- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07510555
El Efecto de un Programa de Reducción del Estrés Basado en la Atención Plena Aplicado a Mujeres Embarazadas Nulíparas
El efecto de un programa de reducción del estrés basado en la atención plena aplicado a mujeres embarazadas nulíparas sobre la ansiedad prenatal, la preocupación por la salud fetal y el bienestar psicológico
Mindfulness-based stress reduction programs are among the effective methods that can contribute to managing anxiety during pregnancy, strengthening mother-fetus interaction, and supporting psychological well-being. In this context, this study will examine the effect of a mindfulness-based stress reduction program on prenatal anxiety, fetal health concerns, and psychological well-being. The aim of this study is to determine the effect of a mindfulness-based stress reduction program applied to pregnant women who have not previously given birth on prenatal anxiety, fetal health concerns, and psychological well-being.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Pregnancy is a multifaceted period in a woman's life requiring physical and mental adjustment. During this process, women, especially those experiencing their first pregnancy, may experience prenatal anxiety and fetal health concerns due to uncertainties surrounding the birthing process and fetal health. Inadequate management of this anxiety and stress can negatively impact psychological well-being. Increased anxiety levels can also affect a mother's perception of the pregnancy and her expectations regarding childbirth. This situation can pose risks to both maternal health and fetal development. Therefore, the importance of psychologically supportive and structured interventions during pregnancy is increasing. Mindfulness-based approaches help individuals recognize their emotions and thoughts without judgment and cope with stress more effectively. Accordingly, this study aims to examine the effects of a mindfulness-based stress reduction program applied to nulliparous pregnant women on prenatal anxiety, fetal health concerns, and psychological well-being.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: ELİF KETEN EDİS, Assoc. Prof., PhD
- Número de teléfono: 4802 +903582115005
- Correo electrónico: elifketen05@gmail.com
Copia de seguridad de contactos de estudio
- Nombre: Mediha ÇAKMAK, BSc, RN
- Número de teléfono: +903582115005
- Correo electrónico: cakmakmediha8@gmail.com
Ubicaciones de estudio
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Amasya, Turquía (Türkiye), 05100
- Reclutamiento
- Amasya University Sabuncuoğlu Şerefeddin Training and Research Hospital
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Be 18 years of age and older,
- Have at least a primary school graduate
- Not having given birth before
- Be between the 12th and 28th weeks of pregnancy,
- Have internet access
Exclusion Criteria:
- Having any communication problems (language, hearing, vision, speech, etc.),
- Having a diagnosis of high-risk pregnancy, or having a diagnosis of a psychiatric illness (depression, psychosis, etc.)
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Intervention group
Pregnant women will be informed about the study and, after obtaining their written consent, pre-tests will be administered (Perinatal Anxiety Screening Scale, Fetal Health Anxiety Scale, Psychological Well-Being Scale). Then, women in the intervention group will receive a Mindfulness-based stress reduction program for 4 weeks, with two sessions per week. Four weeks after the pre-tests, post-tests (Perinatal Anxiety Screening Scale, Fetal Health Anxiety Scale, Psychological Well-being Scale) will be administered to women in both the intervention and control groups. |
Pregnant women will be informed about the study and, after obtaining their written consent, pre-tests will be administered. Then, women in the intervention group will receive a Mindfulness-based stress reduction program for 4 weeks, with two sessions per week. The program will cover topics such as the physiology of pregnancy and the fetus, physiological and psychological changes in the mother during pregnancy, fetal development, adaptation to the maternal role, the concept and foundations of mindfulness, mindfulness applications, the use of mindfulness in daily life, the mindfulness approach during pregnancy, stress management methods, and mindfulness, relaxation, and breathing exercises. The training sessions will be planned in a practice-based manner to encourage active participation. Mindfulness exercises will be practiced in the sessions, and participants will be given homework assignments to encourage the application of mindfulness skills to daily life. The trainings will be condu |
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Experimental: Control group
Pregnant women will be informed about the study and, after obtaining their written consent, pre-tests will be administered (Perinatal Anxiety Screening Scale, Fetal Health Anxiety Scale, Psychological Well-Being Scale). The control group will receive no intervention. Four weeks after the pre-tests, post-tests (Perinatal Anxiety Screening Scale, Fetal Health Anxiety Scale, Psychological Well-being Scale) will be administered to women in both the intervention and control groups. |
The control group will receive routine care. No interventions will be performed. Final tests will be administered 4 weeks after the preliminary tests. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Perinatal Anxiety Screening Scale
Periodo de tiempo: 4 week
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The Turkish validity and reliability study of the scale was conducted by Yazıcı et al. (2018). The scale consists of a total of 31 items and is a four-point Likert-type measurement tool. Items are scored with response options ranging from "never" to "always". Total scores above 16 indicate the presence of perinatal anxiety. As a result of the exploratory factor analysis, it was determined that the scale consists of four sub-dimensions. These sub-dimensions include: general anxiety and specific fears, perfectionism and control, social anxiety, general anxiety and adjustment difficulties, and acute anxiety, separation, and trauma. In the reliability analyses of the scale, Cronbach's alpha internal consistency coefficients were reported as 0.90, 0.89, 0.86, and 0.87 for the sub-dimensions, respectively. |
4 week
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Fetal Health Anxiety Scale
Periodo de tiempo: 4 week
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The validity and reliability study of the Turkish Fetal Health Anxiety Inventory was conducted by Gökbulut et al. (2024). This inventory aims to assess the anxiety levels experienced by pregnant women regarding the health of the fetus. The FSKE consists of 14 items in total, each containing four different statements to reflect the experiences of pregnant women. Scores obtained from the scale range from 0 to 42, with a higher total score indicating a higher level of fetal health anxiety. When the psychometric properties of the Turkish form of the scale were examined, it was observed that the internal consistency reliability was reported as Cronbach's alpha coefficient of 0.85. |
4 week
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Psychological Well-Being Scale
Periodo de tiempo: 4 week
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The Turkish adaptation of the scale was carried out by Telef (2013). The scale items have a seven-point Likert-type structure ranging from "strongly disagree" (1) to "strongly agree" (7). All statements in the scale are positively structured. The total scores that can be obtained from the scale range from 8 if all items are answered with "strongly disagree", and from 56 if all items are answered with "strongly agree". Higher scores indicate that the individual has higher levels of psychological resources and strengths. As a result of the reliability analyses of the scale, the Cronbach alpha internal consistency coefficient was determined as 0.80. |
4 week
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Director de estudio: ELİF KETEN EDİS, Amasya University
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- M-tez
Plan de datos de participantes individuales (IPD)
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Información sobre medicamentos y dispositivos, documentos del estudio
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