Pregnancy Clinical Trial
Official title:
The Effect of Mindfulness-Based Pregnancy Education Program on Stress, Birth Fear and Birth Self-Efficacy in Pregnants
Verified date | February 2024 |
Source | Inonu University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 84 |
Est. completion date | December 30, 2023 |
Est. primary completion date | October 1, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 50 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Turkey | Faculty of Health Science | Gaziantep | Sahinbey/ Gaziantep |
Lead Sponsor | Collaborator |
---|---|
Inonu University |
Turkey,
Byrne J, Hauck Y, Fisher C, Bayes S, Schutze R. Effectiveness of a Mindfulness-Based Childbirth Education pilot study on maternal self-efficacy and fear of childbirth. J Midwifery Womens Health. 2014 Mar-Apr;59(2):192-7. doi: 10.1111/jmwh.12075. Epub 2013 Dec 10. — View Citation
Fenwick J, Toohill J, Gamble J, Creedy DK, Buist A, Turkstra E, Sneddon A, Scuffham PA, Ryding EL. Effects of a midwife psycho-education intervention to reduce childbirth fear on women's birth outcomes and postpartum psychological wellbeing. BMC Pregnancy Childbirth. 2015 Oct 30;15:284. doi: 10.1186/s12884-015-0721-y. — View Citation
Zemestani M, Fazeli Nikoo Z. Effectiveness of mindfulness-based cognitive therapy for comorbid depression and anxiety in pregnancy: a randomized controlled trial. Arch Womens Ment Health. 2020 Apr;23(2):207-214. doi: 10.1007/s00737-019-00962-8. Epub 2019 Apr 13. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | 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 Aydin et al. The Cronbach alpha coefficient of the scale was found to be 0.82. | Change in Birth Self-Efficacy within 4 weeks | |
Primary | 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 | 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 |
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