- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05680272
Women's Positive Birth Perception Awareness and Birth Experience
The Effect of Empathic Communication-Based Education on Women's Positive Birth Perception Awareness and Birth Experience
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Kahramanmaraş, Turkey, 46040
- Kahramanmaraş Sütçü İmam Universty
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
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
Exclusion Criteria:
- Risky pregnant women
- Pregnant women with communication difficulties
- Pregnant women with mental deficiency
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: extrimental group
The experimental group will be given training on empathetic communication and the positive birth perception awareness scale will be applied to the experimental group.
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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.
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No Intervention: control group
No intervention will be made in the control group.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Positive Birth Perception Awareness Scale
Time Frame: baseline
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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
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baseline
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Wijma Birth Experience/Expectation Scale A (WBBSS-A)
Time Frame: baseline
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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).
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baseline
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Collaborators and Investigators
Investigators
- Principal Investigator: Sultan ALAN, Çukuroava Universty
- Principal Investigator: Emine AKSÜT AKÇAY, Kahramanmaraş Sütçü İmam Universty
Publications and helpful links
General Publications
- 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.
- Karacam Z, Akyüz EÖ. Supportive care given in labor and the role of the midwife/nurse. FNJN 2011;19(1):45-5.
- . 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.
- 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.
- Dökmen Ü. Communication conflicts and empathy. 48th edition. Istanbul: Remzi Bookstore,2012.
- Gaskin IM. Ina May's Birth Preparation Guide. Erkök EE, Guler ZB (Transl). 1st edition. Istanbul: Sinek Eight Publishing House,2015.
- Cevik A, Alan S. Mental Health and Diseases for Midwives. Ed. Alan S. Pregnancy and Postpartum Period. Ankara; Academician Bookstore, 2019.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- TRKMARAŞ46
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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