NCT07189767

Brief Summary

The aim of this study is to evaluate the effects of a prenatal psychoeducation program applied to pregnant women with a traumatic perception of birth on the perception of traumatic birth, maternal attachment, breastfeeding and postpartum depression.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 6, 2023

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 26, 2024

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 7, 2024

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

August 14, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 24, 2025

Completed
Last Updated

September 24, 2025

Status Verified

September 1, 2025

Enrollment Period

1.1 years

First QC Date

August 14, 2025

Last Update Submit

September 23, 2025

Conditions

Keywords

traumatic birthpsychoeducationperception of birth

Outcome Measures

Primary Outcomes (1)

  • Traumatic Birth Perception Scale (TBPS)

    The TBPS was developed in 2016 by Yalnız et al. to determine the level of perception of labor as trauma. The TPAS is used to determine the perceptions of birth among women aged 15-49, receiving preconception counseling, and attending delivery rooms, obstetrics, or postpartum services during pregnancy. The TPAS has a total of 13 items. Each item is rated from 0 (zero) to 10 (ten). The lowest score on the TPAS is 0 (zero), and the highest is 130. As the score on the scale increases, the extent to which women perceive birth as trauma increases. Women who score "0-26" on the scale have a very low perception of birth as traumatic, those who score "27-52" have a low perception, those who score "53-78" have a moderate perception, those who score "79-109" have a high perception, and those who score "105-130" have a very high perception of birth as traumatic. The Cronbach alpha coefficient of the original form of the scale is 0.895.

    4 months

Secondary Outcomes (3)

  • Mother-to-Infant Bonding Scale (MIBS)

    4 months

  • Breastfeeding Self-Efficacy Scale Short Form (BSES-SF)

    4 months

  • Edinburgh Postnatal Depression Scale (EPDS)

    4 months

Study Arms (2)

Psychoeducation

EXPERIMENTAL

Pregnant women with a traumatic perception of birth who received psychoeducational intervention formed the experimental group.

Behavioral: psychoeducation

Control

NO INTERVENTION

Pregnant women with a traumatic birth perception who did not receive psychoeducation intervention and underwent routine prenatal follow-up constituted the control group.

Interventions

psychoeducationBEHAVIORAL

The nurse/midwife-led psychoeducation intervention aims to encourage pregnant women to express their feelings about childbirth. It also provides a counseling framework to help women identify and overcome the distressing elements of childbirth. Psychoeducation allows pregnant women to obtain complete, evidence-based information about labor and to discuss their feelings and thoughts about the method of delivery and birth. Providing evidence-based information by nurses/midwives during psychoeducation helps pregnant women make informed decisions about their birth preferences. In addition to evidence-based information, the psychoeducation intervention includes discussing myths and misconceptions, increasing social support, reinforcing positive coping strategies, and focusing on problem solutions. Nurses/midwives encourage pregnant women to develop a positive birth plan through psychoeducation.

Psychoeducation

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailspregnant women
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Primigravida
  • Between 22 and 32 weeks gestation
  • Experiencing a healthy pregnancy
  • Spontaneously pregnant
  • No psychiatric illness
  • Scored 79 or higher on the Traumatic Birth Perception Scale were included in the study.

You may not qualify if:

  • High-risk pregnant women
  • Without a smartphone, tablet, computer or internet access

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Umraniye Education and Research Hospital

Istanbul, Umraniye, Turkey (Türkiye)

Location

Related Publications (14)

  • Pandey Bista A, Shrama C, Shrestha U, Timalsina P, Devkota K, Piya K, Neupane B. Effect of Group Psycho-Educational Interventions on Child birth fear and Child birth Self-efficacy among Primiparous women. J Nepal Health Res Counc. 2023 Jul 20;20(4):846-851. doi: 10.33314/jnhrc.v20i4.4028.

    PMID: 37489666BACKGROUND
  • 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.

  • Akgun M, Boz I, Ozer Z. The effect of psychoeducation on fear of childbirth and birth type: systematic review and meta-analysis. J Psychosom Obstet Gynaecol. 2020 Dec;41(4):253-265. doi: 10.1080/0167482X.2019.1689950. Epub 2019 Nov 13.

  • Boz I, Akgun M, Duman F. A feasibility study of a psychoeducation intervention based on Human Caring Theory in nulliparous women with fear of childbirth. J Psychosom Obstet Gynaecol. 2021 Dec;42(4):300-312. doi: 10.1080/0167482X.2020.1752173. Epub 2020 Apr 22.

  • Gultekin, N. (2018). Does Psychoeducation Encourage Pregnant Women and Positively Influence the Relation between Mother and Baby: a Case-Control Study. Int J Gynecol Clin Pract, 5(143), 2

    RESULT
  • Jiao N, Zhu L, Chong YS, Chan WS, Luo N, Wang W, Hu R, Chan YH, He HG. Web-based versus home-based postnatal psychoeducational interventions for first-time mothers: A randomised controlled trial. Int J Nurs Stud. 2019 Nov;99:103385. doi: 10.1016/j.ijnurstu.2019.07.002. Epub 2019 Jul 21.

  • Kordi, M., Bakhshi, M., Masoudi, S., & Esmaily, H. (2017). Effect of a childbirth psychoeducation program on the level of fear of childbirth in primigravid women. Evidence Based Care, 7(3), 26-34.

    RESULT
  • Lawrence CG, Breau G, Yang L, Hellerstein OS, Hippman C, Kennedy AL, Ryan D, Shulman B, Brotto LA. Effectiveness of a web-enabled psychoeducational resource for postpartum depression and anxiety among women in British Columbia. Arch Womens Ment Health. 2024 Dec;27(6):995-1010. doi: 10.1007/s00737-024-01468-8. Epub 2024 May 6.

  • Maharani Dewi, U., Windarti, Y., & Hayani, H. (2023). The Effect of Lactation Psychoeducation Using a Video-Based Comprehensive Model on the Level of Anxiety of Mothers in Breastfeeding. Health Education and Health Promotion, 11(3), 1001-1013.

    RESULT
  • Hollander MH, van Hastenberg E, van Dillen J, van Pampus MG, de Miranda E, Stramrood CAI. Preventing traumatic childbirth experiences: 2192 women's perceptions and views. Arch Womens Ment Health. 2017 Aug;20(4):515-523. doi: 10.1007/s00737-017-0729-6. Epub 2017 May 29.

  • Firouzan L, Kharaghani R, Zenoozian S, Moloodi R, Jafari E. The effect of midwifery led counseling based on Gamble's approach on childbirth fear and self-efficacy in nulligravida women. BMC Pregnancy Childbirth. 2020 Sep 9;20(1):522. doi: 10.1186/s12884-020-03230-1.

  • Fenwick J, Toohill J, Slavin V, Creedy DK, Gamble J. Improving psychoeducation for women fearful of childbirth: Evaluation of a research translation project. Women Birth. 2018 Feb;31(1):1-9. doi: 10.1016/j.wombi.2017.06.004. Epub 2017 Jul 3.

  • Kuipers YJ, Thomson G, Goberna-Tricas J, Zurera A, Hresanova E, Temesgenova N, Waldner I, Leinweber J. The social conception of space of birth narrated by women with negative and traumatic birth experiences. Women Birth. 2023 Feb;36(1):e78-e85. doi: 10.1016/j.wombi.2022.04.013. Epub 2022 May 2.

  • Nagle U, Naughton S, Ayers S, Cooley S, Duffy RM, Dikmen-Yildiz P. A survey of perceived traumatic birth experiences in an Irish maternity sample - prevalence, risk factors and follow up. Midwifery. 2022 Oct;113:103419. doi: 10.1016/j.midw.2022.103419. Epub 2022 Jul 9.

MeSH Terms

Conditions

Birth Injuries

Condition Hierarchy (Ancestors)

Infant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesWounds and Injuries

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: psychoeducation and control
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

August 14, 2025

First Posted

September 24, 2025

Study Start

April 6, 2023

Primary Completion

April 26, 2024

Study Completion

October 7, 2024

Last Updated

September 24, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

because there is no release yet

Locations