- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT07823361
The Effects of Trauma-informed Care Organization on Birth Professionals and Women's Experiences of Trauma. (trauma-informe)
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.
Visão geral do estudo
Status
Intervenção / Tratamento
Descrição detalhada
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 estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Özlem KOÇ, PhD
- Número de telefone: +90 324 600 00 +905520839594
- E-mail: ozlemkoc@tarsus.edu.tr
Locais de estudo
-
-
Tarsus
-
Mersin, Tarsus, Turquia (Türkiye), 33400
- Tarsus State Hospital Tarsus, Mersin, Türkiye
-
Contato:
- Özlem KOÇ, PhD
- Número de telefone: 05520839594
- E-mail: ozlemkoc@tarsus.edu.tr
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Prevenção
- Alocação: Não randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Sem intervenção: 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.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Birth-related post-traumatic stress symptoms
Prazo: 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 resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Trauma-related stress symptoms in maternity healthcare professionals
Prazo: 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
Patrocinador
Investigadores
- Investigador principal: Özlem KOÇ, PhD, Tarsus University, Faculty of Health Sciences, Department of Midwifery
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Transtornos Relacionados a Traumas e Estressores
- Transtornos Mentais, Desordem Mental
- Ferimentos e Lesões
- Lactente, Recém Nascido, Doenças
- Transtornos de Estresse Traumático
- Doenças e Anormalidades Congênitas, Hereditárias e Neonatais
- Trauma psicológico
- Transtornos de Estresse Pós-Traumático
- Lesões de Nascimento
Outros números de identificação do estudo
- TUBİTAK-125C090
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .