- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05659030
The Effect of Midwife-led Education Based on Pender's Health Promotion Model on Perinatal Mental Health of Migrant Women
January 29, 2025 updated by: Ayseren Cevik, Cukurova University
This randomized controlled experimental study was conducted to evaluate the effects of midwife-led Pender's Health Promotion Model-based education given to immigrant women on perinatal mental health.
The study was conducted with 52 intervention and 54 (n=48 in the post-test) control groups.
The study consisted of five interviews.
The intervention group received 3 modules of training, and the control group received routine clinical care.
Study Overview
Detailed Description
This randomized controlled experimental study was conducted to evaluate the effects of midwife-led Pender's Health Promotion Model-based education given to immigrant women on perinatal mental health.
The study was conducted with 52 intervention and 54 (48 in the post-test) control groups.
The study consisted of five interviews.
Data were collected using an introductory information form, perinatal mental health information form, Edinburgh Postnatal Depression Scale and Perinatal Anxiety Screening Scale.
Appropriate statistical analyses were performed in the analysis of data showing non-parametric distribution.
The intervention group received 3 modules of training, and the control group received routine clinical care.
The depression scores of the women in the intervention group did not show any significant difference over time, while the scores of the control group showed a significant difference.
Depression scores between the groups showed significant differences in the third and fourth interviews.
The anxiety scores of the women in the intervention and control groups showed a significant difference over time.
No significant difference was observed between the groups in terms of anxiety scores.
It can be said that the education based on Pender's Health Promotion Model has a protective and improving effect on perinatal health.
Study Type
Interventional
Enrollment (Actual)
106
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 Locations
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Adana, Turkey
- Çukurova University
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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
18 years to 35 years (Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Volunteer to participate in the study,
- Be over 18 years of age,
- Literate,
- Be of Syrian nationality and native Arabic,
- Be primiparous or multiparous,
- Be in the 28th-34th week of pregnancy.
Exclusion Criteria:
- Having a diagnosed risky pregnancy,
- Having a diagnosed mental illness (psychiatric report status, illness diagnosed by a psychiatrist and receiving treatment),
- Being benefited from psychological counseling, psychotherapy etc. services,
- Being excluded or excluded from the research at any stage of the research.
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: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
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.
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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.
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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Perinatal Mental Health Education Evaluation Form
Time Frame: pre-intervention, immediately after the intervention, after 1 month.
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Change from the level of knowledge and awareness about perinatal mental health.
An increase in the score is interpreted as an increase in the level of knowledge and awareness about perinatal mental.
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pre-intervention, immediately after the intervention, after 1 month.
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Edinburgh Postnatal Depression Scale
Time Frame: pre-intervention, immediately after the intervention, after 1 month.
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Change from the prenatal and postnatal depression.
An increase in the score is interpreted as an increase in perinatal depression symptoms.
A score of 12 and above indicates the presence of depression.
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pre-intervention, immediately after the intervention, after 1 month.
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Perinatal Anxiety Screening Scale
Time Frame: pre-intervention, immediately after the intervention, after 1 month.
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Change from prenatal and postnatal anxiety.
An increase in the score is interpreted as an increase in perinatal anxiety symptoms.
A score of 26 and above indicates the presence of anxiety.
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pre-intervention, immediately after the intervention, after 1 month.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Ayseren Cevik, Msc, Çukurova University
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)
June 1, 2023
Primary Completion (Actual)
November 1, 2024
Study Completion (Actual)
December 9, 2024
Study Registration Dates
First Submitted
December 5, 2022
First Submitted That Met QC Criteria
December 12, 2022
First Posted (Actual)
December 21, 2022
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
January 29, 2025
Last Verified
January 1, 2025
More Information
Terms related to this study
Other Study ID Numbers
- 04.11.2022/34
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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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