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IRCT20170611034452N12 IRCT 2020-12-20 Kerman University of Medical Sciences Tele-counselling on perinatal mental health during pandemics Investigating the effectiveness of tele-counselling on perinatal mental health during SARS-COV-2 pandemics 2020-04-20 anticipated 60 Complete https://irct.ir/trial/50289 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Other design features: Education 6 sessions, Twice a week, Randomization description: Randomization in this study is a simple randomization. It is a personal randomization unit. Layering (strata) is not done. Women under the affiliation of health care centres who fill informed consent forms mean that they agree to participate in the study. for the division of them into two groups of intervention and control, statistical software will usedThe tool used in randomization is Randomizer software (www.randomizer.org) which also performs random sequences. َAllocation concealment does not apply to this counselling intervention. N/A Condition 1: anxiety. Condition 2: depression. Condition 3: health anxiety. Intervention 1: Intervention group: Intervention consists of 6 weekly group counselling sessions through virtual networks such as WhatsApp or Skype For 90 to 120 minutes Session Content: 1-Training of how to prevent the COVID-19 and provision of information about the disease, familiarity with practical solutions to a healthy lifestyle according to the condition of women (healthy diet, exercise, adequate sleep), dysfunctional cognitions related to COVID-19, muscle relaxation technique, conscious eating technique, assignment 2-Reviewing assignments, defining mindfulness and its benefits in coping with COVID-19 anxiety, training and performing mindfulness on breathing and senses, expressing personal boundaries and limitations, assignments 3-Review of assignments, familiarity with the physical, mental, emotional, and behavioral symptoms of stress and anxiety, introduction of cognitive errors related to COVID-19 from Ellis and Beck's perspectives, training of ways to overcome pregnancy and postpartum fatigue, training of yoga and aerobic exercise to increase respiratory capacity, assignments 4-Review of assignments, seated meditation with focus on breathing, body sounds and thoughts (four-dimensional meditation), definition of autopilot mind, familiarity with coping styles in the face of stressors, assignments. 5-Reviewing assignments, re-discussing cognitive errors, expressing the disadvantages and advantages of worries and fears, promoting family relationships and making love to the fetus and neonate, defining the pleasant and unpleasant life events, and ways to change feelings and attitudes towards events, assignments. 6-Accepting conditions and commitments by relying on self-care, being at the present (quitting daydreaming), discussing one’s fears about one’s vulnerability to disease, doing a body scan, reviewing and concluding. Intervention 2: Control group: There is no intervention for the control group. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information
public Atefeh Ahmadi
Haft Bagh Square
kerman Iran (Islamic Republic of) 7616913555 +98 34 3132 5179 atefeahmadi59@gmail.com Kerman University of Medical Sciences scientific Atefeh Ahmadi
Haft Bagh Square
kerman Iran (Islamic Republic of) 7616913555 +98 34 3132 5179 atefeahmadi59@gmail.com Kerman University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) satisfaction to participate in the study being in a time period of 28 weeks of pregnancy to 28th postpartum day for women referring for perinatal services Not consuming psychiatric medication no limit no limit Female loss of pregnancy (fetal death) F41 F32.8 F45.8 Other anxiety disorders Other depressive episodes Other somatoform disorders N/A Prevention Intervention group: Intervention consists of 6 weekly group counselling sessions through virtual networks such as WhatsApp or Skype For 90 to 120 minutes Session Content: 1-Training of how to prevent the COVID-19 and provision of information about the disease, familiarity with practical solutions to a healthy lifestyle according to the condition of women (healthy diet, exercise, adequate sleep), dysfunctional cognitions related to COVID-19, muscle relaxation technique, conscious eating technique, assignment 2-Reviewing assignments, defining mindfulness and its benefits in coping with COVID-19 anxiety, training and performing mindfulness on breathing and senses, expressing personal boundaries and limitations, assignments 3-Review of assignments, familiarity with the physical, mental, emotional, and behavioral symptoms of stress and anxiety, introduction of cognitive errors related to COVID-19 from Ellis and Beck's perspectives, training of ways to overcome pregnancy and postpartum fatigue, training of yoga and aerobic exercise to increase respiratory capacity, assignments 4-Review of assignments, seated meditation with focus on breathing, body sounds and thoughts (four-dimensional meditation), definition of autopilot mind, familiarity with coping styles in the face of stressors, assignments. 5-Reviewing assignments, re-discussing cognitive errors, expressing the disadvantages and advantages of worries and fears, promoting family relationships and making love to the fetus and neonate, defining the pleasant and unpleasant life events, and ways to change feelings and attitudes towards events, assignments. 6-Accepting conditions and commitments by relying on self-care, being at the present (quitting daydreaming), discussing one’s fears about one’s vulnerability to disease, doing a body scan, reviewing and concluding. Control group: There is no intervention for the control group Anxiety. Timepoint: Before and 3 weeks after intervention. Method of measurement: Modified to COVID-19 Hospital Depression and Anxiety Scale. Depression. Timepoint: Before and 3 weeks after intervention. Method of measurement: Modified to COVID-19-Hospital Depression and Anxiety Scale. Health anxiety. Timepoint: Before and 3 weeks after intervention. Method of measurement: Health anxiety questionnnaire. Kerman University of Medical Sciences Kerman University of Medical Sciences Kerman University of Medical Sciences Approved 2020-06-19 Deputy of Research Haft Bagh Square kerman Kerman Iran (Islamic Republic of)