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IRCT20111219008459N12 IRCT 2018-11-10 Tabriz University of Medical Sciences The effect of counseling on perceived stress in pregnant women with a history of primary infertility The effect of counseling with cognitive-behavioral approach on perceived stress in pregnant women with a history of primary infertility: a randomized controlled clinical trial 2018-11-11 anticipated 56 Complete https://irct.ir/trial/34677 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: The participants are divided into intervention and control groups using randomized block design according to their age (20 to 30, and 31 to 40 years old), with a block size of 4 and 6.In order to hide the allocation, the type of intervention will be written on paper and placed in matt and packed envelopes numbered.The envelopes will be opened in the order of participation of the participants and the type of group will be determined. N/A perceived stress. Intervention 1: For the intervention group (n=28), cognitive-behavioral group counseling will be conducted at 6 in-person sessions of 60-90 min each, besides two telephone sessions once a week. Intervention 2: The controls (n=28) will receive only the routine pregnancy care. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information.
public Farideh Golshani
Faculty of Nursing Midwifery, South Shariati Street
Tabriz Iran (Islamic Republic of) 5168743953 +98 41 3479 6770 F.golshani53@gmail.com Tabriz University of Medical Sciences scientific Shirin Hasanpour
Nursing and Midwifery Faculty,South Shariaty Street
Tabriz Iran (Islamic Republic of) 5168743953 +98 41 3479 6770 shirinhasanpoor@yahoo.com Tabriz University of Medical Sciences Iran (Islamic Republic of) Age between 20 and 40 years The history of primary infertility at least secondary education Gestational age between the beginning of the 14th week and the end of the 20th week 20 years 40 years Female Abnormalities in the fetus The history of self-reported mental illness The history of self-reported chronic physical illness (heart disease, hypertension, pulmonary disease, iron deficiency anemia, diabetes, thyroid disease, epilepsy) The history of severe self-reported psychological crisis over the past 3 months, such as the death of relatives Other Other For the intervention group (n=28), cognitive-behavioral group counseling will be conducted at 6 in-person sessions of 60-90 min each, besides two telephone sessions once a week The controls (n=28) will receive only the routine pregnancy care. Perceived Stress. Timepoint: Before the intervention and four weeks after the intervention. Method of measurement: Kohen perceived stress questionnaire. Anxiety. Timepoint: Before the intervention and four weeks after the intervention. Method of measurement: PRAQ: Pregnancy related anxiety questionnaire. Depression. Timepoint: Before the intervention and four weeks after the intervention. Method of measurement: Edinburghs Depression during Pregnancy questionnaire. Quality of life. Timepoint: Before the intervention and four weeks after the intervention. Method of measurement: QOL-GRAV: Quality of life gravidarum. Tabriz University of Medical Sciences Approved 2018-10-22 Ethics committee of Tabriz University of Medical Sciences Research department, third floor,central construction number 2 , Tabriz University of Medical Sciences , Golgasht Street, Azadi Avenue ,Tabriz Tabriz East Azarbaijan Iran (Islamic Republic of)