NCT05659030

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
106

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2023

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
16 days until next milestone

First Posted

Study publicly available on registry

December 21, 2022

Completed
5 months until next milestone

Study Start

First participant enrolled

June 1, 2023

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 9, 2024

Completed
Last Updated

January 31, 2025

Status Verified

January 1, 2025

Enrollment Period

1.4 years

First QC Date

December 5, 2022

Last Update Submit

January 29, 2025

Conditions

Keywords

Midwiferyhuman migrationmental healthperinatal care

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

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.

Other: Education

Control

NO INTERVENTION

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.

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.

Experimental

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPregnancy
Healthy VolunteersYes
Age GroupsAdult (18-64)

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)

Location

MeSH Terms

Conditions

Psychological Well-Being

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Personal SatisfactionBehavior

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation Characteristics

Study Officials

  • Ayseren Cevik, Msc

    Cukurova University

    PRINCIPAL INVESTIGATOR

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

Locations