Primary Dysmenorrhea (PD)NCT07683637

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

A study testing Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) in people with Primary Dysmenorrhea (PD) and Primary Dysmenorrhea, run by Istanbul Gelisim University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 25 years, women only
Conditions the study is for: Primary Dysmenorrhea (PD), Primary Dysmenorrhea
What is being tested?: Transcutaneous Auricular Vagus Nerve Stimulation (taVNS)
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 40 participants
Where: 1 siteTurkey (Türkiye)
Study dates: 1 Jun 2023to 5 Mar 2024
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 25 years
Women only
No healthy volunteers
Adult

Who may be able to join

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

Who cannot join

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

Show all 10Show fewer

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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

Istanbul Gelisim University
Istanbul, Avcılar

Other trials in Turkey (Türkiye)

About this study

Official 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

Read the 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.

Conditions: Primary Dysmenorrhea (PD), Primary Dysmenorrhea
Being tested: Transcutaneous Auricular Vagus Nerve Stimulation (taVNS), Sham transcutaneous auricular vagus nerve stimulation
Keywords: Primary Dysmenorrhea, Transcutaneous Auricular Vagus Nerve Stimulation (taVNS), Vagus Nerve Stimulation, Menstrual Pain, Pain Threshold, Non-invasive Neuromodulation, Depression, Anxiety
Medical subject headings: Dysmenorrhea, Depression, Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Transcutaneous Auricular Vagus Nerve Stimulation (taVNS)Device
Also called taVNS, Auricular vagus nerve stimulation, Transcutaneous Auricular Vagus Nerve Stimulation
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.
Sham transcutaneous auricular vagus nerve stimulationDevice
Also called Sham taVNS, Placebo auricular stimulation, Sham 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.

Study groups in NCT07683637
Study group	Role	What they receive
Transcutaneous auricular vagus nerve stimulation (taVNS)	Experimental	Transcutaneous auricular vagus nerve stimulation (taVNS) 10 sessions during luteal phase Receives: 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 Receives: Device: Sham transcutaneous auricular vagus nerve stimulation

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jun 20235 Mar 2024

First posted6 Jul 2026
Study start1 Jun 2023
Primary completion30 Jan 2024
Study completion5 Mar 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Primary Dysmenorrhea (PD)Studies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07683637
Sponsor's protocol ID: 2023-23/113
Status last verified: Jun 2026
First submitted: 4 May 2026
Last updated: 6 Jul 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: 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.

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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official 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
ClinicalTrials.gov ID: NCT07683637
Acronym / sponsor ID: 2023-23/113
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
Study type: Interventional
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: Istanbul Gelisim UniversityUniversity, hospital or other
Study start: 1 Jun 2023 (actual)
Primary completion: 30 Jan 2024 (actual)
Study completion: 5 Mar 2024 (actual)
First posted: 6 Jul 2026 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Outcome measures will include pain intensity, pain threshold, depression, anxiety, menstrual symptoms, premenstrual syndrome severity, and functional and emotional impact of dysmenorrhea.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
Transcutaneous auricular vagus nerve stimulation (taVNS)	Experimental	Device: Transcutaneous Auricular Vagus Nerve Stimulation (taVNS)Transcutaneous auricular vagus nerve stimulation (taVNS) 10 sessions during luteal phase
Sham transcutaneous auricular vagus nerve stimulation	Sham comparator	Device: Sham transcutaneous auricular vagus nerve stimulationSham transcutaneous auricular vagus nerve stimulation 10 sessions during luteal phase

Who may qualify

Ages: 18 to 25 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (10 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Transcutaneous Auricular Vagus Nerve Stimulation (taVNS)Also: taVNS, Auricular vagus nerve stimulation, Transcutaneous Auricular Vagus Nerve StimulationParticipants 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.	Device	Transcutaneous auricular vagus nerve stimulation (taVNS)
Sham transcutaneous auricular vagus nerve stimulationAlso: Sham taVNS, Placebo auricular stimulation, Sham vagus nerve stimulationParticipants 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.	Device	Sham transcutaneous auricular vagus nerve stimulation

Primary outcome

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.
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.

5 secondary outcomes

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).
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).
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).
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).
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).

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
Results publicationHüsniye 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
Full text of the PhD thesis available in the National Thesis Center (YÖK Thesis Database)Link provided by the sponsor.
Individual participant dataSharing planned: No. 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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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07683637, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2026.