The Effect of Midwife-led Education Based on Pender's Health Promotion Model on Perinatal Mental Health of Migrant Women

Mental Health Clinical Trial

Official title:

The Effect of Midwife-led Education Based on Pender's Health Promotion Model on Perinatal Mental Health of Migrant Women

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05659030
• Other study ID #: 04.11.2022/34
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2023
• Est. completion date: August 1, 2024

Study information

• Verified date: December 2022
• Source: Cukurova University
• Contact: Ayseren Cevik, Msc
• Phone: +90 (322) 338 64 84
• Email: acevik[@]cu.edu.tr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Objective: Migration status is one of the most important factors affecting perinatal mental health. National and international organizations emphasize the need to improve perinatal mental health. This research was planned as a pretest-posttest control group experimental model in order to determine the effect of midwifery education based on Pender's Health Promotion Model on the perinatal mental health of migrant women under the leadership of midwives.

Materials and Methods: The population of this study, which will be conducted in randomized controlled experimental type, will be Syrian immigrant pregnant women living in Seyhan district. The number of samples will be calculated by G*power analysis, and 52 participants in the experimental group and 52 participants in the control group will be included. Single-blind random assignment and block randomization will be used to avoid selection bias. The research will be conducted in the form of pre-test and post-test. The pre-test will be applied during the pregnancy period before the education and the post-test will be applied in the postpartum period after the education. 3 modules of training on perinatal mental health will be given to the experimental group in order to eliminate the lack of knowledge of women and to raise awareness. The control group will be left to routine clinical care. Data; Introductory Information Form, Perinatal Mental Health Education Evaluation Form, Edinburgh Postpartum Depression Scale and Perinatal Anxiety Screening Scale will be collected. Statistical Program for Social Science 22 will be used in data analysis. The independent variable of the research is perinatal mental health education based on Pender's Health Promotion Model. The dependent variable is the introductory characteristics of women, questions about perinatal mental health education, anxiety and depression levels. The data will be analyzed with appropriate analysis methods after performing normality tests.

Description:

Migration status is one of the most important factors affecting perinatal mental health. National and international organizations emphasize the need to improve perinatal mental health. This research was planned as a pretest-posttest control group experimental model in order to determine the effect of midwife-led education based on Pender's Health Promotion Model on the perinatal mental health of immigrant women. This research is based on two main hypotheses:

H0: Midwife-led education based on Pender's Health Promotion Model does not affect perinatal mental health.

H1: Midwife-led education based on Pender's Health Promotion Model affects perinatal mental health.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 104
• Est. completion date: August 1, 2024
• Est. primary completion date: July 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

Inclusion Criteria:

• Willingness to participate in the research,

• 18 years and over,

• Being in the second trimester of pregnancy,

• Born in Syria,

• The mother tongue is Arabic,

• Preferably at B1 level in Turkish.

Exclusion Criteria:

• Having a risky pregnancy,

• Having a diagnosis of mental illness,

• Psychological counseling, psychotherapy, etc. using the services.

Related Conditions & MeSH terms

• Mental Health
• Perinatal Care

Intervention

Other:
• Education
In order to develop the training material, first of all, a literature review will be made and a training booklet will be prepared. The training booklet will be submitted to expert opinion and a pilot application will be made by giving its final form. The training content is based on Pender's Health Promotion Model, which consists of 3 components.

Locations

Country	Name	City	State
Turkey	Cukurova University	Adana

Sponsors (1)

Lead Sponsor	Collaborator
Cukurova University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Perinatal Mental Health Education Evaluation Form	Change from the level of knowledge and awareness about perinatal mental health at 6 months	pre-intervention, immediately after the intervention, after 1 month. An increase in the score is interpreted as an increase in the level of knowledge and awareness about perinatal mental.
Primary	Edinburgh Postnatal Depression Scale	Change from the prenatal and postnatal depression at 6 months	pre-intervention, immediately after the intervention, after 1 month. An increase in the score is interpreted as an increase in perinatal depression symptoms.
Primary	Perinatal Anxiety Screening Scale	Change from prenatal and postnatal anxiety at 6 months	pre-intervention, immediately after the intervention, after 1 month. An increase in the score is interpreted as an increase in perinatal anxiety symptoms.