The Effect of Mindfulness-Based Pregnancy Education Program on Stress, Birth Fear and Birth Self-Efficacy in Pregnants

Study Overview
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Brief Summary
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The research will be carried out to determine the effect of mindfulness-based pregnancy education program on stress, fear of childbirth and birth self-efficacy in pregnant women. The study was designed as a randomized controlled trial. The universe of the research will consist of pregnant women who applied to Gaziantep Cengiz Gökçek Gynecology and Pediatrics Hospital Pregnancy training class. The sample of the research, on the other hand, was determined by power analysis, at least the number of individuals to be included in the sample of the research. Sample size when power analysis is done; Assuming that the method applied with 5% error level, bidirectional significance level, 95% confidence interval and 80% ability to represent the universe, would reduce the anxiety score averages (30.53±6.49) by 4 points, a total of 84 pregnant women (42 experimental, 42 control) were calculated. Introductory Information Form, Prenatal Distress Scale (PBL)-Revised Version, Birth Attitude Scale and Birth Self-Efficacy Scale short form will be used. It is predicted that the research will contribute to the literature in line with its originality and results.

Detailed Description
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The research will be carried out to determine the effect of mindfulness-based pregnancy education program on stress, fear of childbirth and birth self-efficacy in pregnant women. The study was designed as a randomized controlled trial. The universe of the research will consist of pregnant women who applied to Gaziantep Cengiz Gökçek Gynecology and Pediatrics Hospital Pregnancy training class. The sample of the research, on the other hand, was determined by power analysis, at least the number of individuals to be included in the sample of the research. Sample size when power analysis is done; Assuming that the method applied with 5% error level, bidirectional significance level, 95% confidence interval and 80% ability to represent the universe, would reduce the anxiety score averages (30.53±6.49) by 4 points, a total of 84 pregnant women (42 experimental, 42 control) were calculated. Introductory Information Form, Prenatal Distress Scale (PBL)-Revised Version, Birth Attitude Scale and Birth Self-Efficacy Scale short form will be used. Pregnant Information Form: It is a form consisting of 21 questions developed by the researchers in line with the literature in order to determine the socio-demographic, obstetric and health characteristics of women. Prenatal Distress Scale (PBL)- Revised Version The Prenatal Distress Scale was developed by Yali and Lobel in 1999 to assess women's social relations, physical and emotional symptoms, and concerns about themselves and their baby during pregnancy (14). The first 12-item scale was developed by Lobel in 2008 and a 17-item Prenatal Distress - Revised version was created (15). The Turkish validity and reliability study was performed by Yüksel et al. in 2011 (16). In the internal consistency analysis of the scale (n=522), the Cronbach's alpha internal consistency coefficient was 0.85, and the item 36 total score correlation coefficients (r) ranged from 0.20 to 0.78 (p<0.001). The scale is in 3-point Likert type. The participants are asked to read the statement in the scale and choose the one that suits them from the sequential statements Not at all (0), A little (1) and Too much (2). The minimum score that can be obtained from the scale is 0 and the maximum score is 34, and as the score obtained from the scale increases, prenatal distress levels also increase. The scale has no breakpoints. Birth Attitude Scale Birth attitude scale is a scale developed by Lowe to measure fear of birth. This scale is a four-point Likert scale consisting of 16 items, with a high score indicating high anxiety. 1= No worries; no fear, 2= Low anxiety; not enough to be called fear, 3= moderate anxiety; distressing but enough to affect feelings of well-being 4 = high anxiety; It is evaluated as very worrying and affecting the sense of well-being. The Cronbach alpha coefficient of the scale, which was performed by Dönmez et al. in 2012, was found to be 0.82. Birth Self-Efficacy Scale Short form The Birth Self-Efficacy Scale, consisting of 28 items, has two sub-dimensions as result expectation and self-efficacy expectation, scored from 1 to 10, 1 = 'I'm NOT SURE' 10 = 'TOTALLY SURE'. The lowest score that can be obtained from the scale is 28, the lowest The high score is 280, and it is accepted that as the score increases, birth self-efficacy increases, and as the score decreases, it decreases. Its Turkish validity and reliability were evaluated in 2021 by Aydın et al. The Cronbach alpha coefficient of the scale was found to be 0.82. Data Collection: The data will be interviewed and invited by the researchers to the pregnant women who applied to the pregnant training class at Gaziantep Cengiz Gökçek Gynecology and Childhood Hospital between July 2022 and December 2022. Pregnant women who accept to participate in the study and meet the criteria will be filled by the researchers by face-to-face interview method. As a pre-test, Descriptive Information Form, Prenatal Distress Scale (PBL) - Revised Version, Birth attitude scale and birth self-efficacy scale - short form will be applied to the pregnants in the experimental and control groups. After the conscious awareness-based pregnancy education program was applied to the experimental group, 2 sessions a week for 4 weeks (1 month), a total of 8 sessions, the Prenatal Distress Scale (PBL) - Revised Version, Birth Attitude Scale was applied to the experimental group and simultaneously to the control group. and 'birth self-efficacy scale-short form' will be applied. They will receive the pregnant training given in the routine pregnant class. It is predicted that the research will contribute to the literature in line with its originality and results.

Official Title
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The Effect of Mindfulness-Based Pregnancy Education Program on Stress, Birth Fear and Birth Self-Efficacy in Pregnants

Conditions
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Mindfulness, Pregnancy, Stress, Childbirth, Midwife

Intervention / Treatment
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* Behavioral: mindfulness-based pregnancy education program.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Not having any diagnosed psychiatric disease, Able to read and write, Using a smart phone, with internet access Having a headset accessory for phone calls, Pregnant women who voluntarily agreed to participate in the study Exclusion Criteria: Pregnant women with communication barriers and mental disabilities Pregnant women under the age of 18

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MBSR group<br>mindfulness-based pregnancy education program group | Behavioral: mindfulness-based pregnancy education program.<br>* Pregnant education program based on mindfulness is planned as 2 sessions per week for 4 weeks, in total 8 sessions. Each session is planned to last 40-60 minutes on average. Sessions will continue as individu<br>|
| No Intervention: Control group<br>control group standard care group | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prenatal Distress Scale (PBL)- Revised Version | The Prenatal Distress Scale was developed by Yali and Lobel in 1999 to assess women's social relations, physical and emotional symptoms, and concerns about themselves and their baby during pregnancy (14). The first 12-item scale was developed by Lobel in 2008 and a 17-item Prenatal Distress - Revised version was created (15). The Turkish validity and reliability study was performed by Yüksel et al. in 2011 (16). In the internal consistency analysis of the scale (n=522), Cronbach's alpha internal consistency coefficient was 0.85, and item 36 total score correlation coefficients (r) ranged from 0.20 to 0.78 (p<0.001). The scale is 3-point Likert type. | Change in stress at 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Birth Attitude Scale | The birth attitude scale is a scale developed by Lowe to measure the fear of birth. This scale is a four-point Likert scale consisting of 16 items, with a high score indicating high anxiety. 1= No worries; no fear, 2= Low anxiety; not enough to be called fear, 3= moderate anxiety; distressing but enough to affect feelings of well-being 4 = high anxiety; It is evaluated as very worrying and affecting the sense of well-being. The Cronbach alpha coefficient of the scale, which was performed by Dönmez et al. in 2012, was found to be 0.82. | Change in Birth Attitude within 4 weeks |