- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07820306
Roy Adaptation Model-Based Prenatal Education in Hypertensive Pregnant Women
The Effect of Roy Adaptation Model-Based Prenatal Education on Perceived Stress and Quality of Life in Hypertensive Pregnant Women
This study aims to evaluate the effect of Roy Adaptation Model-based prenatal education on perceived stress and quality of life in pregnant women with hypertensive disorders of pregnancy.
Pregnant women with hypertensive disorders who meet the eligibility criteria will be randomly assigned to either an intervention group or a control group. Participants in the intervention group will receive prenatal education based on the Roy Adaptation Model in two face-to-face sessions, one week apart. The control group will receive routine antenatal care. Blood pressure monitoring will be recommended for participants in both groups.
Perceived stress and quality of life will be assessed before the education and after the intervention. The study will investigate whether Roy Adaptation Model-based prenatal education helps reduce perceived stress and improve quality of life among pregnant women with hypertensive disorders.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Hypertensive disorders of pregnancy are high-risk pregnancy conditions that may be associated with various maternal and fetal complications and require close monitoring throughout pregnancy. In pregnant women diagnosed with hypertensive disorders, concerns related to the disease, uncertainty about the course of pregnancy, and concerns about fetal health may increase perceived stress and negatively affect quality of life. Therefore, in addition to medical follow-up, providing education and counseling tailored to the individual needs of pregnant women and supporting their adaptation to pregnancy and the disease are important components of care.
The Roy Adaptation Model is a theoretical model that explains how individuals respond to environmental stimuli and aims to support adaptation through nursing and midwifery care. The model addresses four modes of adaptation: physiological-physical, self-concept, role function, and interdependence. Addressing the effects of the physical and psychosocial changes associated with hypertensive pregnancy on these adaptation modes may contribute to better adaptation to the pregnancy process.
In this study, prenatal education for pregnant women with hypertensive disorders has been developed based on the Roy Adaptation Model. The educational content will include information about hypertensive disorders of pregnancy, blood pressure monitoring, healthy lifestyle behaviors during pregnancy, stress management, adaptation to physical and psychosocial changes during pregnancy, and seeking support from healthcare professionals. The education will be delivered face-to-face by the researcher in two sessions, with a one-week interval between sessions.
Eligible pregnant women with hypertensive disorders will be randomly assigned to either an intervention group or a control group. The intervention group will receive Roy Adaptation Model-based prenatal education, while the control group will receive routine antenatal care. A blood pressure monitoring chart will be provided to participants in both groups.
Participants' perceived stress levels and quality of life will be assessed at the measurement time points specified in the study protocol. Sociodemographic and obstetric characteristics will also be collected using a researcher-developed introductory information form. Participants in the intervention group will provide feedback regarding the education through an education satisfaction evaluation form.
The primary aim of this study is to evaluate the effect of Roy Adaptation Model-based prenatal education on perceived stress and quality of life in pregnant women with hypertensive disorders. The findings are expected to contribute to the development and implementation of theory-based prenatal education programs tailored to the needs of pregnant women with hypertensive disorders and to support evidence-based midwifery care.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Esra Erdem, midwife
- Número de teléfono: +90 537 011 59 36
- Correo electrónico: esra.erdem@ogr.iuc.edu.tr
Ubicaciones de estudio
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Istanbul, Turquía (Türkiye), 34384
- Prof. Dr. Cemil Taşcıoğlu Şehir Hastanesi
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Contacto:
- Esra Erdem, midwife
- Número de teléfono: yok +90 537 011 59 36
- Correo electrónico: esra.erdem@ogr.iuc.edu.tr
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Investigador principal:
- Esra Erdem, Midwife
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Pregnant women who apply to the antenatal outpatient clinic of the relevant hospital.
- Women diagnosed by a physician with a hypertensive disorder of pregnancy. Women who are between 20 and 32 weeks of gestation.
- Women aged 18 years or older.
- Primiparous or multiparous pregnant women.
- Women who can read and understand Turkish and communicate in Turkish.
- Women who are willing to participate in the study.
Exclusion Criteria:
- Pregnant women with severe preeclampsia, eclampsia, HELLP syndrome, or a clinical condition requiring emergency obstetric intervention.
- Pregnant women who are hospitalized or scheduled for hospitalization at the beginning of the study.
- Pregnant women diagnosed with fetal anomaly or intrauterine fetal death.
- Pregnant women with severe psychiatric, neurological, or cognitive impairment that may prevent participation in the education sessions or completion of the data collection instruments.
- Pregnant women who develop a serious obstetric or clinical complication during the study that may affect the primary outcomes of the study.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- 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
Participants assigned to the intervention group will first be informed about the study and provide written informed consent.
They will then complete the Introductory Information Form and the pre-intervention assessments of perceived stress and quality of life.
Subsequently, they will receive Roy Adaptation Model-based prenatal education in two face-to-face sessions, one week apart.
Each session will last approximately 45 minutes.
The education will address hypertensive disorders of pregnancy, blood pressure monitoring, healthy lifestyle behaviors during pregnancy, stress management, adaptation to physical and psychosocial changes during pregnancy, and seeking support from healthcare professionals.
Participants will also be provided with a blood pressure monitoring chart.
Following the education, post-intervention assessments of perceived stress and quality of life will be conducted.
Finally, participants will complete the Education Satisfaction Evaluation Form.
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Roy Adaptation Model-based prenatal education will be provided face-to-face by the researcher to pregnant women with hypertensive disorders of pregnancy.
The education will be delivered in two sessions, one week apart, with each session lasting approximately 45 minutes.
The educational content will address hypertensive disorders of pregnancy, blood pressure monitoring, healthy lifestyle behaviors during pregnancy, stress management, adaptation to physical and psychosocial changes during pregnancy, and seeking support from healthcare professionals.
Participants will also receive a blood pressure monitoring chart for home monitoring.
The intervention is specifically structured according to the four adaptive modes of the Roy Adaptation Model: physiological-physical, self-concept, role function, and interdependence.
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Sin intervención: Control Group
Participants assigned to the control group will first be informed about the study and provide written informed consent.
They will then complete the Introductory Information Form and the pre-intervention assessments of perceived stress and quality of life.
Participants will continue to receive routine antenatal care throughout the study.
They will also be provided with a blood pressure monitoring chart and instructed on blood pressure monitoring.
No Roy Adaptation Model-based prenatal education will be provided to the control group during the study.
At the end of the study follow-up period, the post-intervention assessments of perceived stress and quality of life will be conducted.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Perceived Stress Level in High-Risk Pregnancies
Periodo de tiempo: At baseline (before the first education session) and 2 weeks after baseline
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Perceived stress level will be assessed using the High-Risk Pregnancy Perceived Stress Scale.
Higher scores indicate higher perceived stress.
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At baseline (before the first education session) and 2 weeks after baseline
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Pregnancy-Related Quality of Life Score
Periodo de tiempo: At baseline (before the first education session) and 2 weeks after baseline
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Quality of life will be assessed using the Pregnancy Quality of Life Scale.
Higher scores indicate better quality of life.
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At baseline (before the first education session) and 2 weeks after baseline
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Director de estudio: Sevda Korkut Öksüz, Istanbul University - Cerrahpasa
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
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
- IUC-EBELİK-EE-01
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
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