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IRCT20221106056415N1 IRCT 2023-02-07 Yazd University of Medical Sciences Counseling based on mindfulness on pregnancy anxiety of women undergoing in vitro fertilization (IVF) treatment The effect of virtual mindfulness counseling on the level of pregnancy anxiety of women undergoing IVF treatment 2022-12-09 anticipated 56 Complete https://irct.ir/trial/66767 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: The current study is a semi-experimental study of the clinical trial type in a parallel method. In this study, 64 women from eligible mothers referring to the Reproductive Sciences Research Institute will be selected based on the entry and exit criteria using the random number table method using online software (www.Random.org/sequences) and the patients They are assigned to two intervention groups (mindfulness counseling) and control group. Again, each of the groups is divided into two subgroups by a simple random method (4 subgroups of 16 people in two groups). assisted reproductive method) will be investigated, Blinding description: The participants are unaware of the allocation in the study groups. N/A Anxiety during pregnancy of women treated with assisted reproductive methods. Intervention 1: Intervention group: The purpose of mindfulness is that a person who is facing the stress of motherhood can learn meditation based on mindfulness and this makes a person as a mother aware of her emotional reactions and deal with them more skillfully. Mothers receive eight sessions of virtual training on the virtual network in the form of 60 to 90-minute group counseling based on mindfulness once a week. All sessions include a meditation exercise and a three-minute breathing exercise. It begins and ends. The people of the experimental group should do these techniques 3 times a day for 10 minutes each time at home as homework. At the end of the eighth session, Vandenberg pregnancy anxiety questionnaire is completed again by both groups. The follow-up period of this research is one month later, when Vandenberg pregnancy anxiety questionnaire is completed again by both groups. Intervention 2: Control group: Informed and voluntary consent is obtained from the participants. Then, the questionnaire of demographic and gynecological and midwifery characteristics as well as the Vandenberg Pregnancy Anxiety Questionnaire is completed by the participants through Pursline software before the intervention. After the intervention in the intervention group and at the end of the study and if the intervention is effective, educational The control group will be placed. Yes - There is a plan to make this available What will be shared: If the intervention is effective, by applying the information obtained from the research and the application of this method, a solution can be provided to improve mental health and psychological support for pregnant women with a history of infertility and undergoing treatment with assisted reproductive methods. When: Access starts 6 months after results are published To whom: Researchers working in academic institutions Conditions: If the intervention is effective, by applying the information obtained from the research and the application of this method, a solution can be provided to improve mental health and psychological support for pregnant women with a history of infertility and undergoing treatment with assisted reproductive methods. Where to obtain: By correspondence with e-mail fsm171171@gmail.com Fateme Soleimani Monfared How to obtain: After requesting and sending the research and follow-up information, the documents will be sent Comments:
public Fatemeh Solimany Monfared
No8, alley 21 ,Shahid Mohammad Montazeri St., Shahrekord Town
Shahrekord Iran (Islamic Republic of) 8814666686 +98 38 3333 5602 Fatemehzaremobini@yahoo.com Yazd University of Medical Sciences scientific Fatemeh Zaremobini
Yazd, Safiyeh, Timsar Falahi St., Bu Ali St., Infertility Research Center
Yazd Iran (Islamic Republic of) 8814666686 +98 35 3824 1751 Fatemehzaremobini@yahoo.com Yazd University of Medical Sciences Iran (Islamic Republic of) 1- Pregnant women with a history of infertility and treated with assisted reproductive methods 2- Use at least one or more assisted reproductive methods (IVF-IUI-ICSI and...) 3- The ability to use online counseling and have an Android or iOS smart phone 4- Willingness to participate in the study 5- The ability to understand and speak Persian 6- Cooperation in doing homework 7- Having a minimum education at middle school level 8- Pregnancy age 20 weeks and later 20 years 40 years Female Having mental disorders and being treated for mental disorders Simultaneous participation in another study Receiving psychological services at the beginning of the study Having pregnancy-related disorders such as threatened Abortion, Preeclampsia, Threatened premature birth, etc. Suffering from systemic diseases based on the pregnancy record (Chronic diabetes, Chronic hypertension, Thyroid disease, Cardiovascular disease, etc.) Abnormality in the fetus Experiencing a severe mental crisis during the past 6 months, such as the Death of Parents and... Drug and Alcohol addiction Having a disabled child or Having a disabled child in the family Having a history of abortion Existence of severe anxiety based on the Vandenberg questionnaire Treatment - Other Treatment - Other Intervention group: The purpose of mindfulness is that a person who is facing the stress of motherhood can learn meditation based on mindfulness and this makes a person as a mother aware of her emotional reactions and deal with them more skillfully. Mothers receive eight sessions of virtual training on the virtual network in the form of 60 to 90-minute group counseling based on mindfulness once a week. All sessions include a meditation exercise and a three-minute breathing exercise. It begins and ends. The people of the experimental group should do these techniques 3 times a day for 10 minutes each time at home as homework. At the end of the eighth session, Vandenberg pregnancy anxiety questionnaire is completed again by both groups. The follow-up period of this research is one month later, when Vandenberg pregnancy anxiety questionnaire is completed again by both groups. Control group: Informed and voluntary consent is obtained from the participants. Then, the questionnaire of demographic and gynecological and midwifery characteristics as well as the Vandenberg Pregnancy Anxiety Questionnaire is completed by the participants through Pursline software before the intervention. After the intervention in the intervention group and at the end of the study and if the intervention is effective, educational The control group will be placed. Pregnancy anxiety score of women treated with assisted reproductive methods before, immediately and one month after the intervention in two experimental and control groups. Timepoint: The effect of mindfulness counseling in a virtual way on the level of anxiety during pregnancy of women treated with assisted reproductive methods before, immediately and one month after the intervention in two experimental and control groups. Method of measurement: The researcher will select 64 women among pregnant women with a history of infertility and treated with assisted reproductive methods based on the entry and exit criteria using the random number table method using online software (www.Random.org/sequences). And patients are assigned to two intervention groups (mindfulness counseling) and control group. Again, each group is divided into two subgroups by a simple random method (4 subgroups of 16 people in two groups). Informed and voluntary consent is obtained from the participants. Then, the demographic and gynecology and obstetrics questionnaire related to the current pregnancy of the participants, which includes: questions about age, infertility period, gestational age, education level, occupation, spouse's education level, spouse's occupation, adequacy of family income for living expenses, place of residence satisfaction with life, the type of treatment methods and the frequency of treatment failure. Also, Vandenberg Pregnancy Anxiety Questionnaire is completed by the participants of both groups through Prasline software before starting the intervention.Vandenberg pregnancy anxiety questionnaire is completed again by both groups. The follow-up period of this research is one month later, when the Vandenberg pregnancy anxiety questionnaire is completed again by both groups, and then the obtained data are entered and analyzed in the statistical software SPSS version 22. Yazd University of Medical Sciences Approved 2022-10-25 Ethics committee of Yazd University of Medical Sciences No.8,alley 21,Shahid Mohammad Montazeri street,Shahrekord city Shahrekord Chahar-Mahal-va-Bakhtiari Iran (Islamic Republic of)