age, gender and interest of children, from 5 minutes before and 5 minutes after removing the cast through wireless headphones; Intervention group 2: selecting and performing computer games, from 5 minutes before to 2 minutes after cast removal, via tablet; Control group: no intervention
    Intervention group 1: Playing children's music appropriate to the age, gender and interest of children, from 5 minutes before and 2 minutes after removing the cast through wireless headphones; Intervention group 2: selecting and performing computer games, from 5 minutes before to 2 minutes after cast removal, via tablet; Control group: no intervention
    گروه مداخله1: پخش موسیقی های کودکانه متناسب با سن، جنس و علاقه کودکان، از 5 دقیقه قبل تا 5 دقیقه بعد از برش گچ از طریق هدفون وایرلس؛ گروه مداخله2: انتخاب و انجام بازی های رایانه ای متناسب با سن، جنس و علاقه کودکان از 5 دقیقه قبل و 2 دقیقه بعد از برش گچ، از طریق تبلت؛ گروه کنترل: عدم مداخله
    گروه مداخله1: پخش موسیقی های کودکانه متناسب با سن، جنس و علاقه کودکان، از 5 دقیقه قبل تا 2 دقیقه بعد از برش گچ از طریق هدفون وایرلس؛ گروه مداخله2: انتخاب و انجام بازی های رایانه ای متناسب با سن، جنس و علاقه کودکان از 5 دقیقه قبل و 2 دقیقه بعد از برش گچ، از طریق تبلت؛ گروه کنترل: عدم مداخله
    Respiratory rate,; heart rate; arterial blood oxygen saturation and anxiety
    Respiratory rate; heart rate and anxiety
    تعداد تنفس, تعداد ضربان قلب، درصد اشباع اکسیژن خون شریانی(SPO2) و اضطراب
    تعداد تنفس, تعداد ضربان قلب و اضطراب

  • General information

    empty
    Study protocol update
    empty
    به روز رسانی پروتکل مطالعه
    The selection of research units was done through available (easy) sampling method among children volunteer to removing the cast referral to Valiasr Hospital in Arak, then these children are divided, by random permutation block method, into three equal members groups; Intervention 1 (active Distraction based on computer games), intervention 2 (Inactive Distraction based on playing music) and the control group.
    The research participants are selected using a convenience sampling method from children requiring cast removal at Valiasr Hospital in Arak. They are then randomly assigned in equal numbers to three groups; Intervention 1 (passive distraction with music), Intervention 2 (active distraction with video games), and the control group, using block randomization with software. These groups undergo a clinical trial.
    انتخاب واحد های پژوهش از طریق روش نمونه گیری در دسترس(آسان) از میان کودکان نیازمند باز کردن گچ مراجعه کننده به بیمارستان ولیعصر شهر اراک صورت می گیرد. سپس این کودکان به روش بلوک جایگشت تصادفی با استفاده از نرم افزار Random Allocation به تعداد اعضای برابر در سه گروه مداخله 1(انحراف فکر غیر فعال مبتنی بر پخش موسیقی)، مداخله 2 (انحراف فکر فعال مبتنی بر بازی های رایانه ای) و گروه کنترل تقسیم شده و مورد آزمون بالینی قرار می گیرند.
    انتخاب واحد های پژوهش از طریق روش نمونه گیری در دسترس از میان کودکان نیازمند باز کردن گچ مراجعه کننده به بیمارستان ولیعصر شهر اراک صورت می گیرد. سپس این کودکان به روش بلوک جایگشت تصادفی با استفاده از نرم افزار به تعداد اعضای برابر در سه گروه مداخله 1(انحراف فکر غیر فعال مبتنی بر پخش موسیقی)، مداخله 2 (انحراف فکر فعال مبتنی بر بازی های رایانه ای) و گروه کنترل تقسیم شده و مورد آزمون بالینی قرار می گیرند.

  • Primary outcomes

    #1
    Before intervention, immediately before intervention and after intervention
    Before intervention and after intervention
    قبل از مداخله، بلافاصله قبل از مداخله و بعد از مداخله
    قبل از مداخله و بعد از مداخله
    #2
    5 minutes before the intervention, immediately before the intervention, immediately after the intervention, 5 minutes after the intervention
    Immediately before the intervention, after the intervention
    5 دقیقه قبل از مداخله، بلافاصله قبل مداخله، بلافاصله بعد از مداخله، 5 دقیقه بعد از مداخله
    بلافاصله قبل مداخله، بعد از مداخله
    #3
    Arterial blood oxygen saturation (SPO2)
    Respiratory rate
    درصد اشباع اکسیژن خون شریانی(SPO2)
    تنفس
    5 minutes before the intervention, immediately before the intervention, immediately after the intervention, 5 minutes after the intervention
    Immediately before the intervention, after the intervention
    ۵ دقیقه قبل از مداخله، بلافاصله قبل مداخله، بلافاصله بعد از مداخله، 5 دقیقه بعد از مداخله
    بلافاصله قبل مداخله، بعد از مداخله
    Percentage - pulse oximeter
    Count per minute - count breathing by observation
    درصد - دستگاه پالس اكسي متری
    تعداد در دقیقه - شمارش تنفس از طریق مشاهده
    #4
    Respiratory rate
    Anxiety
    تنفس
    اضطراب
    5 minutes before the intervention, immediately before the intervention, immediately after the intervention, 5 minutes after the intervention
    Before intervention and after intervention
    ۵ دقیقه قبل از مداخله، بلافاصله قبل مداخله، بلافاصله بعد از مداخله، 5 دقیقه بعد از مداخله
    قبل از مداخله و بعد از مداخله
    Count per minute - count breathing by observation
    Facial Anxiety Scale
    تعداد در دقیقه - شمارش تنفس از طریق مشاهده
    مقیاس چهره ای اضطراب

  • Intervention groups

    #1
    گروه مداخله1: انحراف فکر غیر فعال مبتنی بر پخش موسیقی، کودکان در این گروه، چند دقیقه قبل از شروع برشِ گچ به همراه پژوهشگر و یک یا هر دو والد خود به اتاق گچ رفته، و پژوهشگر کودک را با محیط و وسایل اتاق گچ آشنا می کند. تا عامل استرسِ عدم آشنایی، سبب بروز تداخلی در اندازه‌گیری‌ها نشود. سپس از 5 دقیقه قبل از برش گچ و در طول پروسیجر و همچنین 5 دقیقه بعد از بازکردن گچ، موسیقی متناسب با سن، جنس و علاقه کودک انتخاب و پخش می گردد. موسیقی های مورد استفاده همگی دارایِ ضرب آهنگ 80-60 ضربه در ثانیه و بلندی صدای 40 تا 50 دسی‌بل بوده و همه آنها دارای ریتم و گردش های ملودیک آرام و یکنواخت بوده و نیز هیچ یک از آنها محرک، غم انگیز و یا هیجان آور نمی باشند. پخش موسیقی متناسب با شرایطِ هر کودک از طریق هدفونِ وایرلس صورت می گیرد.
    گروه مداخله1: انحراف فکر غیر فعال مبتنی بر پخش موسیقی، کودکان در این گروه، چند دقیقه قبل از شروع برشِ گچ به همراه پژوهشگر و یک یا هر دو والد خود به اتاق گچ رفته، و پژوهشگر کودک را با محیط و وسایل اتاق گچ آشنا می کند. تا عامل استرسِ عدم آشنایی، سبب بروز تداخلی در اندازه‌گیری‌ها نشود. سپس از 5 دقیقه قبل از برش گچ و در طول پروسیجر و همچنین 2 دقیقه بعد از بازکردن گچ، موسیقی متناسب با سن، جنس و علاقه کودک انتخاب و پخش می گردد. موسیقی های مورد استفاده همگی دارایِ ضرب آهنگ 80-60 ضربه در ثانیه و بلندی صدای 40 تا 50 دسی‌بل بوده و همه آنها دارای ریتم و گردش های ملودیک آرام و یکنواخت بوده و نیز هیچ یک از آنها محرک، غم انگیز و یا هیجان آور نمی باشند. پخش موسیقی متناسب با شرایطِ هر کودک از طریق هدفونِ وایرلس صورت می گیرد.
    #2
    گروه مداخله2: انحراف فکر فعال مبتنی بر بازی های رایانه ای، کودکان در این گروه چند دقیقه قبل از شروع برشِ گچ به همراه پژوهشگر و یک یا هر دو والد خود به اتاق گچ رفته، و پژوهشگر کودک را با محیط و وسایل اتاق گچ آشنا می کند. تا عامل استرسِ عدم آشنایی، سبب بروز تداخلی در اندازه‌گیری‌ها نشود. سپس از 5 دقیقه قبل از برش گچ و در طول پروسیجر و همچنین 5 دقیقه بعد از بازکردن گچ، بازی رایانه ای متناسب با سن، جنس و علاقه خود از طریق تبلت انجام خواهند داد.
    گروه مداخله2: انحراف فکر فعال مبتنی بر بازی های رایانه ای، کودکان در این گروه چند دقیقه قبل از شروع برشِ گچ به همراه پژوهشگر و یک یا هر دو والد خود به اتاق گچ رفته، و پژوهشگر کودک را با محیط و وسایل اتاق گچ آشنا می کند. تا عامل استرسِ عدم آشنایی، سبب بروز تداخلی در اندازه‌گیری‌ها نشود. سپس از 5 دقیقه قبل از برش گچ و در طول پروسیجر و همچنین 2 دقیقه بعد از بازکردن گچ، بازی رایانه ای متناسب با سن، جنس و علاقه خود از طریق تبلت انجام خواهند داد.
    #3
    گروه کنترل: کودکان در این گروه هیچ گونه مداخله ای را دریافت نکرده و برش گچ به صورت معمول انجام خواهد.
    گروه کنترل: کودکان در این گروه هیچ گونه مداخله ای را دریافت نکرده و برش گچ به صورت معمول انجام خواهد شد.

  • Recruitment centers

    #1
    Name of recruitment center - English: Valiasr Hospital of Arak
    Name of recruitment center - Persian: بیمارستان ولیعصر اراک
    Full name of responsible person - English: Ali Safdari
    Full name of responsible person - Persian: علی صفدری
    Street address - English: No. Arak, Valiasr Hospital
    Street address - Persian: اراک، بیمارستان ولیعصر
    City - English: Arak
    City - Persian: اراک
    Province: Markazi
    Country: Iran (Islamic Republic of)
    Postal code: 3848176941
    Phone: +98 86 3417 3505
    Fax:
    Email: asafdari.nu@gmail.com
    Web page address:
    Name of recruitment center - English: Valiasr Hospital of Arak
    Name of recruitment center - Persian: بیمارستان ولیعصر اراک
    Full name of responsible person - English: Ali Safdari
    Full name of responsible person - Persian: علی صفدری
    Street address - English: Valiasr Hospital, Valiasr squre, Shahid Shirodi street
    Street address - Persian: اراک، میدان ولیعصر، خیابان شهید شیرودی، بیمارستان ولیعصر
    City - English: Arak
    City - Persian: اراک
    Province: Markazi
    Country: Iran (Islamic Republic of)
    Postal code: 3848176941
    Phone: +98 86 3417 3505
    Fax:
    Email: asafdari.nu@gmail.com
    Web page address:

  • Sponsors / Funding sources

    #1

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Alireza Kamali
    Full name of responsible person - Persian: علیرضا کمالی
    Street address - English: No. Arak, Sardasht, Basij Square, Arak University of Medical Sciences
    Street address - Persian: اراک، سردشت، میدان بسیج، دانشگاه علوم پزشکی اراک
    City - English: Arak
    City - Persian: اراک
    Province: Markazi
    Country: Iran (Islamic Republic of)
    Postal code: 3848176941
    Phone: +98 86 3417 3505
    Fax:
    Email: alikamaliir@yahoo.com
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Alireza Kamali
    Full name of responsible person - Persian: علیرضا کمالی
    Street address - English: Arak University of Medical Sciences, Sardasht, Basij Square
    Street address - Persian: اراک، سردشت، میدان بسیج، دانشگاه علوم پزشکی اراک
    City - English: Arak
    City - Persian: اراک
    Province: Markazi
    Country: Iran (Islamic Republic of)
    Postal code: 3848176941
    Phone: +98 86 3417 3505
    Fax:
    Email: alikamaliir@yahoo.com
    Web page address:

Protocol summary

Study aim
In this study, the effect of two methods of active distraction based on computer games and inactive distraction based on playing music on anxiety and physiological indicators of removing the cast in children aged 8 to 12 years is investigated.
Design
In this clinical trial study, 105 children between the ages of 8 to 12 years needed to removing the cast through a random permutation block with an equal number of members in three groups: intervention 1 (music playing), intervention 2 (do playing), and group controls, are clinically tested.
Settings and conduct
Respiratory rate, heart rate, and children's anxiety levels are recorded before and after the intervention. The research participants are selected from children requiring cast removal at Valiasr Hospital in Arak.
Participants/Inclusion and exclusion criteria
Willingness to participant to study by parents and the child; age over 8 years and under 12 years old; having plaster on the upper or lower limbs; the ability to speak and understand Persian; not take sedative or analgesic drugs for one hour before cast removal; lack of hearing and vision problems, mental illness, speech disorders and mental retardation, hyperactivity; lack of compartment syndrome
Intervention groups
Intervention group 1: Playing children's music appropriate to the age, gender and interest of children, from 5 minutes before and 2 minutes after removing the cast through wireless headphones; Intervention group 2: selecting and performing computer games, from 5 minutes before to 2 minutes after cast removal, via tablet; Control group: no intervention
Main outcome variables
Respiratory rate; heart rate and anxiety

General information

Reason for update
Study protocol update
Acronym
IRCT registration information
IRCT registration number: IRCT20180523039793N2
Registration date: 2020-10-09, 1399/07/18
Registration timing: prospective

Last update: 2025-02-05, 1403/11/17
Update count: 2
Registration date
2020-10-09, 1399/07/18
Registrant information
Name
Razieh Mokhtari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 3277 7971
Email address
razieh.mokhtari91@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-10-31, 1399/08/10
Expected recruitment end date
2021-01-29, 1399/11/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of two methods of active Distraction based on computer games and Inactive Distraction based on playing music on anxiety and physiological indicators of removing the cast in children aged 8 to 12 years
Public title
Comparison of the effect of two methods of active Distraction based on computer games and Inactive Distraction based on playing music on anxiety and physiological indicators of removing the cast in children aged 8 to 12 years
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age over 8 years and under 12 years Have a upper or lower limb plastered Willingness to participant to study by parents and the child and signing the consent form at the beginning of the study Able to speak and understand Persian language Full consciousness and lack of drowsiness Child’s ability to answer the researcher's questions and cooperate during the test
Exclusion criteria:
Hearing and vision problems (Completely not hearing and not seeing despite the use of assistive devices) Mental illness (According to the statement of parents) Compartment syndrome Speech disorders and mental retardation, hyperactivity (According to the statement of parents) Pervasive anxiety disorders (According to the statement of parents) Take sedative or analgesic drugs for one hour before cast removal
Age
From 8 years old to 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 105
Randomization (investigator's opinion)
Randomized
Randomization description
The research participants are selected using a convenience sampling method from children requiring cast removal at Valiasr Hospital in Arak. They are then randomly assigned in equal numbers to three groups; Intervention 1 (passive distraction with music), Intervention 2 (active distraction with video games), and the control group, using block randomization with software. These groups undergo a clinical trial.
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
Ethics committee of Arak University of Medical Sciences
Street address
Arak University of Medical Sciences, Sardasht, Basij Square
City
Arak
Province
Markazi
Postal code
3848176941
Approval date
2020-07-26, 1399/05/05
Ethics committee reference number
IR.ARAKMU.REC.1399.163

Health conditions studied

1

Description of health condition studied
Orthopedics, limb fractures and joint dislocations
ICD-10 code
M96.6
ICD-10 code description
Fracture of bone following insertion of orthopedic implant, joint prosthesis, or bone plate

2

Description of health condition studied
Anxiety
ICD-10 code
F41.9
ICD-10 code description
Anxiety disorder, unspecified

Primary outcomes

1

Description
Anxiety
Timepoint
Before intervention and after intervention
Method of measurement
Children’s Emotional Manifestation Scale (CEMS), Visual Analogue Scale

2

Description
Heart beat
Timepoint
Immediately before the intervention, after the intervention
Method of measurement
Number of beats per minute - pulse oximeter

3

Description
Respiratory rate
Timepoint
Immediately before the intervention, after the intervention
Method of measurement
Count per minute - count breathing by observation

4

Description
Anxiety
Timepoint
Before intervention and after intervention
Method of measurement
Facial Anxiety Scale

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group 1: Inactive Distraction based on playing music; Before start removing the cast, researcher introduces the environment and equipment of cast room to the child, for to prevent the role of stress of unfamiliarity on the measurements. Then, for children in intervention group 1 (music therapy), from 5 minutes before the cast removal and during the procedure, as well as 2 minutes after the removing the cast, music appropriate to the age, sex and interest of the child is selected and played. All of the music that is used, has a beat of 80-60 beats per second and a volume of 40 to 50 decibels, and all of them have a smooth and uniform rotation melodic rhythm, and none of them are stimulating, sad or exciting. Playing the music is according to each child's situation via wireless headphones. Parents are asked not to talk to their children during the intervention. Other factors that may be used to reduce the child's stress (due to disruption of the assessment process) will also be avoided during the intervention.
Category
Treatment - Other

2

Description
Intervention group 2: Active Distraction based on computer games; Before start removing the cast, researcher introduces the environment and equipment of cast room to the child, for to prevent the role of stress of unfamiliarity on the measurements. Then, children will play games via tablet according to their age, gender and interest from 5 minutes before and 2 minutes after cast removal.
Category
Treatment - Other

3

Description
Control group: Children in this group did not receive any intervention and cast removal will be will be performed routinely without intervention.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Valiasr Hospital of Arak
Full name of responsible person
Ali Safdari
Street address
Valiasr Hospital, Valiasr squre, Shahid Shirodi street
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3417 3505
Email
asafdari.nu@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Alireza Kamali
Street address
Arak University of Medical Sciences, Sardasht, Basij Square
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3417 3505
Email
alikamaliir@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Arak University of Medical Sciences
Full name of responsible person
Ali Safdari
Position
Nursing student of Arak University of Medical Sciences
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Arak University of Medical Sciences, Sardasht, Basij Square
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3417 3505
Email
asafdari.nu@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Razieh Mokhtari
Position
Member of Arak Nursing Faculty
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Arak University of Medical Sciences, Sardasht, Basij Square
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3417 3505
Email
razieh.mokhtari91@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Ali Safdari
Position
Nursing student of Arak University of Medical Sciences
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Arak University of Medical Sciences, Sardasht, Basij Square
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3417 3505
Email
asafdari.nu@gmail.com

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
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