- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07593326
Midwife-Led Antenatal Perineal Massage Education in Primiparous Pregnant Women (APM-EDU)
The Effect of Midwife-Led Antenatal Perineal Massage Education on Pregnancy Empowerment, Self-Efficacy for Normal Birth, and Fear of Childbirth
This study aims to evaluate the effect of midwife-led antenatal perineal massage education on pregnancy empowerment, self-efficacy for normal birth, and fear of childbirth among primiparous pregnant women. The study is designed as a controlled quasi-experimental study and will be conducted at the Obstetrics and Gynecology Outpatient Clinic of Silifke State Hospital in Mersin, Turkey.
Eligible participants will be primiparous pregnant women aged 18-35 years, between 28 and 34 weeks of gestation, with a singleton pregnancy and a plan for vaginal birth. Participants in the intervention group will receive structured antenatal perineal massage education led by a midwife, in addition to routine antenatal care. Participants in the control group will receive routine antenatal care.
The primary outcome will be pregnancy empowerment. Secondary outcomes will include self-efficacy for normal birth, fear of childbirth, knowledge and preferences regarding antenatal perineal massage, and adherence to antenatal perineal massage practice.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
This controlled quasi-experimental study will evaluate the effect of a structured midwife-led antenatal perineal massage education program on pregnancy empowerment, self-efficacy for normal birth, and fear of childbirth among primiparous pregnant women. The study will be conducted at the Obstetrics and Gynecology Outpatient Clinic of Silifke State Hospital in Mersin, Turkey, after ethics committee approval.
The study population will consist of pregnant women attending the Obstetrics and Gynecology Outpatient Clinic of Silifke State Hospital. Eligible participants will be women aged 18-35 years who are at least primary school graduates, able to communicate in Turkish, between 28 and 34 weeks of gestation, primiparous, carrying a singleton pregnancy, planning a vaginal birth, able to use a smartphone, and have internet access. Women with an indication for planned cesarean section, a history of perineal surgery, an active genital infection or lesion, or cognitive, communication-related, or psychiatric conditions that prevent completion of study forms will be excluded.
The planned sample size is 152 pregnant women, with 76 participants in the intervention group and 76 participants in the control group. The sample size was calculated using G*Power version 3.1.9.7 based on a two-tailed test, a significance level of 0.05, statistical power of 80%, and an assumed medium effect size of Cohen's d = 0.50. The minimum required sample size was calculated as 64 participants per group, and the target sample size was increased to 76 participants per group to account for potential attrition or missing data.
Participants in the intervention group will receive structured midwife-led antenatal perineal massage education in addition to routine antenatal care. The educational content will include the importance of pelvic health, preparation for antenatal perineal massage, antenatal perineal massage technique, and maintenance of pelvic health. The intervention is intended to improve women's knowledge and practice of antenatal perineal massage and to support empowerment, confidence regarding normal birth, and reduction of fear related to childbirth. Participants in the control group will receive routine antenatal care provided at the study hospital.
Data will be collected using a Participant Information Form, the Antenatal Perineal Massage Knowledge and Preference Form, the Pregnancy Empowerment Scale, the Self-Efficacy Scale for Normal Birth, the Childbirth Attitudes Scale, and the Antenatal Perineal Massage Follow-up Form. The primary outcome will be change in pregnancy empowerment. Secondary outcomes will include change in self-efficacy for normal birth, change in fear of childbirth, antenatal perineal massage knowledge and preferences, and adherence to antenatal perineal massage practice.
Baseline data will be collected before the intervention. Post-intervention data will be collected after completion of the antenatal perineal massage education and follow-up period, according to the study protocol. The study is planned to be conducted between May 15, 2026 and December 31, 2026.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Sümeyra Dilek Soydan, Master's degree student
- Número de teléfono: +90 212 761 87 +905533187543
- Correo electrónico: soydansumeyradilek@gmail.com
Ubicaciones de estudio
-
-
Silifke
-
Mersin, Silifke, Turquía (Türkiye), 33960
- Silifke State Hospital, Obstetrics and Gynecology Outpatient Clinic
-
Contacto:
- Sümeyra Dilek Soydan, Master's degree
- Número de teléfono: +90 212 761 87 05533187543
- Correo electrónico: soydansumeyradilek@gmail.com
-
Investigador principal:
- Sümeyra Dilek Soydan, Master's degree
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Women aged 18 to 35 years
- At least primary school graduates
- Able to communicate in Turkish
- Between 28 and 34 weeks of gestation
- Primiparous pregnant women
- Singleton pregnancy
- Planning vaginal birth
- Able to use a smartphone
- Having internet access
- Willing to participate in the study and providing informed consent
Exclusion Criteria:
- Having an indication for planned cesarean section
- History of perineal surgery
- Presence of active genital infection or genital lesion
- Cognitive, communication-related, or psychiatric condition that may prevent completion of the study forms
- Refusal to participate in the study
- Withdrawal from the study during the study process
- Failure to complete the educational intervention
- Missing pre-test or post-test data
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Sin intervención: Control Group
Participants in the control group will receive routine antenatal care provided at the study hospital.
Data from the control group will be collected before the intervention group to minimize contamination and reduce the possibility of access to the educational intervention.
|
|
|
Experimental: APM Education Group
Participants in the intervention group will receive structured midwife-led antenatal perineal massage education in addition to routine antenatal care.
The intervention will be implemented after completion of control group data collection to minimize contamination between groups.
|
The intervention is a structured midwife-led antenatal perineal massage education program delivered to primiparous pregnant women in the third trimester.
The educational content includes the importance of pelvic health, preparation for antenatal perineal massage, antenatal perineal massage technique, and maintenance of pelvic health.
The program is designed to improve knowledge and practice regarding antenatal perineal massage and to support pregnancy empowerment, self-efficacy for normal birth, and reduction of fear of childbirth.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in Pregnancy Empowerment
Periodo de tiempo: Baseline and 4 weeks after completion of the education program
|
Pregnancy empowerment will be assessed using the Pregnancy Empowerment Scale.
The outcome will be evaluated by comparing scores between baseline and post-intervention assessment.
Higher scores indicate higher pregnancy empowerment.
|
Baseline and 4 weeks after completion of the education program
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in Self-Efficacy for Normal Birth
Periodo de tiempo: Baseline and 4 weeks after completion of the education program
|
Self-efficacy for normal birth will be assessed using the Self-Efficacy Scale for Normal Birth.
The scale will be administered at baseline and 4 weeks after completion of the education program.
Change in self-efficacy for normal birth will be evaluated by comparing baseline and post-test scores.
Higher scores indicate higher perceived self-efficacy for normal birth.
|
Baseline and 4 weeks after completion of the education program
|
|
Change in Fear of Childbirth
Periodo de tiempo: Baseline and 4 weeks after completion of the education program
|
Fear of childbirth will be assessed using the Childbirth Attitudes Scale.
The scale will be administered at baseline and 4 weeks after completion of the education program.
Change in fear of childbirth will be evaluated by comparing baseline and post-test scores.
|
Baseline and 4 weeks after completion of the education program
|
Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Immediate Change in Antenatal Perineal Massage Knowledge
Periodo de tiempo: Baseline and immediately after completion of the education program
|
Antenatal perineal massage knowledge will be assessed using the Antenatal Perineal Massage Knowledge and Preference Form developed for this study.
The form will be administered at baseline and immediately after completion of the education program.
Immediate change in knowledge will be evaluated by comparing baseline and immediate post-intervention scores.
Higher scores indicate higher knowledge regarding antenatal perineal massage.
|
Baseline and immediately after completion of the education program
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Silla de estudio: Filiz Okumuş, Assoc. Prof. Dr., Atlas University
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
Otros números de identificación del estudio
- APM-EDU-SILIFKE-2026-001
- E-22686390-050.99-96214 (Otro identificador: Istanbul Atlas University Non-Interventional Scientific Research Ethics Committee)
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
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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. .