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

15 de septiembre de 2026 actualizado por: Özlem KOÇ, Tarsus University

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.

Descripción general del estudio

Estado

Aún no reclutando

Descripción detallada

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.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

345

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

  • Nombre: Özlem KOÇ, PhD
  • Número de teléfono: +90 324 600 00 +905520839594
  • Correo electrónico: ozlemkoc@tarsus.edu.tr

Ubicaciones de estudio

    • Tarsus
      • Mersin, Tarsus, Turquía (Türkiye), 33400
        • Tarsus State Hospital Tarsus, Mersin, Türkiye
        • Contacto:

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Descripción

Inclusion Criteria:

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.

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.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Prevención
  • Asignación: No aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Sin intervención: 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.
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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Birth-related post-traumatic stress symptoms
Periodo de tiempo: 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.
4-6 weeks postpartum

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Trauma-related stress symptoms in maternity healthcare professionals
Periodo de tiempo: 40-60 days after completion of the training program.
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.
40-60 days after completion of the training program.

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Investigadores

  • Investigador principal: Özlem KOÇ, PhD, Tarsus University, Faculty of Health Sciences, Department of Midwifery

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

30 de septiembre de 2026

Finalización primaria (Estimado)

15 de mayo de 2027

Finalización del estudio (Estimado)

1 de mayo de 2028

Fechas de registro del estudio

Enviado por primera vez

13 de marzo de 2026

Primero enviado que cumplió con los criterios de control de calidad

15 de septiembre de 2026

Publicado por primera vez (Actual)

16 de septiembre de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

16 de septiembre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

15 de septiembre de 2026

Última verificación

1 de marzo de 2026

Más información

Términos relacionados con este estudio

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Descripción del plan IPD

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

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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