Protocol summary
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Study aim
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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
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Design
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Clinical trial with control group, With parallel groups, Randomised
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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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
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Intervention groups
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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.
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Main outcome variables
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Anxiety ؛ Depression ؛ Self-efficacy
General information
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Reason for update
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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.
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Acronym
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IRCT registration information
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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
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Registration date
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2020-03-17, 1398/12/27
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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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2020-03-30, 1399/01/11
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Expected recruitment end date
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2020-04-30, 1399/02/11
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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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
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Public title
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The effect of virtual painting therapy on anxiety, depression and self-efficacy amongst 8-12 years old children with type 1 diabetes
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Purpose
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Supportive
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Inclusion/Exclusion criteria
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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
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Age
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From 8 years old to 12 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:
40
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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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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2020-01-15, 1398/10/25
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Ethics committee reference number
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IR.SUMS.REC.1398.1194
Health conditions studied
1
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Description of health condition studied
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Diabetes
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ICD-10 code
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E10
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ICD-10 code description
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Type 1 diabetes mellitus
Primary outcomes
1
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Description
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Anxiety
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Timepoint
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Before and after intervention
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Method of measurement
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Spence Children Anxiety Scale (SCAS)
2
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Description
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Depression
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Timepoint
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Before and after intervention
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Method of measurement
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Children’s Depression Inventory (CDI)
3
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Description
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Self-efficacy
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Timepoint
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Before and after intervention
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Method of measurement
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Diabetes management self-efficacy scale (SMSES)
Intervention groups
1
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Description
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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.
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Category
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Treatment - Other
2
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Description
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Control group: in the control group, no intervention will be performed.
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Category
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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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Shiraz 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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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available