Post-Traumatic Stress Disordertrauma-informeNCT07823361
The Effects of Trauma-informed Care Organization on Birth Professionals and Women's Experiences of Trauma.
A study testing trauma-informed care training in people with Post-Traumatic Stress Disorder and Psychological Trauma, run by Tarsus University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-Traumatic Stress Disorder, Psychological Trauma
- What is being tested?
- trauma-informed care training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 345 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Sep 2026to 1 May 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 9Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Tarsus State Hospital Tarsus, Mersin, Türkiye
Mersin, Tarsus, 33400
Özlem KOÇ, PhD, 05520839594, ozlemkoc@tarsus.edu.tr
About this study
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.
Read more
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.
- Being tested
- trauma-informed care training
- Keywords
- Trauma-Informed Care, Traumatic Childbirth, Birth Trauma, Maternity Care, Perinatal Care
- Medical subject headings
- Stress Disorders, Post-Traumatic, Psychological Trauma, Birth Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
trauma-informed care trainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: trauma-informed care training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 40-60 days after completion of the training program.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2026
- Study start30 Sep 2026 (estimated)
- Primary completion15 May 2027 (estimated)
- Study completion1 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-Traumatic Stress DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 345 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tarsus University
- Sponsor type
- University, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Responsible party
- Principal investigator, Özlem KOÇ, Tarsus University
- Investigators
- Özlem KOÇ, PhD, Principal investigator, Tarsus University, Faculty of Health Sciences, Department of Midwifery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07823361
- Sponsor's protocol ID
- TUBİTAK-125C090
- Acronym
- trauma-informe
- Status last verified
- Mar 2026
- First submitted
- 13 Mar 2026
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be publicly shared due to participant confidentiality and data protection considerations.
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Trauma-informed Care Organization on Birth Professionals and Women's Experiences of Trauma.
- ClinicalTrials.gov ID
- NCT07823361
- Acronym / sponsor ID
- trauma-informe / TUBİTAK-125C090
- Keywords
- Trauma-Informed Care, Traumatic Childbirth, Birth Trauma, Maternity Care, Perinatal Care
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 345 participants (estimated)
- Lead sponsor
- Tarsus UniversityUniversity, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Study start
- 30 Sep 2026 (estimated)
- Primary completion
- 15 May 2027 (estimated)
- Study completion
- 1 May 2028 (estimated)
- First posted
- 16 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: trauma-informed care trainingWomen giving birth during the post-intervention period, after implementation of the organization-wide trauma-informed care program for maternity service personnel. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Aged 18 years or older.
- Giving birth at Tarsus State Hospital during the study period.
- Providing voluntary informed consent.
- Aged 18 years or older.
- Working in maternity or related services at Tarsus State Hospital.
Key exclusion criteria (5 listed)
- Severe postpartum complications preventing participation or completion of study assessments.
- Incomplete study assessments.
- -Failure to complete the required training or study assessments. Incomplete study assessments.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| trauma-informed care trainingAn 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. | Behavioural | Trauma-Informed Care Intervention |
Primary outcome
Birth-related post-traumatic stress symptoms
Time frame: 4-6 weeks postpartum
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.
1 secondary outcome
Trauma-related stress symptoms in maternity healthcare professionals
Time frame: 40-60 days after completion of the training program.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be publicly shared due to participant confidentiality and data protection considerations.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Özlem KOÇ, PhD principal investigator
Tarsus University, Faculty of Health Sciences, Department of Midwifery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing trauma-informed care training in people with Post-Traumatic Stress Disorder and Psychological Trauma, run by Tarsus University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Özlem KOÇ, PhD (+905520839594 ext. +90 324 600 00, ozlemkoc@tarsus.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Birth-related post-traumatic stress symptoms (time frame: 4-6 weeks postpartum). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2026.