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NCT Number: NCT07683637

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

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.

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Key information

Conditions

Primary Dysmenorrhea (PD) Anxiety Disorders Behavior Behavioral Symptoms Depression Dysmenorrhea Menstruation Disturbances Mental Disorders Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Pelvic Pain Primary Dysmenorrhea Signs and Symptoms

Age range

18 year–25 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul Gelisim University

Istanbul, Avcılar, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Transcutaneous Auricular Vagus Nerve Stimulation (taVNS)

Device

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, Auricular vagus nerve stimulation, Transcutaneous Auricular Vagus Nerve Stimulation

Sham transcutaneous auricular vagus nerve stimulation

Device

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

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Sponsors and collaborators

Lead sponsor

Istanbul Gelisim University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jul 6, 2026
Registry last updated
Jul 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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