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

Pregnant Women Clinical Trial

Official title:

Individual Training Given to Pregnant Women in the Earthquake Zone in Their Living Spaces, the Effect of Pregnancy Follow-up on Prenatal Comfort, Distress, Risk Perception and Birth Anxiety.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06110819
• Other study ID #: TurkishHKahramanmara
• Status: Recruiting
• Phase: N/A
• Start date: February 9, 2023
• Est. completion date: December 30, 2023

Study information

• Verified date: October 2023
• Source: Turkish Ministry of Health, Kahramanmaras Provincial Health Directorate
• Contact: mine gökduman keles, Midwifery
• Phone: 05055624560
• Email: minegokdumankeles[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

In the literature, it has been reported that the earthquake had a negative impact on pregnant women, as well as material and loss of life (Amarpoor Mesrkanlou, et al. 2023; Kyozuka, et al. 2022; Nishigori, et al. 2014; Watanabe, et al. al. 2016). In the study of İlavaten Mesrkanlou et al (2023); It has also been reported that post-earthquake causes insufficient weight gain in pregnant women, decreased hemoglobin levels, and adverse birth outcomes. (Amarpoor Mesrkanlou, et al. 2023). Again, in the research of Kyozuko et al., (2022); It has been reported that pregnancy complications such as gestational hypertension, respiratory diseases and mental disorders increased in pregnant women after the earthquake (Kyozuka, et al. 2022). In their study, Mesrkanlou et al., (2023) reported postpartum depression as 21.3% in 633 pregnant women in the regions affected by the East Japan earthquake (Nishigori, et al. 2014). Watanabe, et al. (2016) reported psychological distress among pregnant women in the Miyagi region of Japan as 4.9% in their study (Watanabe, et al. 2016). In addition, the earthquake may result in negative effects during pregnancy, such as premature birth, low birth weight and hypertensive disorders. (Hawkins, et al. 2019; Lian, et al. 2020; Palmeiro-Silva, et al. 2018). As a result of the 6.3 magnitude earthquake in Christchurch, New Zealand, premature birth was reported as 6.71% in 1057 pregnant women (Hawkins, et al. 2019). In addition, in the study that examined the relationships between earthquake exposure of pregnant women and negative birth outcomes and included 73,493 women, pregnant women exposed to the earthquake had a 2% higher rate of stillbirth and 14.14% higher preterm birth compared to pregnant women not exposed to the earthquake (Lian, et al. 2020). ).

In this context, increased levels of anxiety and depression during pregnancy may affect the comfort level of the pregnant woman (Matvienko-Sikar and Dockray 2017). In addition, prenatal stress is defined as the emotional reactions of the pregnant woman in terms of physical, psychological and social changes that occur during pregnancy, birth, parenthood and baby health (O'Hara and Wisner 2014). Again, inadequate prenatal care increases perinetal stress (Gooijers and Swinnen 2014). In a study conducted in Turkey, it was reported that perinetal stress affected preterm birth the most during pregnancy (Yuksel, et al. 2014). Pregnant women are among the most vulnerable people who may need special support in the event of an earthquake. Therefore, pregnant women should be provided with stronger support after the earthquake.

For this reason, it is important to provide and maintain the care of pregnant women face to face by health professionals after the earthquake (Yamashita, et al. 2019). In addition, the education given to pregnant women is also effective in preventing premature birth and postpartum depression (Çankaya and Şimşek 2021; Dennis and Dowswell 2013). In addition, it has been reported in the literature that the satisfaction of pregnant women is increased with the different education models (home visits, medical care, individualized care) provided during pregnancy. (MOUNTAINS, et al. 2015; Fernandez Turienzo, et al. 2020; Shen, et al. 2022; Swift, et al. 2021). In a meta-analysis study, education during pregnancy reported that women were prepared for pregnancy complications (Ketema, et al. 2020). Lack of information and fear of the unknown during pregnancy and birth increase the stress of pregnant women (Uludağ, et al. 2022).

These results emphasize the need for follow-up and education of pregnant women in order to reduce the negative effects on pregnant women after the earthquake. It is thought that individual training and pregnancy follow-up given to pregnant women in the earthquake zone in their living spaces will increase prenatal comfort and reduce the effects of distress, risk perception and birth anxiety.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 64
• Est. completion date: December 30, 2023
• Est. primary completion date: December 9, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

Inclusion Criteria:

• Ability to speak Turkish,

• First pregnancy

• Agreeing to participate in the study

• 14 weeks pregnant

Exclusion Criteria:

• Pregnant women who do not continue the program.

• Attending a pregnancy education class

Related Conditions & MeSH terms

• Pregnant Women

Intervention

Other:
• control
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.
• 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.

Locations

Country	Name	City	State
Turkey	TurkishMoHKahramanmarasPH	Kahramanmaras

Sponsors (1)

Lead Sponsor	Collaborator
Turkish Ministry of Health, Kahramanmaras Provincial Health Directorate

Country where clinical trial is conducted

Turkey, 

References & Publications (20)

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. — View Citation

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. — View Citation

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. — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 20 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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