Effect of Auricular Vagus Nerve Stimulation on Pain and Symptoms in Primary Dysmenorrhea
27 de junio de 2026 actualizado por: Hüsniye Merve Demirer, Istanbul Gelisim University
The Effect of Transcutaneous Auricular Vagus Nerve Stimulation on Pain, Menstrual Symptoms, Depression, and Anxiety in Young Adults With Primary Dysmenorrhea: A Randomized Single-Blind Controlled Trial
This study aims to investigate the effects of transcutaneous auricular vagus nerve stimulation (taVNS) on menstrual pain, pain threshold, depression, anxiety, menstrual symptoms, premenstrual syndrome, and functional and emotional impact of dysmenorrhea in young adult women with primary dysmenorrhea.
Descripción general del estudio
Estado
Terminado
Condiciones
Descripción detallada
Primary dysmenorrhea is a common condition affecting young women and is associated with significant physical and psychological symptoms. Non-invasive neuromodulation techniques such as transcutaneous auricular vagus nerve stimulation (taVNS) have gained attention as potential therapeutic approaches.
In this randomized controlled study, women diagnosed with primary dysmenorrhea will be randomly assigned to either an active taVNS group or a sham stimulation group. The intervention will be applied during the luteal phase between two consecutive menstrual cycles, totaling 10 sessions.
Outcome measures will include pain intensity, pain threshold, depression, anxiety, menstrual symptoms, premenstrual syndrome severity, and functional and emotional impact of dysmenorrhea.
Tipo de estudio
Intervencionista
Inscripción (Actual)
40
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.
Ubicaciones de estudio
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Avcılar
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Istanbul, Avcılar, Turquía (Türkiye)
- Istanbul Gelisim University
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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
No
Descripción
Inclusion Criteria:
- Female participants aged 18 years and older
- Diagnosed with primary dysmenorrhea (PD)
- Having regular menstrual cycles within the last 6 months
- Reporting menstrual pain intensity of at least 40 mm on the Visual Analog Scale (VAS)
- Willingness to participate in the study and providing informed consent
Exclusion Criteria:
- Diagnosis of secondary dysmenorrhea
- Irregular menstrual cycles
- Menstrual cycle length shorter than 21 days or longer than 35 days
- History of pregnancy or childbirth, or current pregnancy
- Use of intrauterine device (IUD) or oral contraceptives
- Current use of sedative, analgesic, anti-inflammatory, or psychotropic medication
- History of pelvic surgery or presence of pelvic pathology
- Presence of chronic, systemic, cardiovascular, or neurological diseases (e.g., diabetes mellitus, hypoglycemia, bradycardia, hypotension, hypotonic disorders, etc.)
- Presence of ear implants, ear wounds, or ear infections
- Presence of implanted electronic devices such as pacemakers
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: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Transcutaneous auricular vagus nerve stimulation (taVNS)
Transcutaneous auricular vagus nerve stimulation (taVNS) 10 sessions during luteal phase
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Participants in the experimental group received real transcutaneous auricular vagus nerve stimulation (taVNS).
The intervention was applied during the luteal phase between the first and second menstrual cycles.
A total of 10 sessions were administered.
Stimulation was delivered using a non-invasive device targeting the auricular branch of the vagus nerve.
Otros nombres:
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Comparador falso: Sham transcutaneous auricular vagus nerve stimulation
Sham transcutaneous auricular vagus nerve stimulation 10 sessions during luteal phase
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Participants in the control group received sham transcutaneous auricular vagus nerve stimulation (placebo stimulation).
The procedure mimicked the real stimulation protocol in terms of duration and application schedule but without delivering effective vagal nerve stimulation.
A total of 10 sessions were administered during the luteal phase between the first and second menstrual cycles.
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Menstrual pain intensity
Periodo de tiempo: Baseline (Cycle 1, Day 1 or Day 2 of menstruation). Cycle 2, Day 1 or Day 2 of menstruation (approximately one menstrual cycle [21-35 days] after baseline).
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Menstrual pain intensity is assessed using the Visual Analog Scale (VAS).
Scores range from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain.
Higher scores indicate greater pain intensity.
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Baseline (Cycle 1, Day 1 or Day 2 of menstruation). Cycle 2, Day 1 or Day 2 of menstruation (approximately one menstrual cycle [21-35 days] after baseline).
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Pain threshold
Periodo de tiempo: Baseline (Cycle 1, Day 1 or Day 2 of menstruation). Cycle 2, Day 1 or Day 2 of menstruation (approximately one menstrual cycle [21-35 days] after baseline).
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Pain threshold is assessed using a pressure algometer.
The pressure pain threshold is recorded in lb/cm².
Higher values indicate a higher pressure pain threshold and lower pain sensitivity.
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Baseline (Cycle 1, Day 1 or Day 2 of menstruation). Cycle 2, Day 1 or Day 2 of menstruation (approximately one menstrual cycle [21-35 days] after baseline).
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Depression level
Periodo de tiempo: Baseline (Cycle 1, Day 1 or Day 2 of menstruation). Cycle 2, Day 1 or Day 2 of menstruation (approximately one menstrual cycle [21-35 days] after baseline).
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Depression levels are assessed using the Beck Depression Inventory (BDI).
The BDI is a 21-item self-report questionnaire with total scores ranging from 0 to 63.
Higher scores indicate more severe depressive symptoms.
Scores of 0-9 indicate minimal, 10-16 mild, 17-29 moderate, and 30-63 severe depressive symptoms.
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Baseline (Cycle 1, Day 1 or Day 2 of menstruation). Cycle 2, Day 1 or Day 2 of menstruation (approximately one menstrual cycle [21-35 days] after baseline).
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Anxiety level
Periodo de tiempo: Baseline (Cycle 1, Day 1 or Day 2 of menstruation). Cycle 2, Day 1 or Day 2 of menstruation (approximately one menstrual cycle [21-35 days] after baseline).
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Anxiety levels are assessed using the Beck Anxiety Inventory (BAI).
The BAI is a 21-item self-report questionnaire with total scores ranging from 0 to 63.
Higher scores indicate more severe anxiety symptoms.
Scores of 0-17 indicate low anxiety, 18-24 moderate anxiety, and 25-63 high anxiety.
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Baseline (Cycle 1, Day 1 or Day 2 of menstruation). Cycle 2, Day 1 or Day 2 of menstruation (approximately one menstrual cycle [21-35 days] after baseline).
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Menstrual symptoms
Periodo de tiempo: Baseline (Cycle 1, Day 1 or Day 2 of menstruation). Cycle 2, Day 1 or Day 2 of menstruation (approximately one menstrual cycle [21-35 days] after baseline).
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Menstrual symptoms are assessed using the Menstrual Symptom Questionnaire (MSQ).
The questionnaire consists of 22 items across three subscales: Negative Effects/Somatic Complaints (13 items), Menstrual Pain Symptoms (6 items), and Coping Methods (3 items).
Each item is scored on a 5-point Likert scale from 1 (never) to 5 (always).
Total scores range from 22 to 110, with higher scores indicating more severe menstrual symptoms.
Higher subscale scores indicate greater severity of symptoms within the corresponding domain.
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Baseline (Cycle 1, Day 1 or Day 2 of menstruation). Cycle 2, Day 1 or Day 2 of menstruation (approximately one menstrual cycle [21-35 days] after baseline).
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Premenstrual syndrome severity
Periodo de tiempo: Baseline (Cycle 1, Day 1 or Day 2 of menstruation). Cycle 2, Day 1 or Day 2 of menstruation (approximately one menstrual cycle [21-35 days] after baseline).
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Premenstrual syndrome symptoms are assessed using the Premenstrual Syndrome Scale (PMSS).
The PMSS is a 44-item self-report questionnaire with nine subscales: depressive affect, anxiety, fatigue, irritability, depressive thoughts, pain, appetite changes, sleep changes, and bloating.
Each item is scored on a 5-point Likert scale from 1 (never) to 5 (always).
Total scores range from 44 to 220, with higher scores indicating greater severity of premenstrual syndrome symptoms.
Higher subscale scores indicate greater symptom severity within the corresponding domain.
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Baseline (Cycle 1, Day 1 or Day 2 of menstruation). Cycle 2, Day 1 or Day 2 of menstruation (approximately one menstrual cycle [21-35 days] after baseline).
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Functional and emotional impact of dysmenorrhea
Periodo de tiempo: Baseline (Cycle 1, Day 1 or Day 2 of menstruation). Cycle 2, Day 1 or Day 2 of menstruation (approximately one menstrual cycle [21-35 days] after baseline).
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Dysmenorrhea-related functional and emotional impact is assessed using the Functional and Emotional Dysmenorrhea Scale (FEDDS).
The FEDDS is a 14-item self-report questionnaire with two subscales.
Each item is rated on a 5-point Likert scale ranging from 1 (does not describe me at all) to 5 (describes me very well).
Total scores indicate the overall level of functional and emotional impairment due to dysmenorrhea, with higher scores indicating greater impairment.
Higher subscale scores indicate greater functional or emotional impact.
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Baseline (Cycle 1, Day 1 or Day 2 of menstruation). Cycle 2, Day 1 or Day 2 of menstruation (approximately one menstrual cycle [21-35 days] after baseline).
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
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
- Hüsniye Merve Demirer. Transcutaneous auricular vagus nerve stimulation in primary dysmenorrhea: effects on pain, menstrual symptoms, depression and anxiety. PhD Thesis, Bahçeşehir University, Istanbul, Turkey, 2024. Available at: https://tez.yok.gov.tr/UlusalTezMerkezi/tezSorguSonucYeni.jsp
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 (Actual)
1 de junio de 2023
Finalización primaria (Actual)
30 de enero de 2024
Finalización del estudio (Actual)
5 de marzo de 2024
Fechas de registro del estudio
Enviado por primera vez
4 de mayo de 2026
Primero enviado que cumplió con los criterios de control de calidad
27 de junio de 2026
Publicado por primera vez (Actual)
6 de julio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
6 de julio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
27 de junio de 2026
Última verificación
1 de junio de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2023-23/113
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Descripción del plan IPD
Individual participant data are not planned to be shared publicly due to privacy and confidentiality concerns.
De-identified aggregated data are reported in the publication.
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. .