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

NCT07683637 | Completed

• 1 other identifier: 2023-23/113
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Primary Dysmenorrhea (PD); Primary Dysmenorrhea

Keywords

Primary Dysmenorrhea; Transcutaneous Auricular Vagus Nerve Stimulation (taVNS); Vagus Nerve Stimulation; Menstrual Pain; Pain Threshold; Non-invasive Neuromodulation; Depression; Anxiety

Outcome Measures

Primary Outcomes (2)

• Menstrual pain intensity

  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

  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 Outcomes (5)

• Depression level

  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

  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

  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

  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

  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).

Study Arms (2)

Transcutaneous auricular vagus nerve stimulation (taVNS)

EXPERIMENTAL

Transcutaneous auricular vagus nerve stimulation (taVNS) 10 sessions during luteal phase

Device: Transcutaneous Auricular Vagus Nerve Stimulation (taVNS)

Sham transcutaneous auricular vagus nerve stimulation

SHAM COMPARATOR

Sham transcutaneous auricular vagus nerve stimulation 10 sessions during luteal phase

Device: Sham transcutaneous auricular vagus nerve stimulation

Interventions

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.

Also known as: taVNS, Auricular vagus nerve stimulation, Transcutaneous Auricular Vagus Nerve Stimulation

Transcutaneous auricular vagus nerve stimulation (taVNS)

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.

Also known as: Sham taVNS, Placebo auricular stimulation, Sham vagus nerve stimulation

Sham transcutaneous auricular vagus nerve stimulation

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul Gelisim University: lead

Study Sites (1)

Istanbul Gelisim University

Istanbul, Avcılar, Turkey (Türkiye)

Location

Related Publications (1)

• 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

  RESULT

Related Links

• Full text of the PhD thesis available in the National Thesis Center (YÖK Thesis Database)

MeSH Terms

Conditions

Dysmenorrhea; Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Menstruation Disturbances; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pelvic Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Behavioral Symptoms; Behavior; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 4, 2026
• First Posted: July 6, 2026
• Study Start: June 1, 2023
• Primary Completion: January 30, 2024
• Study Completion: March 5, 2024
• Last Updated: July 6, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)