Protocol summary
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Study aim
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Determining the effect of virtual mindfulness-based counseling on the level of anxiety during pregnancy of women treated with assisted reproductive methods
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Design
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The current study is a semi-experimental study of the clinical trial type with a parallel method and a control group on a sample size of 64 people (32 people in each group) using the random number table method using online software (www.Random .org/sequences) will be selected.
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Settings and conduct
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Referring to Yazd Reproductive Sciences Research Institute, 64 women were selected pregnant women with a history of infertility and treated with assisted reproductive methods based on the entry and exit criteria, and the patients were assigned to two intervention and control groups. The test group will receive eight training sessions in the form of 60 to 90-minute group counseling based on mindfulness.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: gestational age of 20 weeks or later, pregnant women with a history of infertility and being treated with assisted reproductive methods, using at least one or more assisted reproductive methods (IVF-IUI-ICSI, etc.), exclusion criteria: having a history Miscarriage, severe anxiety according to the Vandenberg questionnaire, having mental disorders and being treated for mental disorders
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Intervention groups
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After dividing into two groups, people will complete the study questionnaires .The Intervention group receives eight virtual training sessions in the form of 60 to 90-minute group counseling based on mindfulness once a week.At the end of the eighth session, Vandenberg pregnancy anxiety questionnaire is completed again by both groups.
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Main outcome variables
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Comparing the mean Score 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.
General information
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Reason for update
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Wrong registration of the scientific title of the trial
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20221106056415N1
Registration date:
2023-02-07, 1401/11/18
Registration timing:
retrospective
Last update:
2023-09-26, 1402/07/04
Update count:
1
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Registration date
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2023-02-07, 1401/11/18
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2022-12-09, 1401/09/18
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Expected recruitment end date
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2023-01-08, 1401/10/18
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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The effect of virtual mindfulness counseling on the level of pregnancy anxiety of women undergoing IVF treatment
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Public title
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Counseling based on mindfulness on pregnancy anxiety of women undergoing in vitro fertilization (IVF) treatment
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Purpose
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Education/Guidance
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Inclusion/Exclusion criteria
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Inclusion criteria:
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
Exclusion criteria:
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
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Age
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From 20 years old to 40 years old
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Gender
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Female
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Phase
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N/A
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Groups that have been masked
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Sample size
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Target sample size:
56
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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The participants are unaware of the allocation in the study groups
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2022-10-25, 1401/08/03
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Ethics committee reference number
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IR.SSU.REC.1401.055
Health conditions studied
1
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Description of health condition studied
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Anxiety during pregnancy of women treated with assisted reproductive methods
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ICD-10 code
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ICD-10 code description
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Primary outcomes
1
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Description
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Pregnancy anxiety score of women treated with assisted reproductive methods before, immediately and one month after the intervention in two experimental and control groups
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Timepoint
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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.
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Method of measurement
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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.
Intervention groups
1
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Description
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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.
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Category
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Treatment - Other
2
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Description
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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.
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Category
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Treatment - Other
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Yazd University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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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.
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When the data will become available and for how long
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Access starts 6 months after results are published
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To whom data/document is available
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Researchers working in academic institutions
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Under which criteria data/document could be used
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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.
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From where data/document is obtainable
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By correspondence with e-mail fsm171171@gmail.com
Fateme Soleimani Monfared
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What processes are involved for a request to access data/document
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After requesting and sending the research and follow-up information, the documents will be sent
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Comments
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