ClinicalTrials.gg
Not yet recruitingNCT07823361trauma-informeUpdated Sep 16, 2026

The Effects of Trauma-informed Care Organization on Birth Professionals and Women's Experiences of Trauma.

An interventional study of trauma-informed care training in Post-Traumatic Stress Disorder and Psychological Trauma, sponsored by Tarsus University. Not yet recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-16.

Sponsored by Tarsus University · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
345
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

Childbirth is generally considered a positive and meaningful life event; however, it may also be experienced as psychologically distressing or traumatic. Traumatic birth experiences may be associated with post-traumatic stress symptoms, including intrusive memories, avoidance, emotional distress, and heightened physiological arousal. Such experiences may affect maternal mental health, maternal-infant bonding, breastfeeding, and future reproductive decisions. Healthcare professionals who are repeatedly exposed to traumatic birth events may also experience secondary traumatic stress, burnout, and reduced job satisfaction.

Trauma-informed care (TIC) is an approach that recognizes the widespread and potentially long-lasting effects of trauma and seeks to minimize the risk of re-traumatization during healthcare interactions. Core principles include psychological and emotional safety, respectful and trauma-sensitive communication, informed consent, empowerment, collaboration, and support for individual autonomy and dignity. Within maternity care, a trauma-informed approach requires healthcare professionals to recognize that women may have previous or birth-related traumatic experiences, including experiences that have not been disclosed.

Effective implementation of TIC requires an organizational approach rather than isolated educational interventions. Women interact with multiple healthcare professionals and support personnel throughout maternity care, from admission to discharge. Therefore, communication practices, attitudes, institutional procedures, and the overall care environment may influence women's childbirth experiences. The present study will implement an organization-wide trauma-informed care model at Tarsus State Hospital involving organizational leaders, healthcare professionals, and support personnel.

The intervention will include educational programs specifically developed for different professional groups. Organizational leaders will receive training on institutional strategies for implementing trauma-informed care, recognizing secondary traumatic stress among staff, and developing sustainable action plans for integrating TIC principles into maternity services.

Healthcare professionals involved in maternity and perinatal care, including midwives, nurses, obstetricians, psychologists, psychiatrists, and social workers, will participate in a multi-module training program. Training will address recognition of psychological and birth-related trauma, trauma-sensitive communication, prevention of re-traumatization, informed consent, women's autonomy and dignity, and integration of trauma-informed principles into routine maternity care.

Support personnel who interact with women and families during hospital services will receive targeted training focusing on respectful communication, awareness of trauma-related sensitivities, and appropriate interactions with women receiving maternity care.

Educational activities will use interactive learning methods, including case discussions, group exercises, role-playing scenarios, and problem-solving activities. In addition to individual-level knowledge and awareness, the intervention is intended to support organizational changes that facilitate the sustainable integration of trauma-informed principles into maternity services.

The study will evaluate the effects of this organization-wide intervention on both healthcare professionals and women receiving maternity care. Outcomes will focus on changes related to trauma-informed care among professionals and trauma-related and childbirth experiences among women. The findings are expected to provide evidence regarding the feasibility and potential effects of implementing trauma-informed care as an organizational model within maternity services.

02

Conditions studied

  • Post-Traumatic Stress Disorder
  • Psychological Trauma

Keywords

  • Trauma-Informed Care
  • Traumatic Childbirth
  • Birth Trauma
  • Maternity Care
  • Perinatal Care
03

In context

Stress Disorders, Post-Traumatic

2,682 studies on the registry are indexed under Stress Disorders, Post-Traumatic; 601 are open to participants now.

This study's planned enrollment of 345 is above the median of 69 across 2,196 interventional studies indexed under Stress Disorders, Post-Traumatic.

Browse Stress Disorders, Post-Traumatic studies →

Lead sponsor

Tarsus University is the lead sponsor of 82 studies on the registry; 29 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Women:

  • Aged 18 years or older.
  • Giving birth at Tarsus State Hospital during the study period.
  • Providing voluntary .

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.

Exclusion criteria

Exclusion Criteria:

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.

Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
345 participants (estimated)

Study arms

  • No intervention
    Control Group

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

  • Experimental
    Trauma-Informed Care Intervention

    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

  • Behavioraltrauma-informed care training

    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.

06

What researchers measure

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.

    Time frame: 4-6 weeks postpartum

Secondary outcomes

  1. Trauma-related stress symptoms in maternity healthcare professionals

    Trauma-related stress symptoms among maternity healthcare professionals will be assessed using the City Birth Trauma Scale - Maternal Health Professional Version. The total score ranges from \[minimum score\] to \[maximum score\], with higher scores indicating greater severity of trauma-related stress symptoms and therefore a worse outcome.

    Time frame: 40-60 days after completion of the training program.

07

Study locations

1 site
  • Tarsus State Hospital Tarsus, Mersin, Türkiye
    Mersin, Tarsus 33400, Turkey (Türkiye)
08

References and documents

Individual participant data

Plan to share: No — Individual participant data will not be publicly shared due to participant confidentiality and data protection considerations.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Sep 2026; primary completion for May 2027, 7 months later.

Of 1,064 non-industry interventional studies with no phase under Stress Disorders, Post-Traumatic, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 53. This study's planned 7 months is below that.

Counting every sponsor, half of 1,092 studies reached it within 34 months; a quarter within 17 and three quarters within 53.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 13, 2026
First posted
Sep 16, 2026
StartEst.
Sep 30, 2026
Primary completionEst.
May 15, 2027
CompletionEst.
May 1, 2028
Last update
Sep 16, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 16, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07823361
Lead sponsor
Tarsus University
Collaborators
The Scientific and Technological Research Council of Turkey
Responsible party
Özlem KOÇ (Principal Investigator, Tarsus University) — Principal investigator
First posted
Sep 16, 2026
Start date
Sep 30, 2026 (estimated)
Primary completion
May 15, 2027 (estimated)
Completion
May 1, 2028 (estimated)
Last update
Sep 16, 2026

Study contacts

Özlem KOÇ, PhD
Contact
ozlemkoc@tarsus.edu.tr
+905520839594 ext. +90 324 600 00
Özlem KOÇ, PhD
principal investigator · Tarsus University, Faculty of Health Sciences, Department of Midwifery

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.

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