Protocol summary
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Study aim
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Determining the effect of spiritual self-care training on sleep quality and severity of insomnia in diabetic adolescents
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Design
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Experimental study with test and control group, By available sampling method, Then randomization, on 66 diabetic adolescents aged 12 to 20 years, Sealed envelopes were used for randomization.
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Settings and conduct
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Experimental study on diabetic adolescents aged 12 to 20 years referred to Health and treatment centers of Qaemshahr city. First, by available sampling method, the Insomnia Intensity Questionnaire and the Peter Borg Sleep Quality Questionnaire were completed by qualified adolescents. Then divided into two groups of test and control by sealed envelopes. The test group will be trained in spiritual self-care.
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Participants/Inclusion and exclusion criteria
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Included criteria: Diabetes,
Age range between 12 to 20 years,
Family satisfaction with the continuous participation of subjects in training sessions,
No history of neurological and psychological diseases,
No drug abuse,
insomnia;
Criteria for non inclusion:
Suffering from various underlying diseases,
Mental disability
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Intervention groups
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Test group and control group. The test group is trained in spiritual self-care. The control group received routine care.
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Main outcome variables
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Program independent variable: spiritual self-care training and dependent variable: sleep quality and insomnia severity of diabetic adolescents and disturbing variable: age, gender, weight and average blood sugar
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20220327054359N1
Registration date:
2022-09-04, 1401/06/13
Registration timing:
retrospective
Last update:
2024-02-12, 1402/11/23
Update count:
1
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Registration date
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2022-09-04, 1401/06/13
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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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2022-05-20, 1401/02/30
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Expected recruitment end date
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2022-06-20, 1401/03/30
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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 effectiveness of spiritual self-care training on sleep quality and insomnia severity in adolescents with diabetes and its comparison with the control group
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Public title
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The effect of spiritual self-care training on the severity of insomnia and sleep quality of diabetic adolescents
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Purpose
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Education/Guidance
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Inclusion/Exclusion criteria
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Inclusion criteria:
Having diabetes
Age range between 20 to12 years
Family satisfaction with the continuous participation of the subjects in the training sessions
No history of neurological and psychological diseases
No drug abuse
insomnia
Exclusion criteria:
The presence of various underlying diseases
Mental disability
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Age
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From 12 years old to 20 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:
66
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Firstly, the samples will be selected by available sampling method as follows: After obtaining consent and stating the targets and providing the necessary information, the questionnaire severity insomnia and the Petersburg Quality of Sleep Questionnaire will be completed by diabetic patients with the help of a researcher.Then by using a secret envelope, will be selected for randomization into two groups of test and control. For randomization, the secret letters which previously prepared that containing numbers 1 (control group) and numbers 2 (test group) are given to individuals.
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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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Other
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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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2022-03-13, 1400/12/22
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Ethics committee reference number
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IR.IAU.D.REC.1401.004
Health conditions studied
1
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Description of health condition studied
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Insomnia and decreased sleep quality in diabetic adolescents
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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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Earning score of 15 to 21 has meaning of moderate and 22 to 28 has meaning of severe insomnia in Insomnia Intensity questionnaire and earning score of 6 and more than 6 has meaning of unpleasant of sleep quality in Petersburg Sleep Quality Inventory.
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Timepoint
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30 DAYS
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Method of measurement
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Petersburg Sleep Quality Questionnaire and Insomnia Intensity Questionnaire
Intervention groups
1
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Description
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Test group is diabetic adolescents 12 to 20 years that educated in White's spiritual self care training. White's spiritual self-care training is held in 6 sessions of 30 to 45 minutes. This training is in 5 areas: Self control, Performing religious duties, Personal activities, Getting close to God, Asking God for help
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Category
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Behavior
2
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Description
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Control group: This group are not trained and receives routine care. After completing the research educational materials will be provided to them.
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Category
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Behavior
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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Islamic Azad University, Aliabad Katoul Branch
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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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No - There is not a plan to make this available
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Justification/reason for indecision/not sharing IPD
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There is no more information
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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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No - There is not a plan to make this available
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Informed Consent Form
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No - There is not a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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No - There is not a plan to make this available
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Data Dictionary
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No - There is not a plan to make this available
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Title and more details about the data/document
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Some personal data, such as information about the main outcome, can be shared.
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When the data will become available and for how long
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The access period starts from 2022
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To whom data/document is available
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Researchers
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Under which criteria data/document could be used
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Researchers if they want to use the available data with the permission of the original researchers.
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From where data/document is obtainable
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Islamic Azad University, Aliabad Katoul Branch, Nafiseh Hekmatipour, 01734237933
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What processes are involved for a request to access data/document
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Approval of the Vice Chancellor for Research, Islamic Azad University, Aliabad Katoul Branch
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Comments
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2 articles will be extracted from this proposal.