- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07596368
THE EFFECT OF MOTIVATIONAL INTERVIEWING ON MENOPAUSE MYTHS AND POSTTRAUMATIC GROWTH IN POSTMENOPAUSAL WOMEN:RANDOMIZED CONTROLLED STUDY
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Menopause is a biological transition that may affect women physically, psychologically, and socially. Misconceptions regarding menopause may negatively influence adaptation to this period, while positive coping may support posttraumatic growth.
Motivational interviewing is a client-centered counseling approach designed to strengthen intrinsic motivation and promote positive behavioral change. This randomized controlled trial aims to determine the effect of motivational interviewing on menopause myths and posttraumatic growth in postmenopausal women.
The study will be conducted in Family Health Centers in Gaziantep, Turkey, with 96 postmenopausal women randomly assigned to intervention and control groups. The intervention group will receive four weekly face-to-face motivational interviewing sessions lasting 30-45 minutes. The control group will receive usual care without intervention.
Data will be collected at baseline and after intervention using the Menopause Myths Scale and the Posttraumatic Growth Scale.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Women who have had their last menstrual period between 12 and 36 months ago,
- are literate,
- can read and write in Turkish,
- do not have any problems that may hinder communication, and
- do not have any diagnosed psychiatric illness will be included in the study.
Exclusion Criteria:
- Those receiving HRT treatment,
- Those whose last menstrual period was 36 months or more ago,
- Women receiving oncology treatment.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Sin intervención: grupo de control
Sin intervención
|
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Experimental: intervention group
The researcher provided training on motivational interviewing techniques to be applied to the experimental group prior to the intervention.
Women were informed about the research, and those wishing to participate were given a voluntary information form to read, and their verbal and written consent was obtained.
Before starting the Motivational Interview sessions, the client was informed about the duration, number, and timing of the sessions.
Each motivational interview session with the women in the experimental group is planned to last approximately 30-45 minutes.
A total of four motivational interview sessions will be conducted with the women in the experimental group, once a week.
All sessions will be conducted by inviting the women to their family physician's office.
During the motivational interview sessions, counseling will be provided on topics related to the menopausal period, aiming to change negative beliefs about menopause myths and increase post-traumatic growth levels.
|
The researcher provided training on motivational interviewing techniques to be applied to the experimental group prior to the intervention.
Women will be informed about the research, and those wishing to participate will be given a voluntary information form to read, and their verbal and written consent will be obtained.
The client will be informed about the duration, number, and timing of the interviews before the start of the MG sessions.
Each motivational interview session with the women in the experimental group is planned to last approximately 30-45 minutes.
A total of four MG sessions will be conducted with the women in the experimental group, once a week.
All sessions will be conducted by inviting the women to their family physician's office.
During the MG sessions, counseling will be provided on topics related to the menopausal period in order to change the women's negative beliefs about menopause myths and to increase their post-traumatic growth levels after menopause.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
MENOPAUSE MYTHS SCALE
Periodo de tiempo: At the beginning and at the end of the 4-week intervention period
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Women's perceptions of menopause were measured using the Menopause Myths Scale.
|
At the beginning and at the end of the 4-week intervention period
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Post-Traumatic Growth Scale
Periodo de tiempo: At the beginning and at the end of the 4-week intervention period
|
The Post-Traumatic Growth Scale was used to assess the extent to which menopause creates trauma in women's lives.
|
At the beginning and at the end of the 4-week intervention period
|
Colaboradores e Investigadores
Patrocinador
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
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 860686
Información sobre medicamentos y dispositivos, documentos del estudio
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