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

NCT05507307 | Completed

• 1 other identifier: 117.17.06
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Mindfulness; Pregnancy; Stress; Childbirth; Midwife

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Birth Attitude Scale

  Change in Birth Attitude within 4 weeks

Other Outcomes (1)

• Birth Self-Efficacy Scale Short form

  Change in Birth Self-Efficacy within 4 weeks

Study Arms (2)

MBSR group

EXPERIMENTAL

mindfulness-based pregnancy education program group

Behavioral: mindfulness-based pregnancy education program.

Control group

NO INTERVENTION

control group standard care group

Interventions

mindfulness-based pregnancy education program. BEHAVIORAL

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

MBSR group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Pregnant women with communication barriers and mental disabilities
• Pregnant women under the age of 18

Sponsors & Collaborators

• Inonu University: lead

Study Sites (1)

Faculty of Health Science

Gaziantep, Şahinbey/ Gaziantep, 27010, Turkey (Türkiye)

Location

Related Publications (3)

• 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.

  PMID: 24325752 BACKGROUND

• 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.

  PMID: 30982086 BACKGROUND

• 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.

  PMID: 26518597 BACKGROUND

Study Officials

• Sıdıka Özlem CENGİZHAN, Assistant Professor

  Gaziantep Islamic Science and Technology University faculty of health sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Randomized
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Randomized

Study Record Dates

• First Submitted: August 17, 2022
• First Posted: August 18, 2022
• Study Start: August 17, 2022
• Primary Completion: October 1, 2023
• Study Completion: December 30, 2023
• Last Updated: February 13, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)