Protocol summary
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Study aim
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Determining of spiritual care training based on "Ghalbe Salim" model on self-efficacy in care and caregivers burden in mothers with leukemia children reffering to Imam Reza (AS) clinic of Shiraz University of Medical Sciences
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Design
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Interventional study before and after with the control group, with the parallel group, stage 2-3 on 64 mothers. To determine the permutation block sample (four), then demographic information, care pressure questionnaire and self-efficacy questionnaire are provided to both groups and the latest data are analyzed with SPSS software.
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Settings and conduct
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64 mothers with leukemia children (school age) reffering to Imam Reza (AS) clinic who are divided into two groups of 32 intervention and control using random method and permutation block method, then demographic information form, self-efficacy in care and caregivers burden to people in both groups as a pre-test. After that, the intervention group was given spiritual care training based on "Ghalbe Salim" in 4 sessions of 30 minutes, and then the self-efficacy in care and caregivers burden is done as a post-test and finally the data will be analyzed with SPSS software
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Participants/Inclusion and exclusion criteria
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Doing the mother's job as a caregiver
Child age between 6 to 12 years
Being a Muslim
Have a minimum of basic education
The mother is not physically or mentally ill
Lack of experience of a stressful event in the last 6 months
Must be able to speak Persian
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Intervention groups
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In the intervention group, mothers receive spiritual care training based on "Ghalbe Salim" in 4 sessions of 30 minutes, but in the control group, no intervention will be performed.
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Main outcome variables
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self-efficacy in care and caregivers burden in mothers
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:
IRCT20210410050924N1
Registration date:
2021-05-04, 1400/02/14
Registration timing:
registered_while_recruiting
Last update:
2021-05-11, 1400/02/21
Update count:
1
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Registration date
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2021-05-04, 1400/02/14
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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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2021-04-30, 1400/02/10
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Expected recruitment end date
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2021-06-20, 1400/03/30
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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 effect of spiritual care training based on "Ghalbe Salim" model on self-efficacy in care and caregivers burden in mothers with leukemia children reffering to Imam Reza (AS) clinic of Shiraz University of Medical Sciences- 2020
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Public title
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The effect of self-efficacy-based spiritual care training on the care and care pressure of mothers with leukemia children
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Purpose
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Supportive
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Inclusion/Exclusion criteria
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Inclusion criteria:
Perform motherly duties as a caregiver
The child is between 6 and 12 years old
Being a Muslim
The mother does not have a mental illness
The mother must be able to speak Persian
Mother Have at least primary education
Lack of experience of a stressful event in the last 6 months
Exclusion criteria:
Death of a child or mother during the intervention period
Immigrating to another country
The mother's unwillingness to continue cooperating in the study
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Age
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From 6 years old to 12 years old
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Gender
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Female
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Phase
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2-3
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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:
64
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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In this study, the researcher collects samples in a quadratic block method. In this way, each person who enters the study based on the permutation table identifies two groups of intervention and control as follows: control group A and intervention group B, and each block of 4 different shapes of placing A, B and There are generally 6 different modes that are numbered from 1 to 6. By rolling the dice, it is determined which order to choose. The researcher takes samples according to the specified order. He then rolls the dice again and executes another command. In the same way, continue sampling to reach the desired number.
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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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2021-03-03, 1399/12/13
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Ethics committee reference number
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IR.SUMS.REC.1399.1311
Health conditions studied
1
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Description of health condition studied
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Leukemia
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ICD-10 code
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C91
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ICD-10 code description
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Lymphoid leukemia
Primary outcomes
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Description
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self-efficacy in care
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Timepoint
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Before intervention, after intervention
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Method of measurement
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Zhang Care Self-Efficacy Questionnaire
Secondary outcomes
1
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Description
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care and caregivers burden
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Timepoint
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Before intervention and after intervention
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Method of measurement
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Novak and Gost Care Pressure Questionnaire
Intervention groups
1
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Description
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The intervention group, individually in 4 sessions for 30 to 45 minutes in each session and once a week, spiritual care is provided by the researcher using a booklet related to this care, including: Communication with God , With others, with yourself, with the environment, as approved by the tutor. In each session, one of the four aspects of human beings will be discussed and the educational booklet that the researcher has made based on the model of spiritual care based on the "Ghalbe Salim" model will be given to mothers in the same session.The researcher will also contact the mothers during the week and remind them of the implementation of spiritual care. One week after the end of the fourth intervention session, self-efficacy questionnaires in care and care pressure will be given to mothers as a post-test for the effect of the fourth session.
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Category
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Other
2
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Description
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No special intervention will be done for the control group, but at the end of the study, in order to comply with the ethical standards, spiritual care educational pamphlets based on the " Ghalbe Salim" model will be provided to the control group.
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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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Not applicable
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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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Not applicable
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Analytic Code
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Not applicable
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Data Dictionary
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Not applicable