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IRCT20170506033834N9 IRCT 2022-01-02 Tabriz University of Medical Sciences Effectiveness of Cognitive Behavioral Therapy and Haptonomy on fear of childbirth, Birth Experiences and postpartum depression in Nulliparous Pregnant Women: A Randomized Controlled Clinical Trial Effectiveness of Cognitive Behavioral Therapy and Haptonomy on fear of childbirth, Birth Experiences and postpartum depression in Nulliparous Pregnant Women: A Randomized Controlled Clinical Trial 2022-01-05 anticipated 99 Complete https://irct.ir/trial/59068 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Participants randomly using RAS software through stratified random blocking based on high and severe fear with 6 and 9 blocks into three groups with a ratio of 1:1:1 (in Each group 33 people) will be assigned. The allocation type will be written on paper and numbered in consecutive opaque envelopes (Allocation Concealment). The envelopes will be opened sequentially by the person not involved in the sampling. N/A Condition 1: Postpartum depression. Condition 2: Fear of childbirth. Intervention 1: Intervention group 1: In the group of cognitive-behavioral intervention from the 24- 28 weeks, counseling in groups of three to six people in eight sessions (combination of face-to-face and online sessions) will be held and each session will be for 45 to 60 minutes, once a week. The content of counseling mainly includes teaching the process of pregnancy and childbirth, expressing the benefits and harms of vaginal birth and cesarean section, teaching the birth stages and process, identifying thoughts, introducing thought, feeling and behavior cycle, providing coping exercises and prevention of inappropriate behaviors and thoughts, training distraction technique, training abdominal breathing, relaxation and Kegel exercises, training in the technique of changing mental images and training to deal with the return of previous behaviors and attitudes. Intervention 2: Intervention group 2: In haptonomy group, communication techniques will be taught from 24 to 28 gestational week, in groups of 3 to 6 people in 5 sessions, a combination of face-to-face and online sessions, each session lasting 45-60 minutes, once a week. The content of intervention mainly includes strengthening positive feelings and attitudes towards pregnancy, identifying worries about pregnancy and childbirth and helping to solve fears and worries, teaching communication methods such as talking to the fetus, observing and touching Abdomen, attention to fetal movements and training fetal movement counting, advice to name the fetus , teaching various methods of controlling labor pain, showing the effect of pregnancy hormones on anatomical changes of the pelvis, helping to change the mind with understanding the pregnancy process and Delivery and evaluation of the birth schedule. Intervention 3: The control group will receive only routine prenatal care. No - There is not a plan to make this available Justification or reason for not sharing IPD is No more data
public Zahra Alivand
Faculty of Nursing and Midwifery, South Shariati StreetTabriz
Tabriz Iran (Islamic Republic of) 5138947977 +98 41 3479 6770 alivand.zahraa@gmail.com Tabriz University of Medical Sciences scientific Roghaiyeh Nourizadeh
Nursing and Midwifery Faculty, South Shariati Street
Tabriz Iran (Islamic Republic of) 041-33808025 +98 41 3479 6770 rnourizadeh@gmail.com Tabriz University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Primiparous women aged 18-45 years Gestational age of 24-28 weeks Fear of childbirth score above 65 18 years 45 years Female History of mental disorders according to the mother statement Known fetal abnormalities Unplanned pregnancy History of participating in physiological birth classes History of recurrent miscarriages or pregnancies with artificial reproductive techniques O90.6 Postpartum mood disturbance Behavior Behavior Behavior Intervention group 1: In the group of cognitive-behavioral intervention from the 24- 28 weeks, counseling in groups of three to six people in eight sessions (combination of face-to-face and online sessions) will be held and each session will be for 45 to 60 minutes, once a week. The content of counseling mainly includes teaching the process of pregnancy and childbirth, expressing the benefits and harms of vaginal birth and cesarean section, teaching the birth stages and process, identifying thoughts, introducing thought, feeling and behavior cycle, providing coping exercises and prevention of inappropriate behaviors and thoughts, training distraction technique, training abdominal breathing, relaxation and Kegel exercises, training in the technique of changing mental images and training to deal with the return of previous behaviors and attitudes. Intervention group 2: In haptonomy group, communication techniques will be taught from 24 to 28 gestational week, in groups of 3 to 6 people in 5 sessions, a combination of face-to-face and online sessions, each session lasting 45-60 minutes, once a week. The content of intervention mainly includes strengthening positive feelings and attitudes towards pregnancy, identifying worries about pregnancy and childbirth and helping to solve fears and worries, teaching communication methods such as talking to the fetus, observing and touching Abdomen, attention to fetal movements and training fetal movement counting, advice to name the fetus , teaching various methods of controlling labor pain, showing the effect of pregnancy hormones on anatomical changes of the pelvis, helping to change the mind with understanding the pregnancy process and Delivery and evaluation of the birth schedule. The control group will receive only routine prenatal care. Fear of childbirth score. Timepoint: Before the intervention in 24-28 gestational week, 35-37 weeks of pregnancy and one month after delivery. Method of measurement: Wijma delivery expectancy/experience questionnaire (versions of A & B). Childbirth experience score. Timepoint: One month after delivery. Method of measurement: Childbirth Experiences Questionnaire version 2.0(CEQ-2.0). Postpartum depression. Timepoint: Before the intervention in 24-28 weeks and one month after delivery. Method of measurement: Edinburgh Postpartum Depression Scale (EPDS). Preferred delivery type. Timepoint: Before the interventions at gestational age of 24-28 weeks and again in 35-37 weeks. Method of measurement: Ask the mother about preferred delivery type. Method of delivery. Timepoint: One month after delivery. Method of measurement: Medical record. Tabriz University of Medical Sciences Approved 2021-11-01 Ethics Committee of Tabriz University of Medical Sciences Faculty of Nursing and Midwifery, South Shariati Street Tabriz East Azarbaijan Iran (Islamic Republic of)