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IRCT20160619028528N5 IRCT 2021-11-28 Mazandaran University of Medical Sciences The Effect of Mindfulness-Based Art therapy on Sever Fear of Childbirth in Nulliparous Women: A randomized controlled clinical trial Comparison of the Effect of Mindfulness-based Art therapy and Routine Care on Severe Fear of Childbirth in Nulliparous Women 2021-10-23 anticipated 58 Complete https://irct.ir/trial/59084 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Other, Purpose: Supportive, Randomization description: Blocked random allocation method will be used for random assignment of samples to two intervention groups (mindfulness-based art therapy) and control group (routine care). For this purpose, quadruple blocks will be considered. The six blocks may be TCTTCC, CTTC, CTCT, CCTT, TCTC, TCCT, with T being for the intervention group and C for the control group. The randbetween function in Excel will be used to randomly select blocks. Production numbers will be between 1 and 6 and will be selected based on the production number of the desired block and all 4 samples will be assigned to the intervention and control group, Blinding description: Due to the nature of the intervention, it will not be possible to keep the participants and the researcher responsible for the intervention blind during the intervention process. Therefore, in order to control the blinding bias at the evaluator level (detection bias), the blinding process will be performed on the people who are responsible for collecting information and analyzing data. 3 Fear of childbirth in nulliparous women. Intervention 1: Intervention group: The intervention is mindfulness-based art therapy, which will be performed by a Master of Midwifery Counseling in 8 sessions in women with a "gestational age" of 26-26 weeks. Group meetings are held for 4 weeks (2 sessions per week). Each session will take 90 minutes. The groups will be 3-5 people. The research team includes a reproductive health specialist, a reproductive epidemiologist, a psychiatrist, a clinical psychologist, an art therapist, and a graduate student in midwifery counseling who will assist in the design and implementation of the protocol. The content of the program of the present research sessions is as follows: 1. Familiarity with mindfulness technique, exploring the relationship between mind and body and understanding pregnancy and the existence of a child 2. Recognizing and accepting their feelings by focusing on feelings about childbirth and child 3. Recognizing and understanding the feelings and perceptions about the birth process 4. Recognizing and understanding the feelings towards the baby 5. Recognizing and understanding the feelings and perceptions about parenting 6. Recognizing and understanding the feelings and perceptions towards the delivery room and staff 7. Recognizing perceptions related to the person's self-confidence and abilities, recognizing obstacles in order to help him on the journey to delivery 8. Recognizing and understanding the feelings and perceptions of the person Life after childbirth. Content validity of the protocol of this 8-session program will be reviewed by relevant experts (psychiatrist, psychologist, art therapist, reproductive health specialist, gynecologist). In these sessions, techniques of painting, collage and working with clay or dough will be used. The tools used in this research include painting supplies such as paper, crayons, watercolors and pastels, and collage supplies such as cardboard, pieces of fabric, newspapers, magazines, photographs, disposables, glue and clay or dough. Exercises are also considered as homework. This protocol is implemented practically in Iran and its effect on the study outcome (fear of childbirth) will be calculated through indicators such as the Effect Size index. Intervention 2: Control group: Women in the control group will receive routine prenatal care (Prenatal periodic visits). After completing the last questionnaire (four weeks after the intervention), in order to enjoy the benefits of the study, a mindfulness-based art therapy session will be held for the control group participants and their possible questions about fear of childbirth will be answered. 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 There is no further information
public Kosar Miraei Mohammadi
Piroozi Alley 12, Piroozi St., Taleghani Blvd.
Sari Iran (Islamic Republic of) 48187-68977 +98 11 3310 6053 kosarmohammadi1371@gmail.com Mazandaran University of Medical Sciences scientific Dr. Zeinab Hamzehgardeshi
Nasibeh Nursing and Midwifery Faculty, Amir Mazandarani Street
Sari Iran (Islamic Republic of) 48431-63181 009833367342 z.hamzehgardeshi@mazums.ac.ir Mazandaran University of Medical Sciences Iran (Islamic Republic of) Nulliparous Women Gestational age 28-26 weeks Wijma Delivery Expectancy Questionnaire (W-DEQ-A) score from 66 to 100 Single pregnancy Living together with a spouse Iranian nationality Persian language Having a written consent to participate in the research no limit no limit Female High-risk pregnancy Getting pregnant through assisted reproductive techniques Repeated abortion experience (2 times or more) History of psychiatric illness (schizophrenia, bipolar disorder, and major depression) or get it at the time of the study by self-report or registration in the medical record Use of psychiatric drugs (such as antidepressants, anti-anxiety and anti-psychotic drugs), drug abuse, alcohol and psychotropic drugs Chronic physical illness (diabetes, cardiovascular disease, kidney disease, self-report or registration in the medical record) Receive other treatments or participate in other interventions (types of interventions including behavioral therapy, cognitive-behavioral therapy, psycho-education, etc.) to control stress, anxiety and fear Treatment - Other Treatment - Other Intervention group: The intervention is mindfulness-based art therapy, which will be performed by a Master of Midwifery Counseling in 8 sessions in women with a "gestational age" of 26-26 weeks. Group meetings are held for 4 weeks (2 sessions per week). Each session will take 90 minutes. The groups will be 3-5 people. The research team includes a reproductive health specialist, a reproductive epidemiologist, a psychiatrist, a clinical psychologist, an art therapist, and a graduate student in midwifery counseling who will assist in the design and implementation of the protocol. The content of the program of the present research sessions is as follows: 1. Familiarity with mindfulness technique, exploring the relationship between mind and body and understanding pregnancy and the existence of a child 2. Recognizing and accepting their feelings by focusing on feelings about childbirth and child 3. Recognizing and understanding the feelings and perceptions about the birth process 4. Recognizing and understanding the feelings towards the baby 5. Recognizing and understanding the feelings and perceptions about parenting 6. Recognizing and understanding the feelings and perceptions towards the delivery room and staff 7. Recognizing perceptions related to the person's self-confidence and abilities, recognizing obstacles in order to help him on the journey to delivery 8. Recognizing and understanding the feelings and perceptions of the person Life after childbirth. Content validity of the protocol of this 8-session program will be reviewed by relevant experts (psychiatrist, psychologist, art therapist, reproductive health specialist, gynecologist). In these sessions, techniques of painting, collage and working with clay or dough will be used. The tools used in this research include painting supplies such as paper, crayons, watercolors and pastels, and collage supplies such as cardboard, pieces of fabric, newspapers, magazines, photographs, disposables, glue and clay or dough. Exercises are also considered as homework. This protocol is implemented practically in Iran and its effect on the study outcome (fear of childbirth) will be calculated through indicators such as the Effect Size index. Control group: Women in the control group will receive routine prenatal care (Prenatal periodic visits). After completing the last questionnaire (four weeks after the intervention), in order to enjoy the benefits of the study, a mindfulness-based art therapy session will be held for the control group participants and their possible questions about fear of childbirth will be answered. Fear of childbirth. Timepoint: At the time of enrollment - immediately after the intervention - one month after the intervention. Method of measurement: Wijma Delivery Expectancy/ Experience Questionnaire (W-DEQ-A). Childbirth self-efficacy. Timepoint: At the time of enrollment - immediately after the intervention - one month after the intervention. Method of measurement: Iranian Childbirth Self-Efficacy Inventory (ICBSEI-36). Mindfulness. Timepoint: At the time of enrollment - immediately after the intervention - one month after the intervention. Method of measurement: Five Factor Mindfulness Questionnaire (FFMQ). Preferred childbirth method. Timepoint: At the time of enrollment - immediately after the intervention - one month after the intervention. Method of measurement: Socio-demographic-fertility Characteristics. Treatment (Intervention) Adherence. Timepoint: One month after the intervention. Method of measurement: 3 criteria for adherence to the intervention: the number of mindfulness-based art therapy sessions that women participate in the intervention group, the number of participants who do their homework and the number of participants who complete the questionnaires completely. Treatment (Intervention) Satisfaction. Timepoint: One month after the intervention. Method of measurement: Satisfaction Visual Analog Scale. Mazandaran University of Medical Sciences Approved 2021-10-02 Ethics committee of Mazandaran University of Medical Sciences Moallem Square, Vice Chancellor for Research and Technology, Mazandaran University of Medical Sciences Sari Mazandaran Iran (Islamic Republic of)