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- Ensayo clínico NCT07699887
The Effect of Web-Based Compassion-Focused Structured Writing Programs on Well-Being in Midwives Working in Delivery Rooms
11 de julio de 2026 actualizado por: Gozde Gokce Isbir, Mersin University
The Effect of Web-Based Compassion-Focused Writing Program and Reflective Writing Program on Psychological Outcomes in Midwives Working in Delivery Rooms: A Randomized Controlled Trial
This randomized controlled trial aims to compare the effects of a web-based compassion-focused writing program and a reflective writing program on psychological well-being, self-compassion, postpartum trauma-related stress symptoms, and post-traumatic growth in midwives working in delivery rooms.
Descripción general del estudio
Estado
Aún no reclutando
Intervención / Tratamiento
Descripción detallada
This study is planned as a single-blind, parallel-group randomized controlled trial to evaluate the effects of two different writing-based interventions on psychological outcomes in midwives working in delivery rooms.
During the childbirth process, midwives may occasionally witness traumatic events, which may lead to secondary traumatic stress, burnout, and various psychological difficulties.
The literature indicates that expressive writing, reflective writing, and compassion-focused writing approaches contribute to individuals' ability to make sense of traumatic experiences, enhance emotional regulation skills, and support psychological well-being.
Accordingly, this study aims to examine the effects of writing-based interventions that may support the psychological resilience of midwives.
A total of 90 midwives who meet the inclusion criteria will be included in the study and randomly assigned to two groups using a computer-generated random number sequence.
One group will receive a web-based compassion-focused writing program, while the other group will receive a web-based reflective writing program.
Both programs will consist of five sessions conducted once per week via an online platform.
Data will be collected using a Personal Information Form, Psychological Well-Being Scale, Self-Compassion Scale, City Birth Trauma Scale, and Post-Traumatic Growth Scale - Short Form.
Measurements will be conducted before the intervention, immediately after the completion of the program, and during the follow-up period.
Additionally, after each session, participants will complete a brief questionnaire to evaluate their writing experience.
The collected data will be analyzed using appropriate statistical methods to compare the effects of both writing programs on psychological well-being, self-compassion, post-traumatic growth, and trauma-related stress symptoms.
Tipo de estudio
Intervencionista
Inscripción (Estimado)
90
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: Gözde Gökçe İsbir
- Número de teléfono: +905057782319
- Correo electrónico: gozdegokce@gmail.com
Copia de seguridad de contactos de estudio
- Nombre: Zehra Yıldırım
- Número de teléfono: +905464313760
- Correo electrónico: ebezehrayldrm@gmail.com
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
Sí
Descripción
Inclusion Criteria:
- Working as a midwife in a delivery room between November 1, 2025, and February 15, 2027
- Native Turkish speaker
- Female
- Aged between 18-65 years
- Having at least a bachelor's degree in midwifery
- Having at least three years of delivery room experience
- No diagnosed psychological or psychiatric disorder
- Having the technical infrastructure to use a web-based program
- Ability to use a smartphone, tablet, or computer
- Voluntary agreement to participate in the study
Exclusion Criteria:
- Not working in a delivery room during the specified dates
- Not a native Turkish speaker
- Under 18 or over 65 years of age
- Male
- Changing clinical unit during the study
- Not completing all five intervention sessions
- Working less than 40 hours per week in the delivery room due to leave or reassignment
- Voluntary withdrawal from the study at any stage
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: Otro
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Compassion-Focused Writing Program
Participants assigned to this group will complete a five-week web-based compassion-focused writing program consisting of structured writing exercises aimed at enhancing self-compassion, increasing empathy, supporting emotional awareness, and strengthening coping skills related to challenging birth experiences.
Sessions will be conducted once per week via an online platform.
|
The web-based compassion-focused writing program consists of five structured writing sessions designed to enhance self-compassion, empathy, emotional awareness, and coping skills related to challenging birth experiences.
|
|
Comparador de placebos: Reflective Writing Program
Participants in this group will complete a five-week web-based reflective writing program consisting of structured writing exercises designed to encourage reflection on professional experiences, emotional responses, and thoughts related to delivery room practices.
Sessions will be conducted once per week via an online platform.
|
The web-based reflective writing program consists of structured online writing exercises designed to facilitate reflective thinking, emotional expression, and self-awareness.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Psychological Well-Being
Periodo de tiempo: Within 24 hours before the intervention, within 24 hours after the intervention, and 6-8 weeks after the intervention
|
Participants' psychological well-being will be assessed using the Psychological Well-Being Scale developed by Diener et al. (2010) to measure socio-psychological well-being.
The scale consists of 8 items rated on a 7-point Likert scale ranging from 1 ("Strongly disagree") to 7 ("Strongly agree").
Total scores range from 8 to 56, with higher scores indicating greater psychological well-being and stronger psychological resources.
The Turkish version of the scale demonstrated good internal consistency, with a Cronbach's alpha coefficient of 0.80 (Telef, 2013).
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Within 24 hours before the intervention, within 24 hours after the intervention, and 6-8 weeks after the intervention
|
|
Self-Compassion
Periodo de tiempo: Within 24 hours before the intervention, within 24 hours after the intervention, and 6-8 weeks after the intervention
|
Participants' self-compassion will be assessed using the Self-Compassion Scale developed by Neff (2003).
The scale measures individuals' levels of self-kindness, acceptance, and compassion toward themselves.
The Turkish version consists of 24 items rated on a 5-point Likert scale.
It includes six subscales: self-kindness, self-judgment, common humanity, isolation, mindfulness, and over-identification.
Total scores range from 24 to 120, with higher scores indicating greater self-compassion.
The Turkish version demonstrated good reliability, with a Cronbach's alpha coefficient of 0.89 and a test-retest reliability coefficient of 0.83 (Deniz, Kesici, & Sümer, 2008).
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Within 24 hours before the intervention, within 24 hours after the intervention, and 6-8 weeks after the intervention
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Birth-Related Traumatic Stress Symptoms
Periodo de tiempo: Within 24 hours before the intervention and 6-8 weeks after the intervention
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Participants' birth-related traumatic stress symptoms will be assessed using the City Birth Trauma Scale - Maternal Health Professional Version, developed by McInnes et al. (2025).
The scale is based on the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition criteria for post-traumatic stress disorder and is designed to assess birth-related traumatic stress symptoms among maternal healthcare professionals providing care during the antenatal, intrapartum, and postpartum periods.
Total PTSD symptom scores range from 0 (minimum) to 60 (maximum), with higher scores indicating more severe birth-related post-traumatic stress disorder symptoms.The scale consists of 29 items, with higher total scores indicating more severe birth-related post-traumatic stress disorder symptoms.
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Within 24 hours before the intervention and 6-8 weeks after the intervention
|
|
Posttraumatic Growth
Periodo de tiempo: Within 24 hours before the intervention and 6-8 weeks after the intervention
|
Participants' posttraumatic growth will be assessed using the Posttraumatic Growth Inventory-Short Form, developed by Platte et al. (2023).
The scale consists of 10 items rated on a 6-point Likert scale, with total scores ranging from 0 to 50.
Higher scores indicate greater positive psychological growth following a traumatic or highly stressful experience.
The original version demonstrated good internal consistency, with a Cronbach's alpha coefficient of 0.88.
The Turkish version also demonstrated good reliability, with a Cronbach's alpha coefficient of 0.81 (Türk et al., 2025).
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Within 24 hours before the intervention and 6-8 weeks after the intervention
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- Uddin N, Ayers S, Khine R, Webb R. The perceived impact of birth trauma witnessed by maternity health professionals: A systematic review. Midwifery. 2022 Nov;114:103460. doi: 10.1016/j.midw.2022.103460. Epub 2022 Aug 13.
- Hajiesmaello M, Hajian S, Riazi H, Majd HA, Yavarian R. Secondary traumatic stress in iranian midwives: stimuli factors, outcomes and risk management. BMC Psychiatry. 2022 Jan 24;22(1):56. doi: 10.1186/s12888-022-03707-7.
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)
1 de octubre de 2026
Finalización primaria (Estimado)
1 de noviembre de 2026
Finalización del estudio (Estimado)
15 de febrero de 2027
Fechas de registro del estudio
Enviado por primera vez
7 de julio de 2026
Primero enviado que cumplió con los criterios de control de calidad
7 de julio de 2026
Publicado por primera vez (Actual)
13 de julio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
14 de julio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
11 de julio de 2026
Última verificación
1 de julio de 2026
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- ZYildirim
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
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
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