Effect of Auricular Vagus Nerve Stimulation on Pain and Symptoms in Primary Dysmenorrhea

June 27, 2026 updated by: 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
    • Avcılar
      • Istanbul, Avcılar, Turkey (Türkiye)
        • Istanbul Gelisim University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Transcutaneous auricular vagus nerve stimulation (taVNS)
Transcutaneous auricular vagus nerve stimulation (taVNS) 10 sessions during luteal phase
Device: Transcutaneous Auricular Vagus Nerve Stimulation (taVNS)
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.
Other Names:
  • taVNS
  • Transcutaneous Auricular Vagus Nerve Stimulation
  • Auricular vagus nerve stimulation
Sham Comparator: Sham transcutaneous auricular vagus nerve stimulation
Sham transcutaneous auricular vagus nerve stimulation 10 sessions during luteal phase
Device: Sham transcutaneous auricular vagus nerve stimulation
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.
Other Names:
  • Sham taVNS
  • Placebo auricular stimulation
  • Sham vagus nerve stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Menstrual pain intensity
Time Frame: 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).
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.
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).
Pain threshold
Time Frame: 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).
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.
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).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Depression level
Time Frame: 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).
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.
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).
Anxiety level
Time Frame: 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).
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.
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).
Menstrual symptoms
Time Frame: 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).
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.
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).
Premenstrual syndrome severity
Time Frame: 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).
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.
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).
Functional and emotional impact of dysmenorrhea
Time Frame: 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).
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.
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).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul Gelisim University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • 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

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2023

Primary Completion (Actual)

January 30, 2024

Study Completion (Actual)

March 5, 2024

Study Registration Dates

First Submitted

May 4, 2026

First Submitted That Met QC Criteria

June 27, 2026

First Posted (Actual)

July 6, 2026

Study Record Updates

Last Update Posted (Actual)

July 6, 2026

Last Update Submitted That Met QC Criteria

June 27, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-23/113

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Primary Dysmenorrhea

Clinical Trials on Transcutaneous Auricular Vagus Nerve Stimulation (taVNS)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Equatorial Guinea

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe