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

Sponsor

Cukurova University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05659030

Collaborator

(none)

104

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Mental Health Perinatal Care	Other: Education	N/A

Detailed 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

104 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Prevention

Official Title:

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

Anticipated Study Start Date :

Jul 1, 2023

Anticipated Primary Completion Date :

Jul 1, 2023

Anticipated Study Completion Date :

Aug 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Experimental It is planned to provide training on perinatal mental health to the experimental group in order to eliminate the lack of knowledge of women and to raise awareness. The pre-test will be applied during the pregnancy period before the training. These trainings, which will be held during pregnancy, consist of 3 modules. A training booklet in their preferred language (Turkish or Arabic) will be distributed to women at the end of each module. In addition, the effectiveness of the training will be evaluated at the end of each module and the knowledge deficiencies of women will be eliminated. The trainings will be carried out in the form of group training of 10-12 people, taking into account the physical conditions of the environment. A module training will be given every week and the training will be completed within three weeks. The effectiveness of the training will be evaluated in the postpartum period with the post-test.	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.
No Intervention: Control Routine clinical care will be given to women in the control group. The pre-test will be applied during the pregnancy period and the post-test will be applied in the postpartum period. At the end of the post-test, three module training booklets will be distributed to the women in their preferred language (Turkish or Arabic). In line with their needs, the information deficiencies they request will be corrected.

Arm

Intervention/Treatment

Experimental: Experimental

It is planned to provide training on perinatal mental health to the experimental group in order to eliminate the lack of knowledge of women and to raise awareness. The pre-test will be applied during the pregnancy period before the training. These trainings, which will be held during pregnancy, consist of 3 modules. A training booklet in their preferred language (Turkish or Arabic) will be distributed to women at the end of each module. In addition, the effectiveness of the training will be evaluated at the end of each module and the knowledge deficiencies of women will be eliminated. The trainings will be carried out in the form of group training of 10-12 people, taking into account the physical conditions of the environment. A module training will be given every week and the training will be completed within three weeks. The effectiveness of the training will be evaluated in the postpartum period with the post-test.

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.

No Intervention: Control

Routine clinical care will be given to women in the control group. The pre-test will be applied during the pregnancy period and the post-test will be applied in the postpartum period. At the end of the post-test, three module training booklets will be distributed to the women in their preferred language (Turkish or Arabic). In line with their needs, the information deficiencies they request will be corrected.

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 35 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cukurova University	Adana		Turkey

Sponsors and Collaborators

Cukurova University

Investigators

Principal Investigator: Ayseren Cevik, Msc, Cukurova University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ayseren Cevik, Lecturer, Cukurova University

ClinicalTrials.gov Identifier:

NCT05659030

Other Study ID Numbers:

04.11.2022/34

First Posted:

Dec 21, 2022

Last Update Posted:

Jan 3, 2023

Last Verified:

Dec 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Ayseren Cevik, Lecturer, Cukurova University

Study Results

No Results Posted as of Jan 3, 2023