Protocol summary
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Study aim
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The effect of spiritual self-care model and the developed parallel process model on the burden of care, resilience and self-efficacy of spouses of post-war stress vetera (PTSD).
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Design
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This research is a semi-experimental study with two intervention groups and one control group, without blinding, randomized on 45 people. Randomization will be done using the website sealedenvelope.com.
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Settings and conduct
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The environment of this research is the counseling centers of Shahid Torbat Foundation in Heydarieh and Mashhad, and the community of this research is the spouses of veterans with post-traumatic stress disorder (PTSD). Blinding will not be done in this study.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: Spouses of people with post-traumatic stress disorder caused by the blast wave; living with their spouses at the moment; awareness of time and place. Non-inclusion criteria: People who do not want to participate in the study.
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Intervention groups
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Intervention groups 1: individual or group training sessions will be implemented based on the structures of the spiritual self-care model and intervention group 2: based on the developed parallel process model. Control group: receiving care and routine training of the centers.
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Main outcome variables
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self efficacy, burden of care, resilience
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:
IRCT20230608058420N1
Registration date:
2023-07-01, 1402/04/10
Registration timing:
registered_while_recruiting
Last update:
2024-02-11, 1402/11/22
Update count:
1
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Registration date
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2023-07-01, 1402/04/10
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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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2023-06-11, 1402/03/21
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Expected recruitment end date
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2023-07-23, 1402/05/01
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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 self-care model and the developed parallel process model on the burden of care, resilience and self-efficacy of spouses of people with post-war stress vetera(PTSD)
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Public title
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Comparison of two patterns of caregiving and behavior change on burden of care, resilience and self-efficacy of spouses of war veterans.
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Purpose
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Supportive
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Inclusion/Exclusion criteria
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Inclusion criteria:
Spouses of people with post-traumatic stress disorder caused by the blast wave
living with their spouses at the moment
awareness of time and place
Exclusion criteria:
People who do not want to participate in the study
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Age
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No age limit
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Gender
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Female
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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:
80
More than 1 sample in each individual
Number of samples in each individual:
20
The statistical population of all spouses of post-traumatic stress disorder veterans, whose sample size will be selected with G*POWE statistical software, similar articles with a test power of 80%, 15 people in each group
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Randomization will be done in a simple way using the website sealedenvelope.com. Randomization is done by forming blocks of size 6 as follows: ABCCBA - BCABCA - CABACB - BCAACB - CCBABA - BCACBA - BACBAC - BACCAB - BACCBA . Based on the randomization software, the subjects will be grouped in blocks of size six and will be placed in three groups A, B, and C.
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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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2023-05-03, 1402/02/13
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Ethics committee reference number
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IR.IAU.MSHD.REC.1402.018
Health conditions studied
1
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Description of health condition studied
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self efficacy
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ICD-10 code
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ICD-10 code description
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2
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Description of health condition studied
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burden of care
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ICD-10 code
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ICD-10 code description
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3
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Description of health condition studied
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resilience
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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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Self-efficacy score in Domkai questionnaire
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Timepoint
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Self-efficacy questionnaires will be completed first before the intervention and then after 6 training sessions (6 weeks).
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Method of measurement
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Dumkai self-efficacy questionnaire
2
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Description
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burden of care
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Timepoint
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Burden of care questionnaires will be completed first before the start of the intervention and then again after 6 training sessions (6 weeks).
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Method of measurement
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Standard burden of care questionnaire
3
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Description
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Resilience
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Timepoint
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The resilience questionnaire will be completed first before the intervention and then again after 6 training sessions (6 weeks).
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Method of measurement
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Connor and Davidson Resilience Questionnaire
Intervention groups
1
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Description
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Intervention group 1: Before conducting the research, the researcher will explain the purpose of the research to obtain informed consent regarding the safety and anonymity of the research units, and they will be told that they can withdraw from the research even during the study. Then, individual or group sessions will be held at the counseling center of the Shahid Foundation for 45-60 minutes based on the structures of the spiritual self-care model. The spiritual self-care session will consist of six individual training sessions. The content of the sessions will be prepared based on the educational needs of patients and the protocol of similar studies (Omidi, Kazemi and Khatiban, 2014) (Salimi, Garmarodi, Hosseini and Batabi, 2014). Then after the intervention, three questionnaires are completed.
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Category
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N/A
2
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Description
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Intervention group 2: Before conducting the research, while explaining the purpose of the research, the researcher assures the safety and anonymity of the research units. Then, individual or group sessions will be held at the counseling center of Shahid Foundation for 45-60 minutes based on the structures of the developed parallel process model. The parallel process model developed based on model instruments and similar articles will be conducted in six individual or group training sessions. These sessions will be held once a week (30 to 40 minutes) at the foundation or home. Then after the intervention, three The questionnaire is completed
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Category
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N/A
3
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Description
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Control group: This group will receive care and routine consultations of the centers.
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Category
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N/A
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
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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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Yes - There is 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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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available
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Title and more details about the data/document
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Its release schedule is not yet known
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When the data will become available and for how long
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Its release schedule is not yet known
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To whom data/document is available
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Its release schedule is not yet known
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Under which criteria data/document could be used
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Its release schedule is not yet known
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From where data/document is obtainable
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Its release schedule is not yet known
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What processes are involved for a request to access data/document
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Its release schedule is not yet known
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Comments
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6 articles will be extracted from this proposal.