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The Psychosocial Effects of Prenatal Education With the Indivisible Self Model

11 de julio de 2026 actualizado por: Gozde Gokce Isbir, Mersin University

The Impact of a Prenatal Education Program Based on the Indivisible Self Model on Psychosocial Outcomes: A Randomized Controlled Study

This study was designed to compare the effects of a prenatal education program based on the Indivisible Self Model with those of a needs-based prenatal education program on psychosocial outcomes among pregnant women.

Descripción general del estudio

Estado

Aún no reclutando

Condiciones

Intervención / Tratamiento

Descripción detallada

This study is designed as a single-blind randomized controlled trial to compare the effects of an Indivisible Self Model-based prenatal education program with those of a needs-based prenatal education program on psychosocial outcomes among pregnant women residing in Aksaray, Türkiye, between December 2025 and November 2026. Eligible pregnant women who meet the inclusion criteria will be informed about the study objectives and procedures, and written informed consent will be obtained prior to participation. Participants will be randomly allocated to one of two intervention groups. The intervention group will receive a prenatal education program based on the Indivisible Self Model. Training will be delivered by a researcher-midwife in face-to-face group sessions consisting of 7-8 participants, with a total of five groups. The program will comprise 10 sessions delivered over two consecutive days, with five 45-minute sessions scheduled each day and a 15-minute break between sessions. The curriculum will be structured around the five dimensions of the Indivisible Self Model (Creative Self, Coping Self, Social Self, Essential Self, and Physical Self). Each dimension will include an interactive theoretical component followed by practical activities designed to enhance participants' knowledge, skills, and psychosocial well-being. The control group will receive a needs-based prenatal education program developed according to participants' identified educational needs and the Turkish Ministry of Health's Standard Training Content for Pregnant Information Classes. Training will likewise be delivered face-to-face by the researcher-midwife to groups of 7-8 participants, with five groups in total. The program will consist of 10 sessions conducted over two consecutive days, following the same schedule as the intervention group. The curriculum will focus on pregnancy, childbirth, breastfeeding, postpartum care, and newborn care, aiming to improve participants' knowledge and practical skills. Educational sessions will incorporate interactive teaching strategies, including open-ended questioning, reflective listening, affirmations, and communication techniques appropriate to the learning objectives. Delivery of both educational programs is expected to be completed within a 10-week period. Outcome measures and study questionnaires will be administered in person at three time points: baseline (before the first training session), immediately after completion of the education program, and during the early postpartum period (12-24 hours after birth). The study protocol has been developed and will be conducted in accordance with the CONSORT guidelines.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

76

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

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

Acepta Voluntarios Saludables

Sí

Descripción

Inclusion Criteria:

  • Between December 2025 and November 2026,
  • Living in the province of Aksaray,
  • Female,
  • Between the ages of 18-40,
  • Native language Turkish,
  • Between the 28th-32nd weeks of pregnancy,
  • In their first pregnancy,
  • With a singleton pregnancy,
  • Without any chronic disease or pregnancy complications,
  • Without any diagnosed active psychiatric disorder,
  • Having a mobile phone through which communication can be maintained,
  • Not having participated in another childbirth preparation program,
  • Not having participated in a prenatal psychoeducation and counseling program,
  • Planning the mode of delivery as vaginal birth , women will be included in the sample.

Exclusion Criteria:

Between December 2025 and November 2026,

  • Those whose native language is not Turkish,
  • Those who are male,
  • Those under 18 years of age or over 40,
  • Those whose pregnancy is less than 28 weeks or more than 32 weeks,
  • Those who have previously ended a pregnancy beyond 20 weeks with childbirth,
  • Those who are multiparous,
  • Those with multiple pregnancies,
  • Those with any chronic illness,
  • Those who experience any complication related to the mother or fetus/newborn during the research process,
  • Those who need to undergo a cesarean section at any stage of pregnancy or childbirth,
  • Those who develop mental health deviations during the research process and require professional support,
  • Those who did not attend 80% of the training,
  • Those who cannot be reached during the data collection process,
  • Women who wish to withdraw from the study at any stage of the research will be excluded from the study.

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: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Prenatal Education Program Based on the Indivisible Self Model
Interviews will be conducted with pregnant women visiting the hospital's midwifery clinic, and they will be informed about the study. Women who agree to participate and meet the inclusion criteria will be informed about the research, and a WhatsApp group will be created for those who wish to participate, and planning will be done. All sessions will be conducted in groups and face-to-face with the women. The sessions will be prepared according to the components of the Indivisible Self Model (Primary Self, Coping Self, Social Self, Creative Self, Physical Self), and for each component, one interactive theoretical presentation session and one practical application session will be planned. The training program will consist of 10 sessions in total, spread over 2 days, with 5 sessions of 45 minutes each day, followed by a 15-minute break.
Otro: Prenatal Education Program Based on the Indivisible Self Model
The Indivisible Self Model-based prenatal education program consists of 10 face-to-face group sessions delivered over 2 days. The program is structured around the five components of the Indivisible Self Model (Primary Self, Coping Self, Social Self, Creative Self, and Physical Self) and includes an interactive theoretical presentation and a practical application session for each component. Each training day comprises five 45-minute sessions with a 15-minute break between sessions. The program is designed to promote psychosocial well-being and enhance coping skills among pregnant women.
Comparador de placebos: Needs-Based Prenatal Education Program
The needs-based prenatal education program will be prepared based on the content and implementation guidelines published by the Ministry of Health of the Republic of Turkey and updated in maternity schools from 2024 onwards. Participants will be structured into 5 groups of 7-8 people each, who apply to the antenatal clinic and voluntarily participate in the education program to be conducted at the antenatal school; face-to-face group sessions will be held with each group. The program consists of a total of 10 sessions over a two-day period.
Otro: The needs-based prenatal education program
The needs-based prenatal education program consists of 10 face-to-face group sessions delivered over 2 days. Developed according to the Republic of Türkiye Ministry of Health's antenatal education guidelines (updated from 2024 onward), the program is tailored to participants' educational needs and covers pregnancy, childbirth, breastfeeding, postpartum, and newborn care. Each day includes five 45-minute sessions with 15-minute breaks. The program is designed to improve participants' knowledge, skills, and preparedness for childbirth and the postpartum period.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Psychological Well-Being Scale
Periodo de tiempo: Baseline: Within 24 hours before the education program. Post-intervention: Within 24 hours after completion of the education program. Postpartum follow-up: Within 12-24 hours after childbirth.

Participants' current levels of psychological well-being will be assessed using the "Psychological Well-Being Scale" developed by Diener et al. (2009-2010). This scale is a measurement tool developed to complement existing well-being measures and aims to assess individuals' socio-psychological well-being levels.

The scale has a 7-point Likert-type response format and consists of a total of 8 items, each rated from "1 = Strongly disagree" to "7 = Strongly agree". All items consist of positive statements, and the possible scores on the scale range from 8 to 56. Higher scores indicate a higher level of psychological well-being. The internal consistency of the scale was found to be α = .87 using Cronbach's alpha coefficient.
Baseline: Within 24 hours before the education program. Post-intervention: Within 24 hours after completion of the education program. Postpartum follow-up: Within 12-24 hours after childbirth.
Revised Emotional Consistency Scale
Periodo de tiempo: Baseline: Within 24 hours before the education program. Post-intervention: Within 24 hours after completion of the education program. Postpartum follow-up: Within 12-24 hours after childbirth.

Participants' levels of sense of coherence will be assessed using the Revised Emotional Coherence Scale, developed by Bachem and Maercker in 2016 to improve upon Antonovsky's original model.

Based on Antonovsky's "Sense of Coherence" theory, this scale aims to assess individuals' perceptions of their life experiences as meaningful, comprehensible, and manageable. The scale uses a five-point Likert-type response format, with items rated from "1 = Not true at all" to "5 = Very true". The minimum possible score is 13, and the maximum is 65. Higher scores indicate that individuals perceive their lives as more meaningful, comprehensible, and manageable, thus indicating a higher level of emotional coherence.

In the Turkish validity and reliability study of the scale, the Cronbach's alpha coefficient for overall internal consistency was determined as α = 0.82. The alpha values for the sub-dimensions are α = 0.77 for significance, α = 0.77 for compr
Baseline: Within 24 hours before the education program. Post-intervention: Within 24 hours after completion of the education program. Postpartum follow-up: Within 12-24 hours after childbirth.
Self-Efficacy Scale for Normal Birth
Periodo de tiempo: Baseline: Within 24 hours before the education program. Post-intervention: Within 24 hours after completion of the education program.

Participants' perceptions of control and support during childbirth will be assessed using the Perceived Control and Support During Childbirth Scale developed by Ford, Ayers, and Wright in 2009.

The Perceived Control and Support During Childbirth Scale is a scale developed to assess women's perceptions of control and support during childbirth in the postpartum period.The scale consists of three sub-dimensions: internal control, external control, and perceived support, and contains a total of 33 items. The PCS, which has a five-point Likert scale, is rated from "1 = Strongly disagree" to "5 = Strongly agree". The minimum possible score on the scale is 33, and the maximum score is 165. Higher scores indicate that the individual felt more control and perceived more support during childbirth.

In the Turkish reliability and validity study of the scale, the Cronbach's alpha coefficient was reported as 0.95.
Baseline: Within 24 hours before the education program. Post-intervention: Within 24 hours after completion of the education program.
Perceived Control and Support in Childbirth Scale
Periodo de tiempo: Postpartum follow-up: Within 12-24 hours after childbirth.

Participants' self-efficacy levels will be assessed using the Self-Efficacy Scale for Normal Delivery, developed by Chu et al. in 2017. This scale is an important assessment tool, particularly for determining women's attitudes towards normal delivery and their level of self-confidence during the prenatal period.

The scale consists of 9 items, each scored from 0 (no confidence at all) to 10 (very confident). Thus, the scale offers 11 different score options for each item. The total scores that can be obtained from the scale range from 0 to 90, with higher scores indicating a high level of self-efficacy belief in normal delivery. Cronbach's alpha coefficient was reported as 0.994 for the 2nd trimester; 0.956 for the 3rd trimester; and 0.980 for the entire scale. The Turkish adaptation, validity, and reliability study of the Self-Efficacy Scale for Normal Birth was carried out by Kahraman and Alparslan in 2022.
Postpartum follow-up: Within 12-24 hours after childbirth.

Colaboradores e Investigadores

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

Patrocinador

Mersin 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.

Publicaciones Generales

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)

15 de octubre de 2026

Finalización primaria (Estimado)

15 de noviembre de 2026

Finalización del estudio (Estimado)

15 de marzo 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

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • AKaras

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. .

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