Dysmenorrhea PrimaryNCT06146569

Effects of Transcutaneous Vagus Nerve Stimulation (taVNS) in Individuals With Primary Dysmenorrhea

A study testing Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) in people with Dysmenorrhea Primary and Pain, run by Artvin Coruh 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 pain, functional and emotional symptoms, and physical performance in individuals with primary dysmenorrhea (PD). Read more about this study

Who is it for?: Ages 18 to 40 years, women only
Conditions the study is for: Dysmenorrhea Primary, Pain
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: 50 participants
Where: 1 siteTurkey (Türkiye)
Study dates: 15 Nov 2023to 30 Jan 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 40 years
Women only
No healthy volunteers
Adult

Who may be able to join

Being diagnosed with PD according to the No. 345 Primary Dysmenorrhea Consensus Guidelines,
An NRS score of at least three during menstruation before treatment,
Being a woman between the ages of 18-40,
A regular menstrual cycle of 28±7 days,
Being nulliparous,
No history of brain surgery, tumour or intracranial metal implantation,
No chronic genitourinary infection or alcohol or drug use.

Who cannot join

History of dizziness or epileptic disease,
Pregnancy,
Women with intrauterine devices,
Metal implants in the head area,
Women with skin lesions in the area where the electrodes will be placed,
Use of analgesic drugs during treatment,
Women with neurological or heart disease,
Women are diagnosed with gynaecological conditions (endometriosis, adenomyosis, uterine fibroids, etc., which may be associated with secondary dysmenorrhea).

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

Zeynep Yıldız Kızkın
Artvin, 08000

Other trials in Turkey (Türkiye)

About this study

Official title: Effects of Transcutaneous Vagus Nerve Stimulation (taVNS) in Individuals With Primary Dysmenorrhea: A Randomized Controlled Study

Read the detailed description

In this study, which will be conducted over two menstrual cycles, 34 patients with PD will be randomised into two groups: taVNS and sham treatment. From the onset of pain during the menstrual cycle, taVNS or sham treatment will be applied for five days. Pain assessment will be conducted using the Numerical Rating Scale (NRS), pressure pain threshold with an algometer, menstrual symptoms using the Menstrual Symptom Scale (MSS) and the Functional and Emotional Measure of Dysmenorrhea (FEMD), anxiety using the Hamilton Anxiety Scale (HAM-A), and physical performance using the 6-Minute Walk Test (6MWT) during the first and second menstruation.

Conditions: Dysmenorrhea Primary, Pain
Being tested: Transcutaneous Auricular Vagus Nerve Stimulation (taVNS), Sham Transcutaneous Auricular Vagus Nerve Stimulation (taVNS)
Keywords: Dysmenorrhea, Menstrual cycle, Pain, Function
Medical subject headings: Pain, Dysmenorrhea

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
Current will be applied bilaterally from the tragus and turbinate parts of the ear with the VagustimTM device. The current frequency to be used in modulation mode is 10 Hz, and the pulse width is 300 μs (In modulation mode, the pulse rate and width are automatically changed in a loop pattern. The pulse width is reduced by 50% from its original setting in 0.5 seconds; then, the pulse rate is changed in 0.5 seconds, reduced by 50% from the original setting. Total cycle time is 1 second.). The current intensity will be applied for 5 minutes, keeping the current constant where the participant feels comfortable.
Sham Transcutaneous Auricular Vagus Nerve Stimulation (taVNS)Device
For 5 minutes, sham applications will be applied using a current-free headset specifically designed for this purpose. Participants will observe the device's functionality, but it will not supply any current.

Study groups in NCT06146569
Study group	Role	What they receive
Transcutaneous Auricular Vagus Nerve Stimulation	Experimental	Each patient in the Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) group will receive a treatment protocol consisting of taVNS. The treatment will be administered for five days beginning on the first day of pain experienced between the 1st and 2nd menstrual cycles. Receives: Device: Transcutaneous Auricular Vagus Nerve Stimulation (taVNS)
Sham Transcutaneous Auricular Vagus Nerve Stimulation	Sham comparator	Each patient in the sham Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) group will receive a treatment protocol consisting of sham taVNS. The treatment will be administered for five days beginning on the first day of pain experienced between the 1st and 2nd menstrual cycles. Receives: Device: Sham Transcutaneous Auricular Vagus Nerve Stimulation (taVNS)

What is being measured

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

Pain Intensity
Numerical Rating Scale (NRS) data will be queried separately for lower abdominal, waist and bilateral thigh pain. Participants will be required to fill out an NRS questionnaire through the Google Forms web survey platform (Google LLC, Mountain View, CA, USA) before going to bed at night on days 1, 2, and 3 of two consecutive menstrual cycles. The questionnaire will be based on the most severe pain they experienced during the day. The minimum score of the NRS is 0, and the maximum score is 10. Higher scores are associated with more severe pain intensity.
Measured: On the 1st menstrual day before the intervention
Pain Intensity
Numerical Rating Scale (NRS) data will be queried separately for lower abdominal, waist and bilateral thigh pain. Participants will be required to fill out an NRS questionnaire through the Google Forms web survey platform (Google LLC, Mountain View, CA, USA) before going to bed at night on days 1, 2, and 3 of two consecutive menstrual cycles. The questionnaire will be based on the most severe pain they experienced during the day. The minimum score of the NRS is 0, and the maximum score is 10. Higher scores are associated with more severe pain intensity.
Measured: On the 2nd menstrual day before the intervention
Pain Intensity
Numerical Rating Scale (NRS) data will be queried separately for lower abdominal, waist and bilateral thigh pain. Participants will be required to fill out an NRS questionnaire through the Google Forms web survey platform (Google LLC, Mountain View, CA, USA) before going to bed at night on days 1, 2, and 3 of two consecutive menstrual cycles. The questionnaire will be based on the most severe pain they experienced during the day. The minimum score of the NRS is 0, and the maximum score is 10. Higher scores are associated with more severe pain intensity.
Measured: On the 3rd menstrual day before the intervention
Pain Intensity
Numerical Rating Scale (NRS) data will be queried separately for lower abdominal, waist and bilateral thigh pain. Participants will be required to fill out an NRS questionnaire through the Google Forms web survey platform (Google LLC, Mountain View, CA, USA) before going to bed at night on days 1, 2, and 3 of two consecutive menstrual cycles. The questionnaire will be based on the most severe pain they experienced during the day. The minimum score of the NRS is 0, and the maximum score is 10. Higher scores are associated with more severe pain intensity.
Measured: On the 1st day of menstruation when the intervention occurred
Pain Intensity
Numerical Rating Scale (NRS) data will be queried separately for lower abdominal, waist and bilateral thigh pain. Participants will be required to fill out an NRS questionnaire through the Google Forms web survey platform (Google LLC, Mountain View, CA, USA) before going to bed at night on days 1, 2, and 3 of two consecutive menstrual cycles. The questionnaire will be based on the most severe pain they experienced during the day. The minimum score of the NRS is 0, and the maximum score is 10. Higher scores are associated with more severe pain intensity.
Measured: On the 2nd day of menstruation when the intervention occurred
Pain Intensity
Numerical Rating Scale (NRS) data will be queried separately for lower abdominal, waist and bilateral thigh pain. Participants will be required to fill out an NRS questionnaire through the Google Forms web survey platform (Google LLC, Mountain View, CA, USA) before going to bed at night on days 1, 2, and 3 of two consecutive menstrual cycles. The questionnaire will be based on the most severe pain they experienced during the day. The minimum score of the NRS is 0, and the maximum score is 10. Higher scores are associated with more severe pain intensity.
Measured: On the 3rd day of menstruation when the intervention occurred
Pain Pressure Threshold
To measure the pressure pain threshold, it will be used a Push-Pull Force Gauge® (1200-304) will be used by Fabrication Enterprises, Inc. This handheld algometer allows linear force application ranging between 0 and 10 kg (22 lb × ¼ lb and 10 kg × 100 g). Initially, two exercises will be performed on the extensor muscles of the dominant forearm so that patients can become familiar with the equipment. The evaluator will position the algometer perpendicular to each point and apply gradual pressure at a constant rate of approximately 0.5 kg/cm2/s. The pressure will be increased until the participant reports feeling pain. Each point will be evaluated three times, and the average value will be recorded. The measurement will be performed on five reference points in the abdomen and one reference point in the lumbar spine, as in a previous study where pain was evaluated in PD.
Measured: On the 1st menstrual day before the intervention
Pain Pressure Threshold
To measure the pressure pain threshold, it will be used a Push-Pull Force Gauge® (1200-304) will be used by Fabrication Enterprises, Inc. This handheld algometer allows linear force application ranging between 0 and 10 kg (22 lb × ¼ lb and 10 kg × 100 g). Initially, two exercises will be performed on the extensor muscles of the dominant forearm so that patients can become familiar with the equipment. The evaluator will position the algometer perpendicular to each point and apply gradual pressure at a constant rate of approximately 0.5 kg/cm2/s. The pressure will be increased until the participant reports feeling pain. Each point will be evaluated three times, and the average value will be recorded. The measurement will be performed on five reference points in the abdomen and one reference point in the lumbar spine, as in a previous study where pain was evaluated in PD.
Measured: Immediately after the intervention

Secondary outcomes (10)

Menstrual Symptom Scale (MSS)
The scale consists of 22 items and uses a 5-point Likert-type format. Participants are asked to rate the severity of their menstrual symptoms on a scale of 1 (never) to 5 (always). The scale contains three subscales: 'Negative Effects/Somatic Complaints' (items 1-13), 'Menstrual Pain Symptoms' (items 14-19), and 'Coping Methods' (items 20-22). The maximum score on the scale is 110, and the minimum score is 22. MSS score is calculated by taking the average score of all items in the scale. High scores are associated with increased menstrual symptoms.
Measured: On the 1st menstrual day before the intervention
Menstrual Symptom Scale (MSS)
The scale consists of 22 items and uses a 5-point Likert-type format. Participants are asked to rate the severity of their menstrual symptoms on a scale of 1 (never) to 5 (always). The scale contains three subscales: 'Negative Effects/Somatic Complaints' (items 1-13), 'Menstrual Pain Symptoms' (items 14-19), and 'Coping Methods' (items 20-22). The maximum score on the scale is 110, and the minimum score is 22. MSS score is calculated by taking the average score of all items in the scale. High scores are associated with increased menstrual symptoms.
Measured: Immediately after the intervention
Functional and Emotional Measure of Dysmenorrhea (FEMD)
Functional and Emotional Measure of Dysmenorrhea (FEMD), consisting of 14 items, evaluates dysmenorrhea functionally and emotionally with a 5-point Likert-type item. The reliability and validity study of the scale developed in 2012 was conducted in Turkey in 2015. As the scores obtained from the scale with a minimum score of 14 and a maximum score of 70 increase, the functional and emotional impact of dysmenorrhea also increases.
Measured: On the 1st menstrual day before the intervention
Functional and Emotional Measure of Dysmenorrhea (FEMD)
Functional and Emotional Measure of Dysmenorrhea (FEMD), consisting of 14 items, evaluates dysmenorrhea functionally and emotionally with a 5-point Likert-type item. The reliability and validity study of the scale developed in 2012 was conducted in Turkey in 2015. As the scores obtained from the scale with a minimum score of 14 and a maximum score of 70 increase, the functional and emotional impact of dysmenorrhea also increases.
Measured: Immediately after the intervention
Hamilton Anxiety Scale (HAM-A)
Patients with chronic pain often experience mood disorders, such as depression and anxiety. The Hamilton Anxiety Scale (HAM-A) will be used to assess the intensity of anxiety symptoms. The scale measures both mental and physical anxiety with 14 symptom-defined items. Each item is scored from 0 (not present) to 4 (severe). The total score range is 0-56. On the anxiety scale, scores of 17 or below indicate mild anxiety, while scores of 18-24 indicate moderate anxiety, and scores of 25-30 indicate severe anxiety.
Measured: On the 1st menstrual day before the intervention
Hamilton Anxiety Scale (HAM-A)
Patients with chronic pain often experience mood disorders, such as depression and anxiety. The Hamilton Anxiety Scale (HAM-A) will be used to assess the intensity of anxiety symptoms. The scale measures both mental and physical anxiety with 14 symptom-defined items. Each item is scored from 0 (not present) to 4 (severe). The total score range is 0-56. On the anxiety scale, scores of 17 or below indicate mild anxiety, while scores of 18-24 indicate moderate anxiety, and scores of 25-30 indicate severe anxiety.
Measured: Immediately after the intervention
6-Minute Walk Test (6MWT)
The 6-Minute Walk Test (6MWT) will evaluate submaximal functional capacity. 6MWT measures the maximum distance participants can walk as quickly as possible for 6 minutes.
Measured: On the 1st menstrual day before the intervention
6-Minute Walk Test (6MWT)
The 6-Minute Walk Test (6MWT) will evaluate submaximal functional capacity. 6MWT measures the maximum distance participants can walk as quickly as possible for 6 minutes.
Measured: Immediately after the intervention
Positive and Negative Affect Schedule (PANAS)
For taVNS administration, the positive and negative affect will be assessed before and after treatment using the Positive and Negative Affect Schedule (PANAS). This 5-point Likert-type scale was developed in 1988 and includes 20 items: 10 positive and 10 negative. A score range of 10-50 assesses both positive and negative effects.
Measured: On the 1st menstrual day before the intervention
Positive and Negative Affect Schedule (PANAS)
For taVNS administration, the positive and negative affect will be assessed before and after treatment using the Positive and Negative Affect Schedule (PANAS). This 5-point Likert-type scale was developed in 1988 and includes 20 items: 10 positive and 10 negative. A score range of 10-50 assesses both positive and negative effects.
Measured: Immediately after the intervention

Timeline

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

15 Nov 202330 Jan 2024

First posted24 Nov 2023
Study start15 Nov 2023
Primary completion15 Jan 2024
Study completion30 Jan 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (11)Papers the sponsor has linked to this study.
Other trials for Dysmenorrhea PrimaryStudies 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
Model description: Two treatment groups have been formed to receive taVNS and sham taVNS.
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 50 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06146569
Sponsor's protocol ID: Vagus Nerve Stimulation
Status last verified: Oct 2024
First submitted: 13 Nov 2023
Last updated: 29 Oct 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Burnett M, Lemyre M. No. 345-Primary Dysmenorrhea Consensus Guideline. J Obstet Gynaecol Can. 2017 Jul;39(7):585-595. doi: 10.1016/j.jogc.2016.12.023.
PubMed 28625286
Itani R, Soubra L, Karout S, Rahme D, Karout L, Khojah HMJ. Primary Dysmenorrhea: Pathophysiology, Diagnosis, and Treatment Updates. Korean J Fam Med. 2022 Mar;43(2):101-108. doi: 10.4082/kjfm.21.0103. Epub 2022 Mar 17.
PubMed 35320895
Karout S, Soubra L, Rahme D, Karout L, Khojah HMJ, Itani R. Prevalence, risk factors, and management practices of primary dysmenorrhea among young females. BMC Womens Health. 2021 Nov 8;21(1):392. doi: 10.1186/s12905-021-01532-w.
PubMed 34749716
Ju H, Jones M, Mishra G. The prevalence and risk factors of dysmenorrhea. Epidemiol Rev. 2014;36:104-13. doi: 10.1093/epirev/mxt009. Epub 2013 Nov 26.
PubMed 24284871
Habibi N, Huang MS, Gan WY, Zulida R, Safavi SM. Prevalence of Primary Dysmenorrhea and Factors Associated with Its Intensity Among Undergraduate Students: A Cross-Sectional Study. Pain Manag Nurs. 2015 Dec;16(6):855-61. doi: 10.1016/j.pmn.2015.07.001. Epub 2015 Aug 29.
PubMed 26328887
Wang L, Wang Y, Wang Y, Wang F, Zhang J, Li S, Wu M, Li L, Rong P. Transcutaneous auricular vagus nerve stimulators: a review of past, present, and future devices. Expert Rev Med Devices. 2022 Jan;19(1):43-61. doi: 10.1080/17434440.2022.2020095. Epub 2022 Jan 13.
PubMed 34937487
Wang YJ, Hsu CC, Yeh ML, Lin JG. Auricular acupressure to improve menstrual pain and menstrual distress and heart rate variability for primary dysmenorrhea in youth with stress. Evid Based Complement Alternat Med. 2013;2013:138537. doi: 10.1155/2013/138537. Epub 2013 Dec 12.
PubMed 24416063
Pegado R, Silva LK, da Silva Dantas H, Andrade Camara H, Andrade Mescouto K, Silva-Filho EM, Lopes JM, Micussi MTABC, Correia GN. Effects of Transcranial Direct Current Stimulation for Treatment of Primary Dysmenorrhea: Preliminary Results of a Randomized Sham-Controlled Trial. Pain Med. 2020 Dec 25;21(12):3615-3623. doi: 10.1093/pm/pnz202.
PubMed 31498389
Dutra LRDV, Pegado R, Silva LK, da Silva Dantas H, Camara HA, Silva-Filho EM, Correia GN, Micussi MTABC. Modulating Anxiety and Functional Capacity with Anodal tDCS Over the Left Dorsolateral Prefrontal Cortex in Primary Dysmenorrhea. Int J Womens Health. 2020 Apr 5;12:243-251. doi: 10.2147/IJWH.S226501. eCollection 2020.
PubMed 32308497
Kane RL, Bershadsky B, Rockwood T, Saleh K, Islam NC. Visual Analog Scale pain reporting was standardized. J Clin Epidemiol. 2005 Jun;58(6):618-23. doi: 10.1016/j.jclinepi.2004.11.017.
PubMed 15878476
Yildiz Kizkin Z, Yildiz R, Ozden AV. Effects of Transcutaneous Auricular Vagus Nerve Stimulation in Individuals with Primary Dysmenorrhea: A Randomized Controlled Trial. Neuromodulation. 2026 Jun;29(4):576-587. doi: 10.1016/j.neurom.2025.09.306. Epub 2025 Oct 17.
PubMed 41108303

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?

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All Dysmenorrhea Primary trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effects of Transcutaneous Vagus Nerve Stimulation (taVNS) in Individuals With Primary Dysmenorrhea: A Randomized Controlled Study
ClinicalTrials.gov ID: NCT06146569
Acronym / sponsor ID: Vagus Nerve Stimulation
Conditions: Dysmenorrhea Primary, Pain
Keywords: Dysmenorrhea, Menstrual cycle, Pain, Function
Study type: Interventional
Recruitment status: Completed
Enrolment: 50 participants (actual)
Lead sponsor: Artvin Coruh UniversityUniversity, hospital or other
Study start: 15 Nov 2023 (actual)
Primary completion: 15 Jan 2024 (actual)
Study completion: 30 Jan 2024 (actual)
First posted: 24 Nov 2023 (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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2
Model description: Two treatment groups have been formed to receive taVNS and sham taVNS.

Arm	Type	Receives
Transcutaneous Auricular Vagus Nerve Stimulation	Experimental	Device: Transcutaneous Auricular Vagus Nerve Stimulation (taVNS)Each patient in the Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) group will receive a treatment protocol consisting of taVNS. The treatment will be administered for five days beginning on the first day of pain experienced between the 1st and 2nd menstrual cycles.
Sham Transcutaneous Auricular Vagus Nerve Stimulation	Sham comparator	Device: Sham Transcutaneous Auricular Vagus Nerve Stimulation (taVNS)Each patient in the sham Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) group will receive a treatment protocol consisting of sham taVNS. The treatment will be administered for five days beginning on the first day of pain experienced between the 1st and 2nd menstrual cycles.

Who may qualify

Ages: 18 to 40 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (7 listed)

Being diagnosed with PD according to the No. 345 Primary Dysmenorrhea Consensus Guidelines,
An NRS score of at least three during menstruation before treatment,
Being a woman between the ages of 18-40,
A regular menstrual cycle of 28±7 days,
Being nulliparous,

Key exclusion criteria (8 listed)

History of dizziness or epileptic disease,
Pregnancy,
Women with intrauterine devices,
Metal implants in the head area,
Women with skin lesions in the area where the electrodes will be placed,

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)Current will be applied bilaterally from the tragus and turbinate parts of the ear with the VagustimTM device. The current frequency to be used in modulation mode is 10 Hz, and the pulse width is 300 μs (In modulation mode, the pulse rate and width are automatically changed in a loop pattern. The pulse width is reduced by 50% from its original setting in 0.5 seconds; then, the pulse rate is changed in 0.5 seconds, reduced by 50% from the original setting. Total cycle time is 1 second.). The current intensity will be applied for 5 minutes, keeping the current constant where the participant feels comfortable.	Device	Transcutaneous Auricular Vagus Nerve Stimulation
Sham Transcutaneous Auricular Vagus Nerve Stimulation (taVNS)For 5 minutes, sham applications will be applied using a current-free headset specifically designed for this purpose. Participants will observe the device's functionality, but it will not supply any current.	Device	Sham Transcutaneous Auricular Vagus Nerve Stimulation

Primary outcome

Pain Intensity
Time frame: On the 1st menstrual day before the intervention
Numerical Rating Scale (NRS) data will be queried separately for lower abdominal, waist and bilateral thigh pain. Participants will be required to fill out an NRS questionnaire through the Google Forms web survey platform (Google LLC, Mountain View, CA, USA) before going to bed at night on days 1, 2, and 3 of two consecutive menstrual cycles. The questionnaire will be based on the most severe pain they experienced during the day. The minimum score of the NRS is 0, and the maximum score is 10. Higher scores are associated with more severe pain intensity.
Pain Intensity
Time frame: On the 2nd menstrual day before the intervention
Numerical Rating Scale (NRS) data will be queried separately for lower abdominal, waist and bilateral thigh pain. Participants will be required to fill out an NRS questionnaire through the Google Forms web survey platform (Google LLC, Mountain View, CA, USA) before going to bed at night on days 1, 2, and 3 of two consecutive menstrual cycles. The questionnaire will be based on the most severe pain they experienced during the day. The minimum score of the NRS is 0, and the maximum score is 10. Higher scores are associated with more severe pain intensity.
Pain Intensity
Time frame: On the 3rd menstrual day before the intervention
Numerical Rating Scale (NRS) data will be queried separately for lower abdominal, waist and bilateral thigh pain. Participants will be required to fill out an NRS questionnaire through the Google Forms web survey platform (Google LLC, Mountain View, CA, USA) before going to bed at night on days 1, 2, and 3 of two consecutive menstrual cycles. The questionnaire will be based on the most severe pain they experienced during the day. The minimum score of the NRS is 0, and the maximum score is 10. Higher scores are associated with more severe pain intensity.
Pain Intensity
Time frame: On the 1st day of menstruation when the intervention occurred
Numerical Rating Scale (NRS) data will be queried separately for lower abdominal, waist and bilateral thigh pain. Participants will be required to fill out an NRS questionnaire through the Google Forms web survey platform (Google LLC, Mountain View, CA, USA) before going to bed at night on days 1, 2, and 3 of two consecutive menstrual cycles. The questionnaire will be based on the most severe pain they experienced during the day. The minimum score of the NRS is 0, and the maximum score is 10. Higher scores are associated with more severe pain intensity.
Pain Intensity
Time frame: On the 2nd day of menstruation when the intervention occurred
Numerical Rating Scale (NRS) data will be queried separately for lower abdominal, waist and bilateral thigh pain. Participants will be required to fill out an NRS questionnaire through the Google Forms web survey platform (Google LLC, Mountain View, CA, USA) before going to bed at night on days 1, 2, and 3 of two consecutive menstrual cycles. The questionnaire will be based on the most severe pain they experienced during the day. The minimum score of the NRS is 0, and the maximum score is 10. Higher scores are associated with more severe pain intensity.
Pain Intensity
Time frame: On the 3rd day of menstruation when the intervention occurred
Numerical Rating Scale (NRS) data will be queried separately for lower abdominal, waist and bilateral thigh pain. Participants will be required to fill out an NRS questionnaire through the Google Forms web survey platform (Google LLC, Mountain View, CA, USA) before going to bed at night on days 1, 2, and 3 of two consecutive menstrual cycles. The questionnaire will be based on the most severe pain they experienced during the day. The minimum score of the NRS is 0, and the maximum score is 10. Higher scores are associated with more severe pain intensity.
Pain Pressure Threshold
Time frame: On the 1st menstrual day before the intervention
To measure the pressure pain threshold, it will be used a Push-Pull Force Gauge® (1200-304) will be used by Fabrication Enterprises, Inc. This handheld algometer allows linear force application ranging between 0 and 10 kg (22 lb × ¼ lb and 10 kg × 100 g). Initially, two exercises will be performed on the extensor muscles of the dominant forearm so that patients can become familiar with the equipment. The evaluator will position the algometer perpendicular to each point and apply gradual pressure at a constant rate of approximately 0.5 kg/cm2/s. The pressure will be increased until the participant reports feeling pain. Each point will be evaluated three times, and the average value will be recorded. The measurement will be performed on five reference points in the abdomen and one reference point in the lumbar spine, as in a previous study where pain was evaluated in PD.
Pain Pressure Threshold
Time frame: Immediately after the intervention
To measure the pressure pain threshold, it will be used a Push-Pull Force Gauge® (1200-304) will be used by Fabrication Enterprises, Inc. This handheld algometer allows linear force application ranging between 0 and 10 kg (22 lb × ¼ lb and 10 kg × 100 g). Initially, two exercises will be performed on the extensor muscles of the dominant forearm so that patients can become familiar with the equipment. The evaluator will position the algometer perpendicular to each point and apply gradual pressure at a constant rate of approximately 0.5 kg/cm2/s. The pressure will be increased until the participant reports feeling pain. Each point will be evaluated three times, and the average value will be recorded. The measurement will be performed on five reference points in the abdomen and one reference point in the lumbar spine, as in a previous study where pain was evaluated in PD.

10 secondary outcomes

Menstrual Symptom Scale (MSS)
Time frame: On the 1st menstrual day before the intervention
Menstrual Symptom Scale (MSS)
Time frame: Immediately after the intervention
Functional and Emotional Measure of Dysmenorrhea (FEMD)
Time frame: On the 1st menstrual day before the intervention
Functional and Emotional Measure of Dysmenorrhea (FEMD)
Time frame: Immediately after the intervention
Hamilton Anxiety Scale (HAM-A)
Time frame: On the 1st menstrual day before the intervention
Hamilton Anxiety Scale (HAM-A)
Time frame: Immediately after the intervention
6-Minute Walk Test (6MWT)
Time frame: On the 1st menstrual day before the intervention
6-Minute Walk Test (6MWT)
Time frame: Immediately after the intervention
Positive and Negative Affect Schedule (PANAS)
Time frame: On the 1st menstrual day before the intervention
Positive and Negative Affect Schedule (PANAS)
Time frame: Immediately after the intervention

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 29 Oct 2024.
Background: PubMed 28625286Burnett M, Lemyre M. No. 345-Primary Dysmenorrhea Consensus Guideline. J Obstet Gynaecol Can. 2017 Jul;39(7):585-595. doi: 10.1016/j.jogc.2016.12.023.
Background: PubMed 35320895Itani R, Soubra L, Karout S, Rahme D, Karout L, Khojah HMJ. Primary Dysmenorrhea: Pathophysiology, Diagnosis, and Treatment Updates. Korean J Fam Med. 2022 Mar;43(2):101-108. doi: 10.4082/kjfm.21.0103. Epub 2022 Mar 17.
Background: PubMed 34749716Karout S, Soubra L, Rahme D, Karout L, Khojah HMJ, Itani R. Prevalence, risk factors, and management practices of primary dysmenorrhea among young females. BMC Womens Health. 2021 Nov 8;21(1):392. doi: 10.1186/s12905-021-01532-w.
Background: PubMed 24284871Ju H, Jones M, Mishra G. The prevalence and risk factors of dysmenorrhea. Epidemiol Rev. 2014;36:104-13. doi: 10.1093/epirev/mxt009. Epub 2013 Nov 26.
Background: PubMed 26328887Habibi N, Huang MS, Gan WY, Zulida R, Safavi SM. Prevalence of Primary Dysmenorrhea and Factors Associated with Its Intensity Among Undergraduate Students: A Cross-Sectional Study. Pain Manag Nurs. 2015 Dec;16(6):855-61. doi: 10.1016/j.pmn.2015.07.001. Epub 2015 Aug 29.
Background: PubMed 34937487Wang L, Wang Y, Wang Y, Wang F, Zhang J, Li S, Wu M, Li L, Rong P. Transcutaneous auricular vagus nerve stimulators: a review of past, present, and future devices. Expert Rev Med Devices. 2022 Jan;19(1):43-61. doi: 10.1080/17434440.2022.2020095. Epub 2022 Jan 13.
Background: PubMed 24416063Wang YJ, Hsu CC, Yeh ML, Lin JG. Auricular acupressure to improve menstrual pain and menstrual distress and heart rate variability for primary dysmenorrhea in youth with stress. Evid Based Complement Alternat Med. 2013;2013:138537. doi: 10.1155/2013/138537. Epub 2013 Dec 12.
Background: PubMed 31498389Pegado R, Silva LK, da Silva Dantas H, Andrade Camara H, Andrade Mescouto K, Silva-Filho EM, Lopes JM, Micussi MTABC, Correia GN. Effects of Transcranial Direct Current Stimulation for Treatment of Primary Dysmenorrhea: Preliminary Results of a Randomized Sham-Controlled Trial. Pain Med. 2020 Dec 25;21(12):3615-3623. doi: 10.1093/pm/pnz202.
Background: PubMed 32308497Dutra LRDV, Pegado R, Silva LK, da Silva Dantas H, Camara HA, Silva-Filho EM, Correia GN, Micussi MTABC. Modulating Anxiety and Functional Capacity with Anodal tDCS Over the Left Dorsolateral Prefrontal Cortex in Primary Dysmenorrhea. Int J Womens Health. 2020 Apr 5;12:243-251. doi: 10.2147/IJWH.S226501. eCollection 2020.
Background: PubMed 15878476Kane RL, Bershadsky B, Rockwood T, Saleh K, Islam NC. Visual Analog Scale pain reporting was standardized. J Clin Epidemiol. 2005 Jun;58(6):618-23. doi: 10.1016/j.jclinepi.2004.11.017.
Derived from this study: PubMed 41108303Yildiz Kizkin Z, Yildiz R, Ozden AV. Effects of Transcutaneous Auricular Vagus Nerve Stimulation in Individuals with Primary Dysmenorrhea: A Randomized Controlled Trial. Neuromodulation. 2026 Jun;29(4):576-587. doi: 10.1016/j.neurom.2025.09.306. Epub 2025 Oct 17.
Individual participant dataSharing planned: No

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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.

Zeynep Yıldız Kızkın, Lecturer principal investigator

Artvin Coruh University

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

Questions about this trial

What is this clinical trial studying?

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

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 7 inclusion and 8 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 29 Oct 2024. 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?

Pain Intensity (time frame: On the 1st menstrual day before the intervention). The study lists 8 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 NCT06146569, which also lists 11 linked publications.

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 29 Oct 2024.