- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07596459
Hybrıd Educatıon Based on Psychodynamıc Nursıng Theory of Women Undergoıng Mastectomy (Mastectomy)
The Effect of Hybrıd Educatıon Based on Psychodynamıc Nursıng Theory on Body Value, Socıal Appearance Anxıety and Sexual Qualıty of Lıfe of Women Undergoıng Mastectomy
Our study aims to investigate the effects of planned hybrid (web-based and face-to-face) group training to be given to women with mastectomies based on Psychodynamic nursing theory, on women's body value, social appearance anxiety and sexual life quality.
Power analysis was performed for the study group of the study and intervention and control groups were created by randomization method (intervention group n = 30, control group n = 30). The study will be applied as a pretest-posttest experimental intervention method. In order to make an evaluation before and after the planned hybrid training, the situations that are most affected by women after mastectomy were analyzed in line with the literature and the data were collected from the Sociodemographic Characteristics Form, Body Value Scale-2, Social Appearance Anxiety Scale (SAAS), Sexual Quality of Life Scale-Female (SQOL-W). will be collected using. A standard information brochure containing information about mastectomy will be given to the intervention and control groups after the pre-test. Then, hybrid group training based on Psychodynamic Nursing Theory will be given to the intervention group by the researcher. A Whatsapp group will also be established to enable patients to communicate and ask questions. During the process, 9 web-based and 3 face-to-face group trainings will be held. A posttest will be administered to both groups at the end of the last group training, and a permanence test will be administered 1 month later via Google surveys on the Whatsapp group. SPPS program and Pearson Chi-square test, Independent Samples Test, McNemar, Pearson Chi-square test, ANOVA (Repeated Measures ANOVA) will be used to analyze the data. As a result of the study, in line with the research findings, the effect of hybrid group training based on Psychodynamic Nursing Theory on the body value, social appearance anxiety and sexual life quality of women who have undergone mastectomy will be evaluated.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
Ortahisar
-
Trabzon, Ortahisar, Turquía (Türkiye), 61500
- Karadeniz Technıcal Unıversity
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Ages 18-55, no communication problems,
- Proficiency in Turkish,
- Internet access via mobile phone or computer,
- At least 6 months must have passed since mastectomy surgery (mourning period),
- Active sexual life,
- Agreement to participate in the study.
Exclusion Criteria:
- Having hearing, vision, or comprehension problems,
- Having undergone breast reconstruction,
- Receiving any psychiatric diagnosis during the research process,
- Participating in any training, research, or social activity group that may affect the outcome variables during the research process.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: initiative
First, preliminary test data was collected.
The researcher provided hybrid group training based on Psychodynamic Nursing Theory to the intervention group.
Throughout the process, 9 web-based and 3 in-person group training sessions were conducted.
A post-test was administered after the last group training session, and a retention test was administered one month later.
|
The intervention group received hybrid group education sessions based on Psychodynamic Nursing Theory.
A total of 12 sessions were conducted, including 9 web-based sessions and 3 face-to-face group sessions.
|
|
Sin intervención: control
First, preliminary test data was collected.
A standard information brochure was provided.
Simultaneously with the intervention group, a post-test and retention test were administered.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Body Value Scale Score
Periodo de tiempo: 12 weeks
|
Body esteem was assessed using the Body Esteem Scale (BES).
Scores were compared between intervention and control groups.
|
12 weeks
|
|
Social Appearance Anxiety Scale Score
Periodo de tiempo: 12 weeks
|
Social appearance anxiety was measured using the Social Appearance Anxiety Scale (SAAS).
Scores were compared between groups.
|
12 weeks
|
|
Sexual Quality of Life Scale Score
Periodo de tiempo: 12 weeks
|
Sexual quality of life was assessed using the Sexual Quality of Life-Female (SQOL-F) Scale.
Scores were compared between groups
|
12 weeks
|
Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
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 (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
- E-13562490-050.01.04-562578
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. .