Esta página se tradujo automáticamente y no se garantiza la precisión de la traducción. por favor refiérase a versión inglesa para un texto fuente.

Nulliparous Women and Education and Counseling

2 de febrero de 2022 actualizado por: Sümeyye BAL, Ondokuz Mayıs University

The Effect of Education and Counseling on Reducing Anxiety and Depression in Nullipar Pregnancy Women

This study investigates the effect of education and counseling on anxiety and depression in nullipar women.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

Pregnancy is a special process in a woman's life in which physiological, social and psychological changes occur. In this process, most women experience anxiety and depression, which are an important global health problem.The fear of uncertainty experienced by women who will become mothers for the first time may cause them to experience more anxiety/depression. The aim of this study was to investigate the effect of education and counseling on anxiety and depression of women.

This randomized controlled study was conducted at state hospital in northern Turkey , Obstetrics and Gynecology polyclinic between January 2022 and March 2022. Volunteer women undergoing polyclinic have been included. Participants were randomly assigned to the intervention or the control group using a computer-generated list. A data collection form including socio-demographic and obstetric characteristics such as age, educational status, Hospital Anxiety Depression Scale (HADS) was used for each patient. After obtaining written informed consent, the data collection form, Hospital Anxiety Depression Scale (HADS) were applied to both groups by face to face interview. Immediately after the questionnaires were applied, the nurse gave individual education and counseling were giving by the nurse researcher to intervention group for 30 minutes. Participants in the control group received standard care (verbal information about procedure and a short written information about the procedure) and no intervention (education and counseling) was performed.The IBM SPSS (Statistical package for the Social Sciences) 23.0 package program was used to evaluate the data obtained in the study.

Tipo de estudio

Intervencionista

Inscripción (Actual)

100

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.

Ubicaciones de estudio

    • Atakum
      • Samsun, Atakum, Pavo, 55200
        • Ondokuz Mayis University

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

18 años a 50 años (Adulto)

Acepta Voluntarios Saludables

Géneros elegibles para el estudio

Femenino

Descripción

Inclusion Criteria:

  • A healthy pregnant woman over 18 years of age,
  • without a diagnosed psychiatric disease,
  • without mental disability and communication problems,
  • at 28 weeks of gestation,
  • nulliparous,
  • without fetal anomaly,
  • without risky pregnancy

Exclusion Criteria:

  • A healthy pregnant woman under 18 years of age,
  • with a diagnosed psychiatric disease,
  • with mental disability and communication problems,
  • under 28 weeks of gestation,
  • multiparous,
  • with fetal anomaly,
  • with risky pregnancy

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: Prevención
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Education and Counseling

After obtaining written informed consent, the data collection form, Hospital Anxiety Depression Scale (HADS) was applied to both groups by face to face interview. Immediately after the questionnaires were applied, the nurse gave individual education and counseling were giving by the nurse researcher to intervention group for 30 minutes. Women were counseled for 6 weeks.

Anxiety-depression levels (post-test) were applied by phone call 6 weeks later.This education consisted of the definition and the purpose of pregnancy and pregnancy problems and nutrition during pregnancy, sexuality during pregnancy, number of fetal movements, preparation of the delivery bag, breast care, etc.

After obtaining informed consent, the data collection form, Hospital Anxiety Depression Scale (HADS) was applied to both groups by face to face interview. Immediately after the questionnaires were answered, individual education and counseling were giving by the nurse researcher to intervention group for 30 minutes. In addition, the education and counseling given to the participants by the researcher.The experimental group was given a telephone number where they could receive consultancy services for 12 hours a day. Pre-test was applied. One day later, the pregnant woman was called and encouraged to call for all her questions, and she was informed that she would be returned when she called.
Sin intervención: control group
Participants in the control group received standard care (verbal information about procedure and a short written information about the procedure) and no intervention (education and counseling) was performed.The control group was called by phone at the end of 6 weeks and told that they would be retested and 6 weeks later, they were called by phone and their anxiety and depression levels (posttest) were applied. directed to continue

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Hospital Anxiety Depression Scale (HADS)
Periodo de tiempo: 30 minutes
The HADS contains 14 items and consists of two subscales: anxiety and depression. Each item is rated on a four-point scale, giving maximum scores of 21 for anxiety and depression. Scores of 11 or more on either subscale are considered to be a significant 'case' of psychological morbidity, while scores of 8-10 represents 'borderline' and 0-7 'normal' (Zigmont ve Snaith).
30 minutes

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Investigadores

  • Investigador principal: Emine KOÇ, Asst.Prof, Ondokuz Mayıs University
  • Silla de estudio: Nazlı BALTACI, Asst.Prof, Ondokuz Mayıs University

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.

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 (Actual)

25 de enero de 2021

Finalización primaria (Actual)

1 de enero de 2022

Finalización del estudio (Actual)

5 de enero de 2022

Fechas de registro del estudio

Enviado por primera vez

17 de enero de 2022

Primero enviado que cumplió con los criterios de control de calidad

17 de enero de 2022

Publicado por primera vez (Actual)

31 de enero de 2022

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

3 de febrero de 2022

Última actualización enviada que cumplió con los criterios de control de calidad

2 de febrero de 2022

Última verificación

1 de febrero de 2022

Más información

Términos relacionados con este estudio

Palabras clave

Otros números de identificación del estudio

  • 2020/737

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

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 Education and counseling

3
Suscribir