- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00857051
Postpartum Support: Can we Facilitate the Transition to Motherhood?
Descripción general del estudio
Descripción detallada
The postpartum period is a very stressful experience for most mothers. It is generally accepted that women are physically and psychologically stressed during the postpartum. After delivery a woman may have worries about the health of her baby and her own health, as well as the changes in her body, their impact on her sexual life and her relationship with her husband. In addition, she may have financial concerns, concerns about breastfeeding, and be worried about bonding with her baby.
First-time mothers also have to adapt to their new role as mothers and may be worried about their abilities to take care of the baby. This may cause first-time mothers to develop postpartum depression and other emotional problems. First-time mothers can feel overwhelmed, exhausted, and isolated in their new roles.
We are conducting a study to look interventions that may reduce stress in the postpartum period for first- time mothers. One of these interventions is an educational film that describes the common stressors that first-time parents go through in the early postpartum period. The other is a hotline service that women can call at anytime during the first 3 months postpartum to ask about problems she or the baby may be experiencing. The hotline will be answered by a trained midwife.
Women will be recruited from all hospitals in Beirut after delivery and before they leave the hospital. If they agree to participate in the study, they will be randomly assigned to receive the film, the hotline service, both the film and the hotline service, or a CD containing children's songs. Women will be visited at home at 2 - 3 months after delivery by a researcher to complete questionnaires designed to measure stress, depression and anxiety in the postpartum.
Participants will not receive any financial compensation for participating in the study. Although women may benefit from the interventions, we will not know that until we complete the study. However, participation in this study may benefit mothers in the future if we find that the hotline or educational video are useful. There are no risks associated with participation in this study.
Confidentiality of the collected information will be ensured. All information collected will be used for research purposes and will be kept anonymous.
Tipo de estudio
Inscripción (Anticipado)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
-
Beirut, Líbano
- American University of Beirut
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Healthy first-time mothers with singleton baby delivered at term with no complications.
Exclusion Criteria:
- Mothers with chronic health problems,
- Pregnancy complications, OR
- Infants with congenital problems or conditions requiring admission to the intensive care nursery.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: 1
A 22 minute DVD that discusses common stressor in the early postpartum.
|
A DVD addressing common stressors in the early postpartum.
|
Experimental: 2
A 24 hour hotline available for the first 3 months postpartum.
|
A 24 hour hotline to answer questions about baby care or mother self-care.
Hotline will be answered by a midwife and answers will be based on algorithms.
|
Experimental: 3
Both the film and the hotline will be given to this arm.
|
A DVD addressing common stressors in the early postpartum.
A 24 hour hotline to answer questions about baby care or mother self-care.
Hotline will be answered by a midwife and answers will be based on algorithms.
|
Sin intervención: 4
A CD of children's music will be given to mothers in this arm.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
---|---|
Stress as measure by the Cohen Perceived Stress Scale (PSS-10)
Periodo de tiempo: 2 - 3 months
|
2 - 3 months
|
Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
---|---|
Depression
Periodo de tiempo: 2 - 3 months
|
2 - 3 months
|
Anxiety
Periodo de tiempo: 2 - 3 months
|
2 - 3 months
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Hibah Osman, MD, MPH, American University of Beirut Medical Center
Publicaciones y enlaces útiles
Publicaciones Generales
- Osman H, Saliba M, Chaaya M, Naasan G. Interventions to reduce postpartum stress in first-time mothers: a randomized-controlled trial. BMC Womens Health. 2014 Oct 15;14:125. doi: 10.1186/1472-6874-14-125.
- Hamade H, Chaaya M, Saliba M, Chaaban R, Osman H. Determinants of exclusive breastfeeding in an urban population of primiparas in Lebanon: a cross-sectional study. BMC Public Health. 2013 Jul 31;13:702. doi: 10.1186/1471-2458-13-702.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- FM.HO.04
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. .
Ensayos clínicos sobre Film
-
Allegheny Singer Research Institute (also known...TerminadoCáncer de mama | Efecto secundario de la radioterapia | Dermatitis por radiación | Radioterapia; Complicaciones | Radioterapia; Efecto Adverso, Dermatitis o Eczema | Quemadura por radiaciónEstados Unidos
-
Andrew MeltzerBioFire Diagnostics, LLCTerminado
-
BioMérieuxBioFortis; APHPDesconocidoInfecciones del Tracto RespiratorioFrancia
-
Universidade Estadual Paulista Júlio de Mesquita...ReclutamientoCicatrización de la herida | Paladar; HeridaBrasil
-
Shiraz University of Medical SciencesShiraz education development centerTerminadoEnseñanza de RCPIrán (República Islámica de
-
Universidade Estadual Paulista Júlio de Mesquita...ReclutamientoInsulina | Cicatrización de la herida | Paladar; HeridaBrasil
-
Fondazione Policlinico Universitario Agostino Gemelli...Catholic University of the Sacred HeartReclutamientoVAP - Neumonía asociada al ventilador | HAP - Neumonía Adquirida en el HospitalItalia
-
University of MiamiTerminadoGlaucoma | Presión intraocular | AnestesiaEstados Unidos
-
BioDelivery Sciences InternationalTerminadoOsteoartritis | Lumbalgia | Dolor neuropáticoEstados Unidos
-
Health Institutes of TurkeyTerminado