NCT07823361

Brief Summary

This study aims to evaluate the effects of integrating trauma-informed care (TIC) into the organizational structure of maternity services on women giving birth and healthcare professionals involved in perinatal care. The study will be conducted at Tarsus State Hospital and will implement a systematic, organization-wide TIC approach designed to improve the quality and psychological safety of maternity care. Trauma-informed care recognizes the potential impact of previous and birth-related trauma and seeks to prevent re-traumatization through respectful communication, emotional safety, informed consent, empowerment, collaborative decision-making, and support for women's autonomy and dignity. In maternity services, these principles may contribute to more positive childbirth experiences while also supporting healthcare professionals who may experience secondary traumatic stress through repeated exposure to traumatic events. The intervention will involve multiple groups within the hospital, including organizational leaders, healthcare professionals, and support personnel. Organizational leaders will receive training on institutional implementation of TIC and the development of sustainable organizational strategies. Healthcare professionals, including midwives, nurses, obstetricians, psychologists, psychiatrists, and social workers, will receive training on recognizing trauma, trauma-sensitive communication, and integrating TIC principles into routine maternity care. Support personnel will receive training focused on respectful communication and awareness of trauma-related sensitivities. Educational activities will include case discussions, group exercises, role-playing, and problem-solving sessions. The study will evaluate whether this organization-wide approach contributes to improved trauma-informed practices among healthcare professionals and more positive experiences among women receiving maternity care.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
345

participants targeted

Target at P75+ for not_applicable

Timeline
19mo left

Started Sep 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress1%
Sep 2026May 2028

First Submitted

Initial submission to the registry

March 13, 2026

Completed
6 months until next milestone

First Posted

Study publicly available on registry

September 16, 2026

Completed
14 days until next milestone

Study Start

First participant enrolled

September 30, 2026

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2027

Expected
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2028

Last Updated

September 16, 2026

Status Verified

March 1, 2026

Enrollment Period

8 months

First QC Date

March 13, 2026

Last Update Submit

September 15, 2026

Conditions

Keywords

Trauma-Informed CareTraumatic ChildbirthBirth TraumaMaternity CarePerinatal Care

Outcome Measures

Primary Outcomes (1)

  • Birth-related post-traumatic stress symptoms

    Birth-related post-traumatic stress symptoms will be assessed using the City Birth Trauma Scale (City BiTS). The scale assesses post-traumatic stress symptoms related to childbirth. The total score ranges from 0 to 60, with higher scores indicating greater severity of birth-related post-traumatic stress symptoms and therefore a worse outcome.

    4-6 weeks postpartum

Secondary Outcomes (1)

  • Trauma-related stress symptoms in maternity healthcare professionals

    40-60 days after completion of the training program.

Study Arms (2)

Control Group

NO INTERVENTION

Women giving birth during the pre-intervention period, before implementation of the organization-wide trauma-informed care program.

Trauma-Informed Care Intervention

EXPERIMENTAL

Women giving birth during the post-intervention period, after implementation of the organization-wide trauma-informed care program for maternity service personnel.

Behavioral: trauma-informed care training

Interventions

An organization-wide trauma-informed care program involving training of organizational leaders, healthcare professionals, and support personnel to promote trauma-sensitive communication, psychological safety, informed consent, women's autonomy, and prevention of re-traumatization in maternity services.

Trauma-Informed Care Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Women:
  • Aged 18 years or older.
  • Giving birth at Tarsus State Hospital during the study period.
  • Providing voluntary informed consent.
  • Healthcare professionals, organizational leaders, and support staff:
  • Aged 18 years or older.
  • Working in maternity or related services at Tarsus State Hospital.
  • Participating in the trauma-informed care intervention according to their professional role.
  • Providing voluntary informed consent.

You may not qualify if:

  • Women:
  • Severe postpartum complications preventing participation or completion of study assessments.
  • Incomplete study assessments.
  • Healthcare professionals, organizational leaders, and support staff:
  • Failure to complete the required training or study assessments. Incomplete study assessments.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tarsus State Hospital Tarsus, Mersin, Türkiye

Mersin, Tarsus, 33400, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Stress Disorders, Post-TraumaticPsychological TraumaBirth Injuries

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental DisordersInfant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesWounds and Injuries

Study Officials

  • Özlem KOÇ, PhD

    Tarsus University, Faculty of Health Sciences, Department of Midwifery

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Masking Details
Arm 1: Control cohort (women giving birth before implementation of trauma-informed care training) Arm 2: Intervention cohort (women giving birth after implementation of trauma-informed care training)
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 13, 2026

First Posted

September 16, 2026

Study Start

September 30, 2026

Primary Completion (Estimated)

May 15, 2027

Study Completion (Estimated)

May 1, 2028

Last Updated

September 16, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be publicly shared due to participant confidentiality and data protection considerations.

Locations