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IRCT20180227038879N3 IRCT 2018-12-01 Vice chancellor for Research,Tabriz University Of Medical Sciences The effect of daily family visits on anxiety and depression in pregnant women admitted to hospital Effect of family visit everyday on anxiety and depression in pregnant women with preterm rupture of membranes (PROM) hospitalized in the third trimester of pregnancy. 2018-11-21 anticipated 70 Complete https://irct.ir/trial/33501 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: To hide allocations (Allocation Concealment), Will be written type of intervention on paper and placed inside matte envelopes in numerical order, respectively. The assignment sequence will be performed by a person who has no role in the entry of participants in the research, data collection and analysis of the data. Random Allocation of four and six will be done using the site (http://www.random.org), Blinding description: To hide allocations (Allocation Concealment), Will be written type of intervention on paper and placed inside matte envelopes in numerical order, respectively. The assignment sequence will be performed by a person who has no role in the entry of participants in the research, data collection and analysis of the data. N/A Premature rupture of membranes. Intervention 1: "Intervention group:" In addition to standard care, they will walk each day for half an hour and at least 5 days a week with a spouse or a close family member in the hospital's yard,up to 3 consecutive weeks and at the end of the study if the patients in the intervention group continue to be admitted, It is possible for them to continue the study conditions until delivery and if the delivery is earlier than a week, patients are excluded from the study. Intervention 2: "Control group" will receive all routine care and medication. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is After the completion of the project, the decision will be made
public Fatemeh Abbasalizadeh
Tabriz University Of Medical Sciences., Golgasht Street
Tabriz Iran (Islamic Republic of) 5138665793 +98 41 3553 9161 lahroudin@gmail.com Tabriz University of Medical Sciences scientific Fatemeh Abbasalizadeh
Tabriz University Of Medical Sciences, Golgasht Street
Tabriz Iran (Islamic Republic of) 5138665793 +98 41 3553 9161 lahroudin@gmail.com Tabriz University of Medical Sciences Iran (Islamic Republic of) Women with aged between 20-35 years The desire to participate in the study The possibility of a daily presence of at least 5 days a week for for the patients husband or a close family member in hospital preterm rupture of membranes 20 years 35 years Female Having a history of depression and anxiety Gestational age greater than 38 weeks O42 Premature rupture of membranes Behavior Treatment - Other "Intervention group:" In addition to standard care, they will walk each day for half an hour and at least 5 days a week with a spouse or a close family member in the hospital's yard,up to 3 consecutive weeks and at the end of the study if the patients in the intervention group continue to be admitted, It is possible for them to continue the study conditions until delivery and if the delivery is earlier than a week, patients are excluded from the study. "Control group" will receive all routine care and medication. Depression. Timepoint: At the beginning of the study and the end of the first, second and third weeks of the study. Method of measurement: Depression and Anxiety questionnaire. Anxiety. Timepoint: At the beginning of the study and the end of the first, second and third weeks of the study. Method of measurement: Depression and Anxiety questionnaire. Vice chancellor for Research,Tabriz University Of Medical Sciences Approved 2018-08-27 Ethics Committee Of Tabriz University Of Medical Sciences Third Floor., Central Building of Number2., Golgasht Street Tabriz East Azarbaijan Iran (Islamic Republic of)