- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07544511
Efecto de la estimulación mediante masaje manual sobre el dolor y los síntomas menstruales en la dismenorrea primaria
Efecto de la estimulación del masaje de manos sobre el dolor y los síntomas menstruales en la dismenorrea primaria
Purpose of this study: The purpose of this study is to determine the effect of hand massage stimulation techniques on pain, daily menstrual symptoms and nausea and vomiting in primary dysmenorrhea.
H1a: Hand massage stimulation techniques reduce pain in primary dysmenorrhea. H1b: Hand massage stimulation techniques reduce daily menstrual symptoms in primary dysmenorrhea.
The data were collected from students suffering from primary dysmenorrhea pain studying at İnönü University Faculty of Health Sciences. Seed therapy (su-jok) will be applied by researcher Melike TAN ÇELİK who has a basic level su-jok therapy certificate.
Descripción general del estudio
Descripción detallada
The aim of this study is to determine the effect of hand massage stimulation techniques on pain, daily menstrual symptoms and nausea and vomiting in primary dysmenorrhea.
Data will be collected from students experiencing Primary Dysmenorrhea at İnönü University Faculty of Health Sciences. Participants who meet the inclusion criteria and agree to participate will be informed about the study, and participants who fill out the "Minimum Informed Consent Form" will be included in the study. Data collection forms will be applied by the researcher, paying attention to student privacy, and the pre-test data collection phase will be completed. After the pre-test data collection phase is completed, hand stimulation techniques (su-jok seed therapy) will be applied by the researcher to the students experiencing primary dysmenorrhea in the experimental group. Students experiencing primary dysmenorrhea will be given detailed information about the application in the laboratory at the faculty, and pain points will be determined according to the reflections of the organs on the hand. Black pepper seeds, one of the seeds used in the treatment of primary dysmenorrhea, will be placed on the detected points and removed after 5-6 hours. This application will be done a total of 3 times in each cycle, on the 1st, 2nd and 3rd day of the menstrual cycle. A total of 2 cycles of application will be made, the first menstrual cycle being the 1st cycle, and the final test data will be collected 5-6 hours after each application. This intervention will be carried out by Melike Tan, and the researcher has a basic level Su Jok therapy certificate. No intervention will be applied to the students experiencing primary dysmenorrhea in the control group, but the Personal Information Form, Visual Analog Scale (VAS), and Daily Menstrual Symptom Assessment Scale (GMDSS) will be administered simultaneously to the experimental group.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Malatya, Turquía (Türkiye)
- İnönü University Faculty of Health Sciences
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Participant who is 18 years or older
- Participant diagnosed with primary dysmenorrhea by a gynecologist
- Participant who has had regular menstruation in the last 6 months
- Participant whose menstrual pain continues for 8-72 hours
Exclusion Criteria:
- Participant who is pregnant
- Participant who has given birth before or has a history of pregnancy
- Participant using intrauterine or oral contraceptives
- Participant who is taking any anti-inflammatory, analgesic and psychotherapeutic medication
- Participant with any history of pelvic pathology or pelvic surgery
- Participant with any neurological or systemic disease
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: seed therapy ( su-jok)
Group that received seed therapy ( su- jok ) |
In hand massage, tiny swellings called "ball conformity" occur on the reflection points of the organs where the complaint occurs on the hands and feet. It is argued that the sensitivity of the relevant point to pressure has a direct correlation with the level of pain in the body part. A rod called a "diagnostic probe" or "diagnostic rod" made of metal, plastic or wood, approximately ten centimeters long, is used to detect the painful point on the hand and foot. After the correct point is detected, various techniques are applied to stimulate these points and ensure the continuation of the energy flow.In this study, the seed massage technique, which does not cause any side effects among the hand massage stimulation methods, requires a basic level certificate for its use, does not require being a health professional, and can be easily applied by anyone, will be used. Seed massage is a method applied by first detecting pain through a probe on the points of the organs reflected on the hand |
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Sin intervención: standard maintenance
group not receiving seed therapy ( su- jok) |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Visual Analog Scale (VAS)
Periodo de tiempo: At baseline (pre-intervention) and immediately after completion of seed therapy]
|
Description: VAS is a scale created in the range of 0-10 cm. According to the scale, 0 cm means the pain is not severe at all, and 10 cm means unbearable pain. On the scale, 0-44 mm indicates mild pain, 45-74 mm indicates moderate pain, and 75-100 mm indicates severe pain. Time Frame: At baseline (pre-intervention) and immediately after completion of seed therapy. |
At baseline (pre-intervention) and immediately after completion of seed therapy]
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Daily Menstrual Symptom Assessment Scale (DMSA)
Periodo de tiempo: At baseline (pre-intervention) and immediately after completion of seed therapy]
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The GMMSS was developed by Taylor in 1979 to assess symptoms and their severity during menstruation. The Turkish validity and reliability of the scale were established by Oskay et al. in 2008. The scale consists of seventeen items, with each symptom severity scored between 0 and 5, and there are no subscales. An increase in the score indicates an increase in symptom severity. In Oskay et al.'s study, the Cronbach's alpha value of the scale was found to be 0.88. [Time Frame: Initially (before intervention) and immediately after completion of insemination treatment] |
At baseline (pre-intervention) and immediately after completion of seed therapy]
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Esra GÜNEY, PhD, Inonu University
Publicaciones y enlaces útiles
Enlaces Útiles
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
- 7879
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Research results will be shared
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.
producto fabricado y exportado desde los EE. UU.
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