Individual Training Given to Pregnant Women in the Earthquake Zone in Their Living Spaces,

NCT06110819 | Unknown

• 1 other identifier: TurkishHKahramanmara
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to evaluate the effect of individual training and pregnancy follow-up given to pregnant women in the earthquake zone in their living spaces on prenatal comfort, distress, risk perception and birth anxiety. In the randomized controlled experimental study, data will be obtained using the Personal Information Form, Pregnant Observations and Birth Results, Prenatal Comfort Scale, Prenatal Distress Scale, Pregnancy Risk Perception Scale, Oxford Birth Anxiety Scale.

Conditions

Pregnant Women

Outcome Measures

Primary Outcomes (4)

• Prenatal Comfort Scale

  The scale is evaluated out of a total of 75 points. It is interpreted that as the score decreases, the comfort level also decreases, and as the score increases, the comfort level also increases. The scale has no reverse-scored items and no cut-off points.

  hrough study completion, an average of 1 week

• Prenatal Distress Scale

  The total score of the items is taken as a value between 0-34. Yuksel et al. The cut-off value of the scale has not been calculated and a high score from the scale indicates a high level of prenatal distress.

  15 minutes before the training, 15 minutes after the training is completed

• Pregnancy Risk Perception Scale

  Each item in the scale has a linear line of 0-10 cm (0-100 mm), and at the two ends of these lines are the expressions "no risk" and "extremely high risk". The total score of the scale is obtained by summing the scores of the nine items and dividing the resulting score by 9. A scoring can also be made for the factors of the scale: Similar to the total score calculation, it is calculated by dividing the sum of the scores from the relevant sub-dimensions of the scale by the number of items in that sub-dimension. The scale has no cut-off point. An increase in the score obtained from the scale indicates that the risk perception of the pregnant woman for herself and her baby increases.

  15 minutes before the training, 15 minutes after the training is completed

• Oxford Birth Anxiety Scale:

  Women's concerns about the birth process were evaluated with a four-point Likert scale. Scale; It can be applied to women in all periods before, during and after birth; It was scored as "1: I was very worried", "2: I was quite worried", "3: I was not very worried", "4: I was not worried at all". The scale is evaluated based on the total score (min = 10, max = 40). It is interpreted that as the score increases, women's anxiety level decreases. The scale, which has three subscales: "pain and distress", "prenatal uncertainty" and "interventions", does not have reverse questions.

  15 minutes before the training, 15 minutes after the training is completed

Study Arms (2)

Workgroup

EXPERIMENTAL

.In line with the Prenatal Care Management Guide of the Ministry of Health, each pregnant woman will be trained and monitored during their trimester until they give birth (4 follow-ups). Pregnancy training trimesters of all participants will be given in accordance with the health guide and follow-up will be done in their living spaces. During these trainings, they will be provided with care in line with the recommendations of the Ministry of Health.

Other: Workgroup

Control

OTHER

Pregnant women will be contacted by phone and the status of their follow-up in health institutions will be questioned. During these follow-ups, training is provided and monitoring is carried out in line with the Prenatal Care Management Guide of the Ministry of Health.

Other: control

Interventions

control OTHER

Pregnant women will be contacted by phone and the status of their follow-up in health institutions will be questioned. During these follow-ups, training is provided and monitoring is carried out in line with the Prenatal Care Management Guide of the Ministry of Health.

Control

Workgroup OTHER

Experimental: .In line with the Prenatal Care Management Guide of the Ministry of Health, each pregnant woman will be trained and monitored during their trimester until they give birth (4 follow-ups). Pregnancy training trimesters of all participants will be given in accordance with the health guide and follow-up will be done in their living spaces. During these trainings, they will be provided with care in line with the recommendations of the Ministry of Health.

Workgroup

Eligibility Criteria

• Age: 18 Years - 35 Years
• Gender Eligibility Details: pregnant
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Ability to speak Turkish,
• First pregnancy
• Agreeing to participate in the study
• weeks pregnant

You may not qualify if:

• Pregnant women who do not continue the program.
• Attending a pregnancy education class

Sponsors & Collaborators

• Turkish Ministry of Health, Kahramanmaras Provincial Health Directorate: lead

Study Sites (1)

TurkishMoHKahramanmarasPH

Kahramanmaraş, 46050, Turkey (Türkiye)

RECRUITING

Related Publications (21)

• Amarpoor Mesrkanlou H, Ghaemmaghami Hezaveh SJ, Tahmasebi S, Nikniaz Z, Nikniaz L. The Effect of an Earthquake Experienced During Pregnancy on Maternal Health and Birth Outcomes. Disaster Med Public Health Prep. 2022 Jun 27;17:e157. doi: 10.1017/dmp.2022.132.

  PMID: 35757895 BACKGROUND

• Cankaya S, Simsek B. Effects of Antenatal Education on Fear of Birth, Depression, Anxiety, Childbirth Self-Efficacy, and Mode of Delivery in Primiparous Pregnant Women: A Prospective Randomized Controlled Study. Clin Nurs Res. 2021 Jul;30(6):818-829. doi: 10.1177/1054773820916984. Epub 2020 Apr 13.

  PMID: 32281410 BACKGROUND

• Dennis CL, Dowswell T. Psychosocial and psychological interventions for preventing postpartum depression. Cochrane Database Syst Rev. 2013 Feb 28;2013(2):CD001134. doi: 10.1002/14651858.CD001134.pub3.

  PMID: 23450532 BACKGROUND

• Uludag E, Sercekus P, Vardar O, Ozkan S, Alatas SE. Effects of online antenatal education on worries about labour, fear of childbirth, preparedness for labour and fear of covid-19 during the covid-19 pandemic: A single-blind randomised controlled study. Midwifery. 2022 Dec;115:103484. doi: 10.1016/j.midw.2022.103484. Epub 2022 Sep 9.

  PMID: 36155390 BACKGROUND

• Fernandez Turienzo C, Bick D, Briley AL, Bollard M, Coxon K, Cross P, Silverio SA, Singh C, Seed PT, Tribe RM, Shennan AH, Sandall J; POPPIE Pilot Collaborative Group. Midwifery continuity of care versus standard maternity care for women at increased risk of preterm birth: A hybrid implementation-effectiveness, randomised controlled pilot trial in the UK. PLoS Med. 2020 Oct 6;17(10):e1003350. doi: 10.1371/journal.pmed.1003350. eCollection 2020 Oct.

  PMID: 33022010 BACKGROUND

• Gooijers J, Swinnen SP. Interactions between brain structure and behavior: the corpus callosum and bimanual coordination. Neurosci Biobehav Rev. 2014 Jun;43:1-19. doi: 10.1016/j.neubiorev.2014.03.008. Epub 2014 Mar 21.

  PMID: 24661987 BACKGROUND

• Hawkins G, Gullam J, Belluscio L. The effect of a major earthquake experienced during the first trimester of pregnancy on the risk of preterm birth. Aust N Z J Obstet Gynaecol. 2019 Feb;59(1):82-88. doi: 10.1111/ajo.12797. Epub 2018 Mar 8.

  PMID: 29516471 BACKGROUND

• Ketema DB, Leshargie CT, Kibret GD, Assemie MA, Petrucka P, Alebel A. Effects of maternal education on birth preparedness and complication readiness among Ethiopian pregnant women: a systematic review and meta-analysis. BMC Pregnancy Childbirth. 2020 Mar 6;20(1):149. doi: 10.1186/s12884-020-2812-7.

  PMID: 32143581 BACKGROUND

• Kyozuka H, Murata T, Yasuda S, Ishii K, Fujimori K, Goto A, Yasumura S, Ota M, Hata K, Suzuki K, Nakai A, Ohira T, Ohto H, Kamiya K. The Effects of the Great East Japan Earthquake on Perinatal Outcomes: Results of the Pregnancy and Birth Survey in the Fukushima Health Management Survey. J Epidemiol. 2022;32(Suppl_XII):S57-S63. doi: 10.2188/jea.JE20210444.

  PMID: 36464301 BACKGROUND

• Lian Q, Ni J, Zhang J, Little J, Luo S, Zhang L. Maternal exposure to Wenchuan earthquake and prolonged risk of offspring birth outcomes: a natural experiment study. BMC Pregnancy Childbirth. 2020 Sep 22;20(1):552. doi: 10.1186/s12884-020-03206-1.

  PMID: 32962638 BACKGROUND

• Matvienko-Sikar K, Dockray S. Effects of a novel positive psychological intervention on prenatal stress and well-being: A pilot randomised controlled trial. Women Birth. 2017 Apr;30(2):e111-e118. doi: 10.1016/j.wombi.2016.10.003. Epub 2016 Oct 31.

  PMID: 27810284 BACKGROUND

• Adal MN. The fine structure of the sensory region of cat muscle spindles. J Ultrastruct Res. 1969 Feb;26(3):332-53. doi: 10.1016/s0022-5320(69)80011-0. No abstract available.

  PMID: 4237927 BACKGROUND

• O'Hara MW, Wisner KL. Perinatal mental illness: definition, description and aetiology. Best Pract Res Clin Obstet Gynaecol. 2014 Jan;28(1):3-12. doi: 10.1016/j.bpobgyn.2013.09.002. Epub 2013 Oct 7.

  PMID: 24140480 BACKGROUND

• Palmeiro-Silva YK, Orellana P, Venegas P, Monteiro L, Varas-Godoy M, Norwitz E, Rice G, Osorio E, Illanes SE. Effects of earthquake on perinatal outcomes: A Chilean register-based study. PLoS One. 2018 Feb 23;13(2):e0191340. doi: 10.1371/journal.pone.0191340. eCollection 2018.

  PMID: 29474413 BACKGROUND

• Silbereisen RK, Oesterreich R, Leitner K. [Configurations of attitudes, experiences and expectations of social welfare recipients]. Z Klin Psychol Psychother. 1977;25(3):256-63. German.

  PMID: 595769 BACKGROUND

• Swift EM, Zoega H, Stoll K, Avery M, Gottfreethsdottir H. Enhanced Antenatal Care: Combining one-to-one and group Antenatal Care models to increase childbirth education and address childbirth fear. Women Birth. 2021 Jul;34(4):381-388. doi: 10.1016/j.wombi.2020.06.008. Epub 2020 Jul 24.

  PMID: 32718800 BACKGROUND

• LeDoux JE, Wilson DH, Gazzaniga MS. A divided mind: observations on the conscious properties of the separated hemispheres. Ann Neurol. 1977 Nov;2(5):417-21. doi: 10.1002/ana.410020513.

  PMID: 103484 BACKGROUND

• Watanabe Z, Iwama N, Nishigori H, Nishigori T, Mizuno S, Sakurai K, Ishikuro M, Obara T, Tatsuta N, Nishijima I, Fujiwara I, Nakai K, Arima T, Takeda T, Sugawara J, Kuriyama S, Metoki H, Yaegashi N; Japan Environment & Children's Study Group. Psychological distress during pregnancy in Miyagi after the Great East Japan Earthquake: The Japan Environment and Children's Study. J Affect Disord. 2016 Jan 15;190:341-348. doi: 10.1016/j.jad.2015.10.024. Epub 2015 Oct 28.

  PMID: 26544618 BACKGROUND

• Yamashita K, Natsukawa T, Kubo T, Kondo H, Koido Y. Vulnerability of Pregnant Women After a Disaster: Experiences After the Kumamoto Earthquake in Japan. Prehosp Disaster Med. 2019 Oct;34(5):569-571. doi: 10.1017/S1049023X1900476X. Epub 2019 Aug 30. No abstract available.

  PMID: 31466549 BACKGROUND

• Yuksel F, Akin S, Durna Z. Prenatal distress in Turkish pregnant women and factors associated with maternal prenatal distress. J Clin Nurs. 2014 Jan;23(1-2):54-64. doi: 10.1111/j.1365-2702.2012.04283.x. Epub 2013 Jan 11.

  PMID: 23305376 BACKGROUND

• Senol DK, Keles MG. The effect of individual education and care provided in living spaces to pregnant women in the earthquake region on prenatal distress, risk perception, and labour anxiety. BMC Pregnancy Childbirth. 2025 Feb 3;25(1):109. doi: 10.1186/s12884-025-07233-8.

  PMID: 39901147 DERIVED

Central Study Contacts

mine gökduman keleş, Midwifery

CONTACT

05055624560; minegokdumankeles@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Analyzes will not be made by the researcher.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: DR.Midwifery

Model Details: In line with the Prenatal Care Management Guide of the Ministry of Health, each pregnant woman will be trained and monitored during their trimester until they give birth (4 follow-ups). Pregnancy training trimesters of all participants will be given in accordance with the health guide and follow-up will be done in their living spaces. During these trainings, they will be provided with care in line with the recommendations of the Ministry of Health.

Study Record Dates

• First Submitted: October 20, 2023
• First Posted: November 1, 2023
• Study Start: February 9, 2023
• Primary Completion: December 9, 2023
• Study Completion: December 30, 2023
• Last Updated: November 1, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will share

Locations

TU (1)