The effect of virtual painting therapy on anxiety, depression and self-efficacy amongst 8-12 years old children with type 1 diabetes referring to Imam Reza Diabetes Clinic, Shiraz, 2019
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
Determining the effect of painting therapy on anxiety, depression and self-efficacy amongst 8-12 years old children with type 1 diabetes referring to Imam Reza Diabetes Clinic, Shiraz, 2019
Determining the effect of virtual painting therapy on anxiety, depression and self-efficacy amongst 8-12 years old children with type 1 diabetes referring to Imam Reza Diabetes Clinic, Shiraz, 2019
Determining the effect of virtual painting therapy on anxiety, depression and self-efficacy amongst 8-12 years old children with type 1 diabetes referring to Imam Reza Diabetes Clinic, Shiraz, 2019
تعیین تاثیر نقاشی درمانی بر اضطراب، افسردگی و خودکارآمدی کودکان 12-8 ساله مبتلا به دیابت نوع 1 مراجعه کننده به کلینیک دیابت درمانگاه امام رضا (ع) شیراز سال 1398
تعیین تاثیر نقاشی درمانی مجازی بر اضطراب، افسردگی و خودکارآمدی کودکان 12-8 ساله مبتلا به دیابت نوع 1 مراجعه کننده به کلینیک دیابت درمانگاه امام رضا (ع) شیراز سال 1398
تعیین تاثیر نقاشی درمانی مجازی بر اضطراب، افسردگی و خودکارآمدی کودکان 12-8 ساله مبتلا به دیابت نوع 1 مراجعه کننده به کلینیک دیابت درمانگاه امام رضا (ع) شیراز سال 1398
The place of the study will be Imam Reza Diabetes Clinic of Shiraz. Samples will be divided into two groups of intervention and control by using permutation block method and both groups will complete four demographic, anxiety, depression and self-efficacy questionnaires. Then the intervention group will attend 6 two-hour painting sessions for 6 weeks and the control group will receive usual care of diabetes clinic. After these 6 weeks, the anxiety, depression and self-efficacy questionnaire will be completed by both groups.
The place of the study will be Imam Reza Diabetes Clinic of Shiraz. Samples will be divided into two groups of intervention and control by using permutation block method and both groups will complete four demographic, anxiety, depression and self-efficacy questionnaires. Then, the intervention group will participate in 6 sessions of virtual painting therapy class for 6 weeks and the control group will receive usual care of diabetes clinic. After these 6 weeks, the anxiety, depression and self-efficacy questionnaire will be completed by both groups.
The place of the study will be Imam Reza Diabetes Clinic of Shiraz. Samples will be divided into two groups of intervention and control by using permutation block method and both groups will complete four demographic, anxiety, depression and self-efficacy questionnaires. Then, the intervention group will attendparticipate in 6 two-hoursessions of virtual painting sessionstherapy class for 6 weeks and the control group will receive usual care of diabetes clinic. After these 6 weeks, the anxiety, depression and self-efficacy questionnaire will be completed by both groups.
محل انجام مطالعه، کلینیک دیابت درمانگاه امام رضا (ع) شیراز خواهد بود. نمونهها با روش بلوک جایگشتی به دو گروه مداخله و کنترل تقسیم و هردو گروه چهار پرسشنامه اطلاعات دموگرافیک، اضطراب، افسردگی و خودکارآمدی تکمیل خواهند کرد. سپس گروه مداخله به مدت 6 هفته در 6 جلسه دو ساعته نقاشی شرکت مینمایند و گروه کنترل مراقبت معمول کلینیک دیابت را دریافت خواهند نمود. پس از پایان این 6 هفته پرسشنامه اضطراب، افسردگی و خودکارآمدی توسط دو گروه تکمیل خواهد شد.
محل انجام مطالعه، کلینیک دیابت درمانگاه امام رضا (ع) شیراز خواهد بود. نمونهها با روش بلوک جایگشتی به دو گروه مداخله و کنترل تقسیم و هردو گروه چهار پرسشنامه اطلاعات دموگرافیک، اضطراب، افسردگی و خودکارآمدی تکمیل خواهند کرد. سپس گروه مداخله به مدت 6 هفته در 6 جلسه دو ساعته کلاس نقاشی درمانی مجازی شرکت مینمایند و گروه کنترل مراقبت معمول کلینیک دیابت را دریافت خواهند نمود. پس از پایان این 6 هفته پرسشنامه اضطراب، افسردگی و خودکارآمدی توسط دو گروه تکمیل خواهد شد.
محل انجام مطالعه، کلینیک دیابت درمانگاه امام رضا (ع) شیراز خواهد بود. نمونهها با روش بلوک جایگشتی به دو گروه مداخله و کنترل تقسیم و هردو گروه چهار پرسشنامه اطلاعات دموگرافیک، اضطراب، افسردگی و خودکارآمدی تکمیل خواهند کرد. سپس گروه مداخله به مدت 6 هفته در 6 جلسه دو ساعته کلاس نقاشی درمانی مجازی شرکت مینمایند و گروه کنترل مراقبت معمول کلینیک دیابت را دریافت خواهند نمود. پس از پایان این 6 هفته پرسشنامه اضطراب، افسردگی و خودکارآمدی توسط دو گروه تکمیل خواهد شد.
Intervention group: 6 two-hour sessions of painting class in 6 weeks for intervention group will be held . Control group: in control group no intervention is performed.
Intervention group:6 sessions of two-hour virtual painting therapy class are held for 6 weeks for the intervention group. Control group: in control group no intervention is performed.
Intervention group:6 sessions of two-hour sessions ofvirtual painting therapy class inare held for 6 weeks for the intervention group will be held . Control group: in control group no intervention is performed.
گروه مداخله: 6 جلسه 2 ساعته کلاس نقاشی به مدت 6 هفته برای گروه مداخله برگزار میشود. گروه کنترل: در گروه کنترل هیچ مداخلهای انجام نمیشود.
گروه مداخله: 6 جلسه 2ساعته کلاس نقاشیدرمانی مجازی به مدت 6 هفته برای گروه مداخله برگزار میشود. گروه کنترل: در گروه کنترل هیچ مداخلهای انجام نمیشود.
گروه مداخله: 6 جلسه 2 ساعته2ساعته کلاس نقاشیدرمانی مجازی به مدت 6 هفته برای گروه مداخله برگزار میشود. گروه کنترل: در گروه کنترل هیچ مداخلهای انجام نمیشود.
General information
empty
Due to the limitations caused by Covid-19 disease and the impossibility of holding group painting therapy classes for amongst 8-12 years old children with type 1 diabetes referring to Imam Reza Diabetes Clinic, painting therapy sessions are held virtually.
Due to the limitations caused by Covid-19 disease and the impossibility of holding group painting therapy classes for amongst 8-12 years old children with type 1 diabetes referring to Imam Reza Diabetes Clinic, painting therapy sessions are held virtually.
empty
با توجه به محدودیت های ناشی از بیماری کووید-19 و عدم امکان برگزاری کلاسهای گروهی نقاشیدرمانی جهت کودکان 12-8 ساله مبتلا به دیابت نوع یک مراجعه کننده به کلینیک دیابت درمانگاه امام رضا (ع)، جلسات نقاشیدرمانی به صورت مجازی برگزار میشود.
با توجه به محدودیت های ناشی از بیماری کووید-19 و عدم امکان برگزاری کلاسهای گروهی نقاشیدرمانی جهت کودکان 12-8 ساله مبتلا به دیابت نوع یک مراجعه کننده به کلینیک دیابت درمانگاه امام رضا (ع)، جلسات نقاشیدرمانی به صورت مجازی برگزار میشود.
The effect of painting therapy on anxirty, depression and self-efficacy amongst 8-12 years old children with type 1 diabetes
The effect of virtual painting therapy on anxiety, depression and self-efficacy amongst 8-12 years old children with type 1 diabetes
The effect of virtual painting therapy on anxirtyanxiety, depression and self-efficacy amongst 8-12 years old children with type 1 diabetes
تاثیر نقاشی درمانی بر اضطراب، افسردگی و خودکارآمدی کودکان 12-8 ساله مبتلا به دیابت نوع 1
تاثیر نقاشی درمانی مجازی بر اضطراب، افسردگی و خودکارآمدی کودکان 12-8 ساله مبتلا به دیابت نوع 1
تاثیر نقاشی درمانی مجازی بر اضطراب، افسردگی و خودکارآمدی کودکان 12-8 ساله مبتلا به دیابت نوع 1
The effect of painting therapy on anxirty, depression and self-efficacy amongst 8-12 years old children with type 1 diabetes referring to Imam Reza Diabetes Clinic, Shiraz, 2019
The effect of virtual painting therapy on anxiety, depression and self-efficacy amongst 8-12 years old children with type 1 diabetes referring to Imam Reza Diabetes Clinic, Shiraz, 2019
The effect of virtual painting therapy on anxirtyanxiety, depression and self-efficacy amongst 8-12 years old children with type 1 diabetes referring to Imam Reza Diabetes Clinic, Shiraz, 2019
تاثیر نقاشی درمانی بر اضطراب، افسردگی و خودکارآمدی کودکان 12-8 ساله مبتلا به دیابت نوع 1 مراجعه کننده به کلینیک دیابت درمانگاه امام رضا (ع) شیراز سال 1398
تاثیر نقاشی درمانی مجازی بر اضطراب، افسردگی و خودکارآمدی کودکان 12-8 ساله مبتلا به دیابت نوع 1 مراجعه کننده به کلینیک دیابت درمانگاه امام رضا (ع) شیراز سال 1398
تاثیر نقاشی درمانی مجازی بر اضطراب، افسردگی و خودکارآمدی کودکان 12-8 ساله مبتلا به دیابت نوع 1 مراجعه کننده به کلینیک دیابت درمانگاه امام رضا (ع) شیراز سال 1398
Intervention groups
#1
Intervention group: 6 two-hour sessions of painting class under the supervision of psychologist in 6 weeks for intervention group will be held. These sessions include painting and depicting dreams and fears. Painting supplies including colored pencils, watercolors, Crayons and marker will be provided to the children, and the child will be encouraged to depict their feelings of sadness, anger, fear, and happiness by using colors. After 6 weeks of painting class, anxiety, depression and self-efficacy questionnaire will again be completed by children in intervention and control group.
Intervention group: 6 two-hour sessions of virtual painting therapy class for 6 weeks through Whats App software under the supervision of a psychologist for the intervention group will be held.These sessions include painting and depicting dreams and fears. Painting supplies including colored pencils, watercolors, Crayons and marker will be provided to the children, and the child will be encouraged to depict their feelings of sadness, anger, fear, and happiness by using colors. After 6 weeks of painting therapy class, anxiety, depression and self-efficacy questionnaire will again be completed by children in intervention and control group.
Intervention group: 6 two-hour sessions of virtual painting therapy class for 6 weeks through Whats App software under the supervision of a psychologist in 6 weeks for the intervention group will be held. Theseheld.These sessions include painting and depicting dreams and fears. Painting supplies including colored pencils, watercolors, Crayons and marker will be provided to the children, and the child will be encouraged to depict their feelings of sadness, anger, fear, and happiness by using colors. After 6 weeks of painting therapy class, anxiety, depression and self-efficacy questionnaire will again be completed by children in intervention and control group.
گروه مداخله: 6 جلسه دو ساعته کلاس نقاشی به مدت 6 هفته زیر نظر روانشناس برای گروه مداخله برگزار میشود. این جلسات شامل نقاشی و به تصویر کشیدن رویاها و ترسها است. وسایل نقاشی شامل مداد رنگی، آبرنگ، مدادشمعی و ماژیک در اختیار کودکان قرار خواهد گرفت و کودک تشویق خواهد شد با استفاده از رنگها، احساس ناراحتی، عصبانیت، ترس و آرزوها و خوشحالی خود را به تصویر بکشد. پس از پایان 6 هفته کلاس نقاشی مجدداً پرسشنامه اضطراب، افسردگی و خودکارآمدی توسط کودکان گروه مداخله و کنترل تکمیل خواهد شد.
گروه مداخله: گروه مداخله: 6 جلسه دو ساعته کلاس نقاشیدرمانی مجازی به مدت 6 هفته از طریق نرم افزار واتساپ زیر نظر روانشناس برای گروه مداخله برگزار میشود. این جلسات شامل نقاشی و به تصویر کشیدن رویاها و ترسها است. وسایل نقاشی شامل مداد رنگی، آبرنگ، مدادشمعی و ماژیک در اختیار کودکان قرار خواهد گرفت و کودک تشویق خواهد شد با استفاده از رنگها، احساس ناراحتی، عصبانیت، ترس و آرزوها و خوشحالی خود را به تصویر بکشد. پس از پایان 6 هفته کلاس نقاشیدرمانی مجدداً پرسشنامه اضطراب، افسردگی و خودکارآمدی توسط کودکان گروه مداخله و کنترل تکمیل خواهد شد.
گروه مداخله: گروه مداخله: 6 جلسه دو ساعته کلاس نقاشیدرمانی مجازی به مدت 6 هفته از طریق نرم افزار واتساپ زیر نظر روانشناس برای گروه مداخله برگزار میشود. این جلسات شامل نقاشی و به تصویر کشیدن رویاها و ترسها است. وسایل نقاشی شامل مداد رنگی، آبرنگ، مدادشمعی و ماژیک در اختیار کودکان قرار خواهد گرفت و کودک تشویق خواهد شد با استفاده از رنگها، احساس ناراحتی، عصبانیت، ترس و آرزوها و خوشحالی خود را به تصویر بکشد. پس از پایان 6 هفته کلاس نقاشیدرمانی مجدداً پرسشنامه اضطراب، افسردگی و خودکارآمدی توسط کودکان گروه مداخله و کنترل تکمیل خواهد شد.
Protocol summary
Study aim
Determining the effect of virtual painting therapy on anxiety, depression and self-efficacy amongst 8-12 years old children with type 1 diabetes referring to Imam Reza Diabetes Clinic, Shiraz, 2019
Design
Clinical trial with control group, With parallel groups, Randomised
Settings and conduct
The place of the study will be Imam Reza Diabetes Clinic of Shiraz. Samples will be divided into two groups of intervention and control by using permutation block method and both groups will complete four demographic, anxiety, depression and self-efficacy questionnaires. Then, the intervention group will participate in 6 sessions of virtual painting therapy class for 6 weeks and the control group will receive usual care of diabetes clinic. After these 6 weeks, the anxiety, depression and self-efficacy questionnaire will be completed by both groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria:1- The age range of children between 8 to12 years 2- At least 3 months have passed since the patient's diabetes diagnosis 3-The child has no chronic disease exept type 1 diabetes 4-The history of mental and physical problems that lead to mental retardation in children was not mentioned in the file 5- Have a file in the diabetes clinic 6-Anxiety score of 45 and above 45 7- The child and parents tend to continue to collaborate in research ؛ Exclusion criteria:1- For whatever reason the child absent from painting sessions
Intervention groups
Intervention group:6 sessions of two-hour virtual painting therapy class are held for 6 weeks for the intervention group. Control group: in control group no intervention is performed.
Main outcome variables
Anxiety ؛ Depression ؛ Self-efficacy
General information
Reason for update
Due to the limitations caused by Covid-19 disease and the impossibility of holding group painting therapy classes for amongst 8-12 years old children with type 1 diabetes referring to Imam Reza Diabetes Clinic, painting therapy sessions are held virtually.
Acronym
IRCT registration information
IRCT registration number:IRCT20200118046181N1
Registration date:2020-03-17, 1398/12/27
Registration timing:prospective
Last update:2020-09-12, 1399/06/22
Update count:1
Registration date
2020-03-17, 1398/12/27
Registrant information
Name
Mina Zamanifard
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 5433 4275
Email address
m_zamani@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-03-30, 1399/01/11
Expected recruitment end date
2020-04-30, 1399/02/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of virtual painting therapy on anxiety, depression and self-efficacy amongst 8-12 years old children with type 1 diabetes referring to Imam Reza Diabetes Clinic, Shiraz, 2019
Public title
The effect of virtual painting therapy on anxiety, depression and self-efficacy amongst 8-12 years old children with type 1 diabetes
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
The age range of children between 8 to12 years
At least 3 months have passed since the patient's diabetes diagnosis
The child has no chronic disease exept type 1 diabetes
The history of mental and physical problems that lead to mental retardation in children was not mentioned in the file
Have a file in the diabetes clinic
Anxiety score of 45 and above 45
The child and parents tend to continue to collaborate in research
Exclusion criteria:
For whatever reason the child absent from painting sessions
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:
40
Randomization (investigator's opinion)
Randomized
Randomization description
To determine intervention and control group, four- size blocks with 6 permutations are used. The permutations are numbered and selected randomly. Arrangement of selected permutation enters to table unit all samples in 2 groups are selected.
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 Shiraz University of Medical Sciences
Street address
Central Building of Shiraz University of Medical Sciences, Zand Street, Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
71348-14336
Approval date
2020-01-15, 1398/10/25
Ethics committee reference number
IR.SUMS.REC.1398.1194
Health conditions studied
1
Description of health condition studied
Diabetes
ICD-10 code
E10
ICD-10 code description
Type 1 diabetes mellitus
Primary outcomes
1
Description
Anxiety
Timepoint
Before and after intervention
Method of measurement
Spence Children Anxiety Scale (SCAS)
2
Description
Depression
Timepoint
Before and after intervention
Method of measurement
Children’s Depression Inventory (CDI)
3
Description
Self-efficacy
Timepoint
Before and after intervention
Method of measurement
Diabetes management self-efficacy scale (SMSES)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 6 two-hour sessions of virtual painting therapy class for 6 weeks through Whats App software under the supervision of a psychologist for the intervention group will be held.These sessions include painting and depicting dreams and fears. Painting supplies including colored pencils, watercolors, Crayons and marker will be provided to the children, and the child will be encouraged to depict their feelings of sadness, anger, fear, and happiness by using colors. After 6 weeks of painting therapy class, anxiety, depression and self-efficacy questionnaire will again be completed by children in intervention and control group.
Category
Treatment - Other
2
Description
Control group: in the control group, no intervention will be performed.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Diabetes Clinic, Shiraz
Full name of responsible person
Razie Attar
Street address
Imam Reza Clinic Next to Namazi Hospital, Namazi Square, Shiraz
City
Shiraz
Province
Fars
Postal code
714737-71348
Phone
+98 71 3212 7605
Fax
+98 71 3647 4673
Email
bonyaddiabet.az13@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Younes Ghasemi
Street address
Vice-Chancellor for Research & Technology - Seventh Floor - Central Building of Shiraz University of Medical Sciences, Zand Street, Shiraz
City
Shiraz
Province
Fars
Postal code
71348-14336
Phone
+98 71 3235 7282
Fax
Email
vcrdep@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Mina Zamanifard
Position
Master of Pediatric Nursing Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Hazrate Fatemeh Nursing and Midwifery Faculty, Namazi Square, Shiraz
City
Shiraz
Province
Fars
Postal code
71936-13119
Phone
+98 71 3647 4254
Email
m_zamani@sums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Mitra Soltanian
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Fatemeh college of Nursing and Midwifery, Namazee square, Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
71936-13119
Phone
+98 71 3647 4254
Email
Soltanian@sums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mina Zamanifard
Position
Master of Pediatric Nursing Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Hazrate Fatemeh Nursing and Midwifery Faculty, Namazi Square, Shiraz
City
Shiraz
Province
Fars
Postal code
71936-13119
Phone
+98 71 3647 4254
Email
m_zamani@sums.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