The Effect of Midwife-led Education Based on Pender's Health Promotion Model on Perinatal Mental Health of Migrant Women
1 other identifier
interventional
106
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 5, 2022
CompletedFirst Posted
Study publicly available on registry
December 21, 2022
CompletedStudy Start
First participant enrolled
June 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 9, 2024
CompletedJanuary 31, 2025
January 1, 2025
1.4 years
December 5, 2022
January 29, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Perinatal Mental Health Education Evaluation Form
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.
pre-intervention, immediately after the intervention, after 1 month.
Edinburgh Postnatal Depression Scale
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.
pre-intervention, immediately after the intervention, after 1 month.
Perinatal Anxiety Screening Scale
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.
pre-intervention, immediately after the intervention, after 1 month.
Study Arms (2)
Experimental
EXPERIMENTALIt 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.
Control
NO INTERVENTIONRoutine 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Cukurova University
Adana, Turkey (Türkiye)
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ayseren Cevik, Msc
Cukurova University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Lecturer
Study Record Dates
First Submitted
December 5, 2022
First Posted
December 21, 2022
Study Start
June 1, 2023
Primary Completion
November 1, 2024
Study Completion
December 9, 2024
Last Updated
January 31, 2025
Record last verified: 2025-01
Data Sharing
- IPD Sharing
- Will not share