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IRCT20200923048813N1 IRCT 2020-11-15 Qazvin University of Medical Sciences Evaluation of multifaceted intervention on the health of divorced female-headed households Multifaceted Intervention Based on Theory of health Action Process Approach to the Health of Divorced female headed-households: Protocol of a Controlled Randomized Trial 2021-01-20 anticipated 100 Complete https://irct.ir/trial/51164 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Random allocation of participants in two groups will be done by random blocking method with 4 blocks. The block randomization method is such that the allocation sequence is written before the start of the research. Given that the two groups will be studied, 4 blocks are used and each letter is assigned to a group (A: intervention group: B control group). All possible modes are written and numbered for a block of 4. Then, in a simple random method (using a table of random numbers), a number of numbers are selected from the block numbers and by writing the contents of the blocks related to those numbers (until the specified sample size is reached), The random assignment sequence is specified, Blinding description: The analyzer does not know about the groups. 3 Divorced female headed-households`health. Intervention 1: Intervention group: Training with HAPA and CBT Family model for 6 weeks through face-to-face , online with and without application training. Intervention sessions: Interventional training sessions will be designed both in person and offline training application. In this application, approved educational materials in The mentioned areas will be included.content of Education will be evaluated in terms of general criteria such as accuracy, non-contradiction and integrity, clarity, appropriateness to the audience, attractiveness, acceptability and creativity, as well as the content presented in terms of content and presentation of the message. Will take.Educational materials designed before the intervention will be provided to 10 divorced women apart from the sample size to be evaluated in terms of comprehensibility and acceptability. Interventions for divorced women with inclusion criteria will be performed and in the control group will receive only individual cognitive-behavioral training program and two training pamphletsBefore starting the study, in a 2-hour training class, the intervention group and the control group will be taught separately how to work with the application, and the researcher will provide people with their phones to answer any type of question related to the application or other questions. Educational items designed in a very simple and understandable way for clients.CBT Family / CBT training interventions are prepared in three ways online and in the application in the form of video and writing and event recording that at any time a person can use any of the methods that are possible for him. Interventions after 2 hours of application training for Members of the intervention group beginCBT Family training will done in 6 sessions of 1.5 hours and also providing educational package content interventions (educational pamphlet and CD) for the field of reproductive health (breast cancer screening) and 1 45-minute CBT session and educational pamphlet (breast cancer screening) Will receive the control group.The training content is designed based on the Health Action Process Approach model in six half-hour sessions on CD and application in which three training sessions for risk perception structures, expectation of results in the HAPA (Health Action Process Approach) motivational phase and three sessions for the structure Self-efficacy of self-efficacy is designed and the level of awareness before and after training will be completed by the researcher-made questionnaire and checklist made by the individual.Awareness before and after training will be completed by the individual using a questionnaire and a researcher-made checklist. And CBT Family evaluation will be done by recording the data in the application using the standard HADS questionnaire and the adaptation and continuity assessment scale of 3 or 4 FACES family. Finally, the results obtained in the two groups of intervention and control are compared immediately after the intervention and three months after the intervention. First sessions: Familiarity with the participant and explanation of the program Second sessions: Educate the participant about the cognitive-behavioral approach with emphasis on communication skillsThird sessions: Familiarity with negative thoughts and ideas and mental stereotypes about the occurrence of social behaviors and the degree of belief in these thoughtsFourth sessions: Familiarity with spontaneous thoughts in dealing with family and communityFifth sessions: Examining the evidence confirming and rejecting negative beliefs about behavior in the familySixth sessions: Functional analysis and establishing a therapeutic relationshipHAPA-based breast self-examination structures- Action Self-efficacy: Be optimistic about doing the breast self-examination correctly- Outcome expectations: life span And increase the level of reproductive health in the family- Risk perception: Breast loss due to cancer and family loss as well as the prevalence of overhead breast cancer in women- Behavioral intention: Enough motivation to do monthly breast self-examination- Action Plan: Set the schedule and the order of the examination by the person herself- Coping plan: Schedule a proper monthly breast self-examination by the person in the presence of the researcher to ensure that it is done correctly- Self-efficacy: Perform proper breast self-examination by the individualContent of breast self-examination training sessions in the training package (30 minutes each session):- First session: Importance of breast self-examination Meet women and get their awareness of breast cancer risk and its consequences and their awareness of breast cancer screening Risk of late detection of breast cancer and its impact on quality of life and longevity- Second session: The effect of breast self-examination on quality of life Show death statistics for breast cancer Show slides of breast cancer surgeries and their impact on beauty and quality of life and longevity of women- Third session: Preparation of schedule and schedule of breast self-examination by a woman How to plan a monthly breast self-examination during the menstrual cycle or after menopause- Fourth session: Perform breast self-examination in order and step by step from observation to accurate touching of different parts of the breast- Fifth session: Breast self-examination with the help of the researcher's instructions, first all the steps of observation and then the touch stage in two positions in a supine position and then the right lymph nodes and relying on abnormal points that may be found in the examination - practice and eliminate Find out the objections of the researcher and answer the questions and concerns of women- Sixth session: Perform step by step Breast examination View to touch the tissue To examine the lymph nodes Repeat until the stage is done without any problems and completely correct and record the problems related to the examination in each stage in a sheet.Family for 6 weeks through face-to-face training, practical application. Intervention 2: Control group: Get a brief pamphlet and CBT education in one session (1.5 hour). Yes - There is a plan to make this available What will be shared: All data can be shared in the form of an article or protocol after unidentifiable When: one year after article published To whom: students and masters Conditions: only with refernce Where to obtain: Qazvin university of medical sciences How to obtain: request to deputy of research Qazvin university of medical sciences Comments:
public Farzaneh Golboni
S EIslamic Republic of Iran Ministry of Health & Medical Education A bolck -6 floor Eyvanak Shahrak Gharb Tehran -
Tehran Iran (Islamic Republic of) ۱۴۱۹۹۴۳۴۷۱ +98 21 8145 4462 f.golboni@behdasht.gov.ir Qazvin University of Medical Sciences scientific Farzaneh Golboni
Ministry of health and medical education- 6 floor - -East Eyvanak- Shahrak Gharb- Tehran
Tehran Iran (Islamic Republic of) ۱۴۱۹۹۴۳۴۷۱ +98 21 8145 4462 f.golboni@behdasht.gov.ir Qazvin University of Medical Sciences Iran (Islamic Republic of) Divorced female headed-households covered by welfare Having children No history of severe mental illness and addiction Having Smart phone Willing to participate 20 years 60 years Female Drugs or psychotropic substances abuse Use of psychiatric drugs Participate in cognitive sessions or similar training sessions Behavior Behavior Intervention group: Training with HAPA and CBT Family model for 6 weeks through face-to-face , online with and without application training. Intervention sessions: Interventional training sessions will be designed both in person and offline training application. In this application, approved educational materials in The mentioned areas will be included.content of Education will be evaluated in terms of general criteria such as accuracy, non-contradiction and integrity, clarity, appropriateness to the audience, attractiveness, acceptability and creativity, as well as the content presented in terms of content and presentation of the message. Will take.Educational materials designed before the intervention will be provided to 10 divorced women apart from the sample size to be evaluated in terms of comprehensibility and acceptability. Interventions for divorced women with inclusion criteria will be performed and in the control group will receive only individual cognitive-behavioral training program and two training pamphletsBefore starting the study, in a 2-hour training class, the intervention group and the control group will be taught separately how to work with the application, and the researcher will provide people with their phones to answer any type of question related to the application or other questions. Educational items designed in a very simple and understandable way for clients.CBT Family / CBT training interventions are prepared in three ways online and in the application in the form of video and writing and event recording that at any time a person can use any of the methods that are possible for him. Interventions after 2 hours of application training for Members of the intervention group beginCBT Family training will done in 6 sessions of 1.5 hours and also providing educational package content interventions (educational pamphlet and CD) for the field of reproductive health (breast cancer screening) and 1 45-minute CBT session and educational pamphlet (breast cancer screening) Will receive the control group.The training content is designed based on the Health Action Process Approach model in six half-hour sessions on CD and application in which three training sessions for risk perception structures, expectation of results in the HAPA (Health Action Process Approach) motivational phase and three sessions for the structure Self-efficacy of self-efficacy is designed and the level of awareness before and after training will be completed by the researcher-made questionnaire and checklist made by the individual.Awareness before and after training will be completed by the individual using a questionnaire and a researcher-made checklist. And CBT Family evaluation will be done by recording the data in the application using the standard HADS questionnaire and the adaptation and continuity assessment scale of 3 or 4 FACES family. Finally, the results obtained in the two groups of intervention and control are compared immediately after the intervention and three months after the intervention. First sessions: Familiarity with the participant and explanation of the program Second sessions: Educate the participant about the cognitive-behavioral approach with emphasis on communication skillsThird sessions: Familiarity with negative thoughts and ideas and mental stereotypes about the occurrence of social behaviors and the degree of belief in these thoughtsFourth sessions: Familiarity with spontaneous thoughts in dealing with family and communityFifth sessions: Examining the evidence confirming and rejecting negative beliefs about behavior in the familySixth sessions: Functional analysis and establishing a therapeutic relationshipHAPA-based breast self-examination structures- Action Self-efficacy: Be optimistic about doing the breast self-examination correctly- Outcome expectations: life span And increase the level of reproductive health in the family- Risk perception: Breast loss due to cancer and family loss as well as the prevalence of overhead breast cancer in women- Behavioral intention: Enough motivation to do monthly breast self-examination- Action Plan: Set the schedule and the order of the examination by the person herself- Coping plan: Schedule a proper monthly breast self-examination by the person in the presence of the researcher to ensure that it is done correctly- Self-efficacy: Perform proper breast self-examination by the individualContent of breast self-examination training sessions in the training package (30 minutes each session):- First session: Importance of breast self-examination Meet women and get their awareness of breast cancer risk and its consequences and their awareness of breast cancer screening Risk of late detection of breast cancer and its impact on quality of life and longevity- Second session: The effect of breast self-examination on quality of life Show death statistics for breast cancer Show slides of breast cancer surgeries and their impact on beauty and quality of life and longevity of women- Third session: Preparation of schedule and schedule of breast self-examination by a woman How to plan a monthly breast self-examination during the menstrual cycle or after menopause- Fourth session: Perform breast self-examination in order and step by step from observation to accurate touching of different parts of the breast- Fifth session: Breast self-examination with the help of the researcher's instructions, first all the steps of observation and then the touch stage in two positions in a supine position and then the right lymph nodes and relying on abnormal points that may be found in the examination - practice and eliminate Find out the objections of the researcher and answer the questions and concerns of women- Sixth session: Perform step by step Breast examination View to touch the tissue To examine the lymph nodes Repeat until the stage is done without any problems and completely correct and record the problems related to the examination in each stage in a sheet.Family for 6 weeks through face-to-face training, practical application Control group: Get a brief pamphlet and CBT education in one session (1.5 hour) Self breast examination. Timepoint: Immediately after the intervention and 3 month later. Method of measurement: check list. Depression and anxiety. Timepoint: Immediately after the intervention and 3 month later. Method of measurement: Questionnaire standard of HOST. Family adaption. Timepoint: Immediately after the intervention and 3 month later. Method of measurement: FACE 3 Questionnaire. Qazvin University of Medical Sciences Approved 2020-07-29 Ethics committee of Qazvin University of Medical Sciences QAZVIN UNIVERSITY OF MEDICAL SCIENCES -BAHONAR BLV QAZVIN Qazvin Iran (Islamic Republic of)