The effectiveness of spiritual self-care training on sleep quality and insomnia severity in adolescents with diabetes and its comparison with the control group
Determining the effect of spiritual self-care training on sleep quality and severity of insomnia in diabetic adolescents
Design
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.
Settings and conduct
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.
Participants/Inclusion and exclusion criteria
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
Intervention groups
Test group and control group. The test group is trained in spiritual self-care. The control group received routine care.
Main outcome variables
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
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220327054359N1
Registration date:2022-09-04, 1401/06/13
Registration timing:retrospective
Last update:2022-09-04, 1401/06/13
Update count:1
Registration date
2022-09-04, 1401/06/13
Registrant information
Name
Elham Valipour Eskandarkolaii
Name of organization / entity
Islamic Azad University of Aliabad Katool
Country
Iran (Islamic Republic of)
Phone
+98 11 4227 6928
Email address
valipourelhame@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-05-20, 1401/02/30
Expected recruitment end date
2022-06-20, 1401/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of spiritual self-care training on sleep quality and insomnia severity in adolescents with diabetes and its comparison with the control group
Public title
The effect of spiritual self-care training on the severity of insomnia and sleep quality of diabetic adolescents
Purpose
Education/Guidance
Inclusion/Exclusion criteria
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
Age
From 12 years old to 20 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
66
Randomization (investigator's opinion)
Randomized
Randomization description
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.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Islamic Azad University, Dezful Branch
Street address
Tehran St., Orchid Alley, corner of Khorram 11- Aseman Complex
City
Qaemshahr
Province
Mazandaran
Postal code
4765785996
Approval date
2022-03-13, 1400/12/22
Ethics committee reference number
IR.IAU.D.REC.1401.004
Health conditions studied
1
Description of health condition studied
Insomnia and decreased sleep quality in diabetic adolescents
ICD-10 code
E10
ICD-10 code description
Type 1 diabetes mellitus
Primary outcomes
1
Description
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.
Timepoint
30 DAYS
Method of measurement
Petersburg Sleep Quality Questionnaire and Insomnia Intensity Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
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
Category
Behavior
2
Description
Control group: This group are not trained and receives routine care. After completing the research educational materials will be provided to them.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Diabetes Clinic of Bu Ali Sina Hospital, Sari
Full name of responsible person
Elham Valipour Eskandarkolaii
Street address
University blvd
City
Aliabad katul
Province
Golestan
Postal code
4941793451
Phone
+98 17 3422 2300
Email
valipourelhame@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University, Aliabad Katoul Branch
Full name of responsible person
dr. Nafise Hekmatipour
Street address
University Blvd
City
Aliabad Katul
Province
Golestan
Postal code
49417-93451
Phone
+98 17 3422 2300
Fax
+98 17 3422 5673
Email
info@aliabadiau.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University, Aliabad Katoul Branch
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
Islamic Azad University, Aliabad Katoul Branch
Full name of responsible person
Elham Valipour Eskandarkolaii
Position
Master of science student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
University blvd
City
Aliabad katul
Province
Golestan
Postal code
4941793451
Phone
+98 17 3422 2300
Email
valipourelhame@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University, Ali Abad katol Branch
Full name of responsible person
Nafise Hekmatipour
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Islamic Azad University, Ali Abad katol Branch
Street address
University Blvd
City
Ali Abad katol
Province
Golestan
Postal code
93451-49417
Phone
+98 911 279 9047
Fax
+98 17 3422 5673
Email
n_hekmati68@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University, Aliabad Katoul Branch
Full name of responsible person
Elham Valipour Eskandarkolaii
Position
Masters of science student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
University blvd
City
Aliabad Katoul
Province
Golestan
Postal code
4941793451
Phone
+98 17 3422 2300
Email
valipourelhame@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no more information
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Some personal data, such as information about the main outcome, can be shared.
When the data will become available and for how long
The access period starts from 2022
To whom data/document is available
Researchers
Under which criteria data/document could be used
Researchers if they want to use the available data with the permission of the original researchers.
From where data/document is obtainable
Islamic Azad University, Aliabad Katoul Branch, Nafiseh Hekmatipour, 01734237933
What processes are involved for a request to access data/document
Approval of the Vice Chancellor for Research, Islamic Azad University, Aliabad Katoul Branch