Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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IRCT |
Last refreshed on:
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22 February 2018 |
Main ID: |
IRCT2017082326347N6 |
Date of registration:
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2017-11-07 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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The effect of life skills-based interventions on stress, anxiety and depression in patients with type 1 diabetes
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Scientific title:
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The effect of life skills-based interventions on stress, anxiety and depression in patients with type 1 diabetes |
Date of first enrolment:
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2017-07-23 |
Target sample size:
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80 |
Recruitment status: |
Complete |
URL:
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http://en.irct.ir/trial/21856 |
Study type:
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interventional |
Study design:
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Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Other design features: The randomized assignment of the groups into two groups is as follows: on the sheets of numbers 1 to 80 will be written and, after being placed in a container, will be asked from patients, each of which will be one In the end, individuals with paired numbers in the intervention group and individuals with numbers in the control group will be placed at random.
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Phase:
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N/A
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Countries of recruitment
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Iran (Islamic Republic of)
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Contacts
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Name:
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Soheila Ahangarzadeh Rezaei
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Address:
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Faculty of Nursing and Midwifery, Pardis Nazlou, 11 km Road sero
Urmia
Iran (Islamic Republic of) |
Telephone:
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+98 443275496361 |
Email:
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nursing-college@umsu.ac.ir |
Affiliation:
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Urmia Nursing and Midwifery Faculty |
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Name:
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Sayedeh Farideh Hashemi
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Address:
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Faculty of Nursing and Midwifery, Pardis Nazlou, 11 km Road sero
5551338335
Urmia
Iran (Islamic Republic of) |
Telephone:
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+98 44 3275 4961 |
Email:
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f.hashemi9062@gmail.com |
Affiliation:
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Urmia Nursing and Midwifery Faculty |
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Key inclusion & exclusion criteria
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Inclusion criteria: Entry criteria: Type 1 diabetes; Age range of 40-40; Case records in the Diabetes Association; Physical and mental health; Ability to answer questions; Have a reading and writing literacy; Drug addiction; Do not attend. 6 months ago at the store of life skills according to the patient's opinion
Exclusion criteria:
Age minimum:
84 years
Age maximum:
59 years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Diabets. With coma,With ketoacidosis ,With renal complications,With ophthalmic complications ,With neurological complications ,With peripheral circulatory complications ,With other specified complications ,With multiple complications ,With unspecified complication
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E10.0,E10.
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With coma,With ketoacidosis ,With renal complications,With ophthalmic complications ,With neurological complications ,With peripheral circulatory complications ,With other specified complications ,With multiple complications ,With unspecified complication
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Intervention(s)
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Control group: This group does not receive any intervention. The mean of stress, anxiety and depression was compared by using the DASS-21 questionnaire in the pre-intervention, post-intervention, and 2-month intervals after intervention.
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Intervention 1: The intervention group was first measured by the DASS-21 questionnaire. The mean of depression, anxiety and stress was measured and then the intervention group in 9 sessions of life skills training included self-awareness, stress management, problem-solving and effective communication skills, which was conducted by a psychologist Runs, participate. Then, the mean of depression, anxiety and stress after the completion of the intervention and two months after the intervention measure and the results are compared. Intervention 2: Control group: This group does not receive any intervention. The mean of stress, anxiety and depression was compared by using the DASS-21 questionnaire in the pre-intervention, post-intervention, and 2-month intervals after intervention.
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The intervention group was first measured by the DASS-21 questionnaire. The mean of depression, anxiety and stress was measured and then the intervention group in 9 sessions of life skills training included self-awareness, stress management, problem-solving and effective communication skills, which was conducted by a psychologist Runs, participate. Then, the mean of depression, anxiety and stress after the completion of the intervention and two months after the intervention measure and the results are compared
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Primary Outcome(s)
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Depression. Timepoint: Before intervention - after intervention - two months after intervention. Method of measurement: Dass-21 questionnaire.
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Anxiety. Timepoint: Before intervention - after intervention - two months after intervention. Method of measurement: Dass-21 questionnaire.
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Stress. Timepoint: Before intervention - after intervention - two months after intervention. Method of measurement: Dass-21 questionnaire.
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Source(s) of Monetary Support
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Vice Chancellor For Research Of Urmia University Of Medical Scinces
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Ethics review
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Status: Approved
Approval date:
Contact:
Ethics Committee of Urmia University of Medical Sciences
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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