NCT05680272

Brief Summary

it was aimed to determine the effect of empathic communication-based education on positive birth perception awareness.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2023

Typical duration for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 29, 2022

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 11, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

February 15, 2023

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 19, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 19, 2024

Completed
Last Updated

January 28, 2025

Status Verified

January 1, 2025

Enrollment Period

1.8 years

First QC Date

December 29, 2022

Last Update Submit

January 25, 2025

Conditions

Keywords

PregnancyScaleEmpathic CommunicationPositive Perception of BirthMidwifery Care

Outcome Measures

Primary Outcomes (1)

  • Positive Birth Perception Awareness Scale

    Positive Birth Perception Awareness Scale (PDAFS): Focus group interviews will be held with 10-12 pregnant women for the scale to be developed. An item pool will be created from the themes and sub-areas obtained from the interviews. In addition, the factors affecting the awareness of positive birth perception of pregnant women were examined by examining the national and international literature, and a form will be prepared for the pilot study. The scale form, the literature study of the researchers and the findings of the focus group interviews will be re-evaluated and the pilot study form of the scale will be prepared. The pilot study form will be submitted to the expert opinion. The pilot form will be sent to 10-12 experts. By making arrangements in line with expert opinions, the question pool will be finalized before the application, and it will be transformed into a 5-point Likert scale model

    baseline

Secondary Outcomes (1)

  • Wijma Birth Experience/Expectation Scale A (WBBSS-A)

    baseline

Study Arms (2)

extrimental group

EXPERIMENTAL

The experimental group will be given training on empathetic communication and the positive birth perception awareness scale will be applied to the experimental group.

Behavioral: empathic communication-based education

control group

NO INTERVENTION

No intervention will be made in the control group.

Interventions

The study will consist of two stages. The first stage will be methodological in order to develop the Positive Birth Perception Awareness Scale based on Empathic Communication, and the second stage will be a trial model with a pretest-posttest control group in order to determine the effect of the training given to pregnant women based on empathic communication on positive birth perception awareness and birth experience.

extrimental group

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • years and older pregnancy
  • Speaks and understands Turkish
  • Able to read and write,
  • Having a single fetus,
  • Not having a risky pregnancy,
  • in gestational week,
  • Pregnant women who do not have any disability diagnosed for normal delivery

You may not qualify if:

  • Risky pregnant women
  • Pregnant women with communication difficulties
  • Pregnant women with mental deficiency

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kahramanmaraş Sütçü İmam Universty

Kahramanmaraş, 46040, Turkey (Türkiye)

Location

Related Publications (21)

  • Karacam Z, Akyüz EÖ. Supportive care given in labor and the role of the midwife/nurse. FNJN 2011;19(1):45-5.

    RESULT
  • Fullerton JT, Thompson JB, Severino R; International Confederation of Midwives. The International Confederation of Midwives essential competencies for basic midwifery practice. an update study: 2009-2010. Midwifery. 2011 Aug;27(4):399-408. doi: 10.1016/j.midw.2011.03.005. Epub 2011 May 20.

  • . Şenoğlu, A., & Karaçam, Z. Opinions and Needs of Birth Supporters on Participation in Birth. Dokuz Eylül University Faculty of Nursing Electronic Journal, 2019;12(4), 274-282.

    RESULT
  • Lazzaretto E, Nespoli A, Fumagalli S, Colciago E, Perego S, Locatelli A. Intrapartum care quality indicators: a literature review. Minerva Ginecol. 2018 Jun;70(3):346-356. doi: 10.23736/S0026-4784.17.04177-6. Epub 2017 Nov 21.

  • Haapio S, Kaunonen M, Arffman M, Astedt-Kurki P. Effects of extended childbirth education by midwives on the childbirth fear of first-time mothers: an RCT. Scand J Caring Sci. 2017 Jun;31(2):293-301. doi: 10.1111/scs.12346. Epub 2016 Jul 21.

  • Toohill J, Callander E, Gamble J, Creedy DK, Fenwick J. A cost effectiveness analysis of midwife psycho-education for fearful pregnant women - a health system perspective for the antenatal period. BMC Pregnancy Childbirth. 2017 Jul 11;17(1):217. doi: 10.1186/s12884-017-1404-7.

  • Rouhe H, Salmela-Aro K, Toivanen R, Tokola M, Halmesmaki E, Ryding EL, Saisto T. Group psychoeducation with relaxation for severe fear of childbirth improves maternal adjustment and childbirth experience--a randomised controlled trial. J Psychosom Obstet Gynaecol. 2015;36(1):1-9. doi: 10.3109/0167482X.2014.980722. Epub 2014 Nov 24.

  • Lea J, Cruickshank M. Supporting new graduate nurses making the transition to rural nursing practice: views from experienced rural nurses. J Clin Nurs. 2015 Oct;24(19-20):2826-34. doi: 10.1111/jocn.12890. Epub 2015 Jul 14.

  • Oladapo OT, Tuncalp O, Bonet M, Lawrie TA, Portela A, Downe S, Gulmezoglu AM. WHO model of intrapartum care for a positive childbirth experience: transforming care of women and babies for improved health and wellbeing. BJOG. 2018 Jul;125(8):918-922. doi: 10.1111/1471-0528.15237. Epub 2018 May 15. No abstract available.

  • Ryding EL, Lukasse M, Parys AS, Wangel AM, Karro H, Kristjansdottir H, Schroll AM, Schei B; Bidens Group. Fear of childbirth and risk of cesarean delivery: a cohort study in six European countries. Birth. 2015 Mar;42(1):48-55. doi: 10.1111/birt.12147.

  • Navaee M, Abedian Z. Effect of role play education on primiparous women's fear of natural delivery and their decision on the mode of delivery. Iran J Nurs Midwifery Res. 2015 Jan-Feb;20(1):40-6.

  • Rouhe H, Salmela-Aro K, Toivanen R, Tokola M, Halmesmaki E, Saisto T. Obstetric outcome after intervention for severe fear of childbirth in nulliparous women - randomised trial. BJOG. 2013 Jan;120(1):75-84. doi: 10.1111/1471-0528.12011. Epub 2012 Nov 2.

  • Aktas S, Pasinlioglu T. The effect of empathy training given to midwives on the empathic communication skills of midwives and the birth satisfaction of mothers giving birth with the help of these midwives: A quasi-experimental study. J Eval Clin Pract. 2021 Aug;27(4):858-867. doi: 10.1111/jep.13523. Epub 2020 Dec 6.

  • Buchanan L, Anderson E, MBiostat HX, Phongsavan P, Rissel C, Wen LM. Sources of information and the use of mobile applications for health and parenting information during pregnancy: Implications for health promotion. Health Informatics J. 2021 Jul-Sep;27(3):14604582211043146. doi: 10.1177/14604582211043146.

  • Bogale B, Morkrid K, Abbas E, Abu Ward I, Anaya F, Ghanem B, Hijaz T, Isbeih M, Issawi S, A S Nazzal Z, E Qaddomi S, Froen JF. The effect of a digital targeted client communication intervention on pregnant women's worries and satisfaction with antenatal care in Palestine-A cluster randomized controlled trial. PLoS One. 2021 Apr 23;16(4):e0249713. doi: 10.1371/journal.pone.0249713. eCollection 2021.

  • Biaggi A, Conroy S, Pawlby S, Pariante CM. Identifying the women at risk of antenatal anxiety and depression: A systematic review. J Affect Disord. 2016 Feb;191:62-77. doi: 10.1016/j.jad.2015.11.014. Epub 2015 Nov 18.

  • Wijma K, Wijma B, Zar M. Psychometric aspects of the W-DEQ; a new questionnaire for the measurement of fear of childbirth. J Psychosom Obstet Gynaecol. 1998 Jun;19(2):84-97. doi: 10.3109/01674829809048501.

  • Faul F, Erdfelder E, Lang AG, Buchner A. G*Power 3: a flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behav Res Methods. 2007 May;39(2):175-91. doi: 10.3758/bf03193146.

  • Dökmen Ü. Communication conflicts and empathy. 48th edition. Istanbul: Remzi Bookstore,2012.

    RESULT
  • Gaskin IM. Ina May's Birth Preparation Guide. Erkök EE, Guler ZB (Transl). 1st edition. Istanbul: Sinek Eight Publishing House,2015.

    RESULT
  • Cevik A, Alan S. Mental Health and Diseases for Midwives. Ed. Alan S. Pregnancy and Postpartum Period. Ankara; Academician Bookstore, 2019.

    RESULT

Study Officials

  • Sultan ALAN

    Çukuroava Universty

    PRINCIPAL INVESTIGATOR
  • Emine AKSÜT AKÇAY

    Kahramanmaraş Sütçü İmam Universty

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
In the first stage of the research, it is planned to take a sample of at least 5-10 times the number of items of the scale planned to be developed. The sample size should be at least 200 to reveal the psychometric structure of the scale adequately, 300 and ideally over 500 to reveal the factor structure. In the second phase, it is aimed to reach at least 72 people, 36 in the intervention group and 36 in the control group.
Purpose
SUPPORTIVE CARE
Intervention Model
SEQUENTIAL
Model Details: education-centered randomized controlled experimental study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

December 29, 2022

First Posted

January 11, 2023

Study Start

February 15, 2023

Primary Completion

December 19, 2024

Study Completion

December 19, 2024

Last Updated

January 28, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

I do not approve of sharing ipd

Locations