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Pregnancy RelatedNCT05680272

Women's Positive Birth Perception Awareness and Birth Experience

A study testing empathic communication-based education in people with Pregnancy Related, run by Kahramanmaras Sutcu Imam University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

it was aimed to determine the effect of empathic communication-based education on positive birth perception awareness. Read more about this study

Who is it for?
Ages 18 to 40 years, women onlyHealthy volunteers can take part
Conditions the study is for
Pregnancy Related
What is being tested?
empathic communication-based education
Could I receive a placebo?
No, everyone receives an active treatment
How many people
72 participants
Where
1 siteTurkey (Türkiye)
Study dates
15 Feb 2023to 19 Dec 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 40 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 18 years and older pregnancy
  • Speaks and understands Turkish
  • Able to read and write,
  • Having a single fetus,
  • Not having a risky pregnancy,
  • 32-36. in gestational week,
  • Pregnant women who do not have any disability diagnosed for normal delivery

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • Kahramanmaraş Sütçü İmam Universty

    Kahramanmaraş, 46040

Other trials in Turkey (Türkiye)

About this study

Official title: The Effect of Empathic Communication-Based Education on Women's Positive Birth Perception Awareness and Birth Experience

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

Read the detailed description

Since the existence of humanity, women have not been left alone during pregnancy, childbirth and postpartum period in all societies, but have been supported by their environment. In providing this support, midwives have important responsibilities as the primary responsible health professional . Quality midwifery care given at birth is very important for women to have a positive birth experience The biggest expectations of mothers from midwives in the birth and postpartum period are; it is approaching with empathetic communication such as smiling, therapeutic touch, listening, speaking in a language that the pregnant can understand, making oneself feel good, encouraging, informing, paying attention to privacy. Mothers whose expectations are met in labor; It can have positive obstetric outcomes such as shortening the delivery time, reduction in analgesia and medical intervention applications, positive birth experience, initiation of breastfeeding in the early period, mother-infant bonding and transition to the role of motherhood .

İt will contribute positively to the health indicators of the country and reduce the cost, a scale and guide have been prepared within the scope of this thesis, with the foresight that pregnant women and health workers need training materials, and training with interactive and mobile communication tools in this direction. has been planned.It is expected that the training to be given in line with the developed guideline, and the empathic communication-based training given in the third trimester of pregnancy will help to increase the awareness of women's positive perception of birth.

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

Being tested
empathic communication-based education
Keywords
Pregnancy, Scale, Empathic Communication, Positive Perception of Birth, Midwifery Care

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • empathic communication-based educationBehavioural

    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.

Study groups in NCT05680272
Study groupRoleWhat they receive
extrimental groupExperimentalThe experimental group will be given training on empathetic communication and the positive birth perception awareness scale will be applied to the experimental group.
Receives: Behavioral: empathic communication-based education
control groupNo interventionNo intervention will be made in the control group.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: baseline

Secondary outcomes (1)

  1. Wijma Birth Experience/Expectation Scale A (WBBSS-A)

    The scale consists of 33 items. The answers in the scale are in six-point Likert type numbered from 0 to 5. 0 is evaluated as "totally" and 5 as "not at all". The lowest score obtained from the scale is 0 and the highest score is 165. These; Those who have low level of fear of childbirth (WBLSS score ≤ 37), those who have moderate fear of childbirth (WBBSS-A score between 38-65).

    Measured: baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jan 2023
  2. Study start15 Feb 2023
  3. Primary completion19 Dec 2024
  4. Study completion19 Dec 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Sequential
Model description
education-centered randomized controlled experimental study
Masking
None (open label)
Enrolment
72 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05680272
Sponsor's protocol ID
TRKMARAŞ46
Status last verified
Jan 2025
First submitted
29 Dec 2022
Last updated
28 Jan 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: I do not approve of sharing ipd

Publications

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

  • International Confederation of Midwives. Essential competencies for basic midwifery Practice 2018.URL:https://internationalmidwives.org/assets/uploads/documents/CoreDocuments/ENG%20Definition_of_the_Midwife%202017.p df. 20 Nisan 2018.

  • . 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.

  • 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.

    PubMed 29161798

  • 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.

    PubMed 27439382

  • 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.

    PubMed 28693447

  • 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.

    PubMed 25417935

  • 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.

    PubMed 26177875

  • 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.

    PubMed 29637727

  • 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.

    PubMed 25676793

  • 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.

    PubMed 25709689

  • 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.

    PubMed 23121002

  • 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.

    PubMed 33283424

  • 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.

    PubMed 34569327

  • 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.

    PubMed 33891597

Questions about this trial

What is this clinical trial studying?

A study testing empathic communication-based education in people with Pregnancy Related, run by Kahramanmaras Sutcu Imam University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Positive Birth Perception Awareness Scale (time frame: baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05680272, which also lists 21 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2025.

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