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

NCT06146569 | Completed

• 1 other identifier: Vagus Nerve Stimulation
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Dysmenorrhea Primary; Pain

Keywords

Dysmenorrhea; Menstrual cycle; Pain; Function

Outcome Measures

Primary Outcomes (8)

• 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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  Immediately after the intervention

Secondary Outcomes (10)

• Menstrual Symptom Scale (MSS)

  On the 1st menstrual day before the intervention

• Menstrual Symptom Scale (MSS)

  Immediately after the intervention

• Functional and Emotional Measure of Dysmenorrhea (FEMD)

  On the 1st menstrual day before the intervention

• Functional and Emotional Measure of Dysmenorrhea (FEMD)

  Immediately after the intervention

• Hamilton Anxiety Scale (HAM-A)

  On the 1st menstrual day before the intervention

Study Arms (2)

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.

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.

Device: Sham Transcutaneous Auricular Vagus Nerve Stimulation (taVNS)

Interventions

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.

Transcutaneous Auricular Vagus Nerve Stimulation

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.

Sham Transcutaneous Auricular Vagus Nerve Stimulation

Eligibility Criteria

• Age: 18 Years - 40 Years
• Gender Eligibility Details: Only women with primary dysmenorrhea will be included.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Artvin Coruh University: lead

Study Sites (1)

Zeynep Yıldız Kızkın

Artvin, 08000, Turkey (Türkiye)

Location

Related Publications (11)

• 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.

  PMID: 28625286 BACKGROUND

• 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.

  PMID: 35320895 BACKGROUND

• 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.

  PMID: 34749716 BACKGROUND

• 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.

  PMID: 24284871 BACKGROUND

• 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.

  PMID: 26328887 BACKGROUND

• 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.

  PMID: 34937487 BACKGROUND

• 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.

  PMID: 24416063 BACKGROUND

• 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.

  PMID: 31498389 BACKGROUND

• 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.

  PMID: 32308497 BACKGROUND

• 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.

  PMID: 15878476 BACKGROUND

• Yildiz Kizkin Z, Yildiz R, Ozden AV. Effects of Transcutaneous Auricular Vagus Nerve Stimulation in Individuals with Primary Dysmenorrhea: A Randomized Controlled Trial. Neuromodulation. 2025 Oct 17:S1094-7159(25)01031-1. doi: 10.1016/j.neurom.2025.09.306. Online ahead of print.

  PMID: 41108303 DERIVED

MeSH Terms

Conditions

Pain; Dysmenorrhea

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Menstruation Disturbances; Pathologic Processes; Pelvic Pain

Study Officials

• Zeynep Yıldız Kızkın, Lecturer

  Artvin Coruh University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Throughout the study, participants and researchers involved in assessments and interventions will remain blinded to group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Model Details: Two treatment groups have been formed to receive taVNS and sham taVNS.

Study Record Dates

• First Submitted: November 13, 2023
• First Posted: November 24, 2023
• Study Start: November 15, 2023
• Primary Completion: January 15, 2024
• Study Completion: January 30, 2024
• Last Updated: October 29, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)