Effect of Auricular Vagus Nerve Stimulation on Pain and Symptoms in Primary Dysmenorrhea
27. juni 2026 oppdatert av: 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.
Studieoversikt
Status
Fullført
Detaljert beskrivelse
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.
Studietype
Intervensjonell
Registrering (Faktiske)
40
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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-
Avcılar
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Istanbul, Avcılar, Tyrkia (Türkiye)
- Istanbul Gelisim University
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
Tar imot friske frivillige
Nei
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: 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.
Andre navn:
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Sham-komparator: 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.
Andre navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Menstrual pain intensity
Tidsramme: 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
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Depression level
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Generelle publikasjoner
- 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
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
1. juni 2023
Primær fullføring (Faktiske)
30. januar 2024
Studiet fullført (Faktiske)
5. mars 2024
Datoer for studieregistrering
Først innsendt
4. mai 2026
Først innsendt som oppfylte QC-kriteriene
27. juni 2026
Først lagt ut (Faktiske)
6. juli 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
6. juli 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
27. juni 2026
Sist bekreftet
1. juni 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 2023-23/113
Plan for individuelle deltakerdata (IPD)
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NEI
IPD-planbeskrivelse
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.
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