Protocol summary
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Study aim
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Determining the effect of stress management training on coping strategies with stress and self-efficacy in hemodialysis patients
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Design
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Information on coping strategies with stress and self-efficacy will be collected immediately and 1 month after the intervention (for follow-up) from both groups. The intervention will be performed by a trained researcher during the dialysis after the stabilization of vital signs and physical condition in the dialysis ward in a calm environment in groups of 5 to 6 people. To control the effect of training on the control group, the sessions are performed on days when the patients in the control group are not present in the dialysis center.
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Settings and conduct
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hemodialysis ward of Imam Khomeini Hospital in Jiroft
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Participants/Inclusion and exclusion criteria
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patients undergoing hemodialysis in Imam Khomeini Hospital
Inclusion criteria
1. Physical and mental ability to complete the questionnaire
2. Ability to understand the Persian language
3. Absence of a stressful event at least 6 months before the study
4. Not participating in stress management workshops
5. Being between 17 and 65 years old
6. At least 3 months have passed since the beginning of their dialysis
7. No substance abuse or mental illness that requires medication
Exclusion criteria:
1. Not participating in training sessions (two sessions)
2. Occurrence of a stressful and severe event during the study
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Intervention groups
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Patients in the intervention group, in addition to receiving routine medical care, will be intervened in eight sessions of one and a half hours twice a week
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Main outcome variables
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coping strategies with stress and self-efficacy
General information
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Reason for update
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All 85 patients in the dialysis center were purposefully evaluated in terms of inclusion criteria, 65 eligible patients, Five samples were excluded from the study for various reasons, so the results of 60 samples were analyzed. ِDivided into intervention and control groups (30 in each group) based on random block allocation.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20160914029817N10
Registration date:
2021-10-07, 1400/07/15
Registration timing:
retrospective
Last update:
2021-10-22, 1400/07/30
Update count:
2
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Registration date
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2021-10-07, 1400/07/15
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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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2019-10-12, 1398/07/20
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Expected recruitment end date
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2020-01-12, 1398/10/22
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Actual recruitment start date
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2019-12-13, 1398/09/22
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Actual recruitment end date
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2020-01-12, 1398/10/22
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Trial completion date
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2020-01-12, 1398/10/22
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Scientific title
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The effect of stress management training on coping strategies with stress and self-efficacy in hemodialysis patients
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Public title
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The effect of stress management training on coping strategies with stress and self-efficacy in hemodialysis patients
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Purpose
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Education/Guidance
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Inclusion/Exclusion criteria
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Inclusion criteria:
1- Physical and mental ability to complete the questionnaire
2- Ability to understand the Persian language
3- Absence of a stressful event at least 6 months before the study
4- Not participating in stress management workshops
5- Being between 17 and 65 years old
6- At least 3 months have passed since they started dialysis
7. No substance abuse or mental illness that requires medication
Exclusion criteria:
1- Not participating in training sessions (two sessions)
2. Occurrence of a stressful and severe event during the study
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Age
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From 17 years old to 65 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:
85
Actual sample size reached:
60
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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To conduct the study, after obtaining the code of ethics from the ethics committee of Kerman University of Medical Sciences, the researcher will refer to the dialysis ward of Imam Khomeini Hospital in Jiroft, and obtain the necessary permission to conduct the study from the hospital management, dialysis ward. The eligible patients were selected and divided into intervention and control groups (30 in each group) based on random block allocation.
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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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2019-06-15, 1398/03/25
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Ethics committee reference number
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IR.KMU.REC.1398.325
Health conditions studied
1
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Description of health condition studied
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Strategies for coping with stress and self-efficacy in patients undergoing hemodialysis
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ICD-10 code
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ICD-10 code description
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Primary outcomes
1
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Description
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Strategies for coping with stress in patients undergoing hemodialysis
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Timepoint
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Before intervention , Immediately and 1 month after the intervention
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Method of measurement
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Using the Billings and Mouse Stress Management Questionnaire
2
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Description
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Self-efficacy in patients undergoing hemodialysis
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Timepoint
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Before intervention , Immediately and 1 month after the intervention
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Method of measurement
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Using the sheerer self-efficacy questionnaire
Intervention groups
1
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Description
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Intervention group: Eight sessions of one and a half hours twice a week for stress management training
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Category
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Behavior
2
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Description
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Control group: The usual care of the ward is done.
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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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No
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Title of funding source
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Free
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Proportion provided by this source
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10
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Public or private sector
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Private
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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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Other
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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Not applicable
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Data Dictionary
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Not applicable