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

October 26, 2023 updated by: Mine Gokduman Keles, Turkish Ministry of Health, Kahramanmaras Provincial Health Directorate

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.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

64

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Turkey
      • Kahramanmaraş, Turkey, 46050
        • Recruiting
        • TurkishMoHKahramanmarasPH
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Workgroup
.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

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: 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prenatal Comfort Scale
Time Frame: hrough study completion, an average of 1 week
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
Time Frame: 15 minutes before the training, 15 minutes after the training is completed
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
Time Frame: 15 minutes before the training, 15 minutes after the training is completed
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:
Time Frame: 15 minutes before the training, 15 minutes after the training is completed
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Turkish Ministry of Health, Kahramanmaras Provincial Health Directorate

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 9, 2023

Primary Completion (Estimated)

December 9, 2023

Study Completion (Estimated)

December 30, 2023

Study Registration Dates

First Submitted

October 20, 2023

First Submitted That Met QC Criteria

October 26, 2023

First Posted (Actual)

November 1, 2023

Study Record Updates

Last Update Posted (Actual)

November 1, 2023

Last Update Submitted That Met QC Criteria

October 26, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • TurkishHKahramanmara

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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