Clinical trial NCT06146569: Effects of Transcutaneous Vagus Nerve Stimulation (taVNS) in Individuals With Primary Dysmenorrhea
Official title: Effects of Transcutaneous Vagus Nerve Stimulation (taVNS) in Individuals With Primary Dysmenorrhea: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dysmenorrhea Primary
Pain
Keywords: Dysmenorrhea
Menstrual cycle
Pain
Function
Lead sponsor: Artvin Coruh University
Sponsor class: OTHER
First posted: 2023-11-24
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two treatment groups have been formed to receive taVNS and sham taVNS.
Primary purpose: TREATMENT

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).

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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).

Primary outcomes:
measure: Pain Intensity
timeFrame: On the 1st menstrual day before the intervention
measure: Pain Intensity
timeFrame: On the 2nd menstrual day before the intervention
measure: Pain Intensity
timeFrame: On the 3rd menstrual day before the intervention
measure: Pain Intensity
timeFrame: On the 1st day of menstruation when the intervention occurred
measure: Pain Intensity
timeFrame: On the 2nd day of menstruation when the intervention occurred
measure: Pain Intensity
timeFrame: On the 3rd day of menstruation when the intervention occurred
measure: Pain Pressure Threshold
timeFrame: On the 1st menstrual day before the intervention
measure: Pain Pressure Threshold
timeFrame: Immediately after the intervention
Secondary outcomes:
measure: Menstrual Symptom Scale (MSS)
timeFrame: On the 1st menstrual day before the intervention
measure: Menstrual Symptom Scale (MSS)
timeFrame: Immediately after the intervention
measure: Functional and Emotional Measure of Dysmenorrhea (FEMD)
timeFrame: On the 1st menstrual day before the intervention
measure: Functional and Emotional Measure of Dysmenorrhea (FEMD)
timeFrame: Immediately after the intervention
measure: Hamilton Anxiety Scale (HAM-A)
timeFrame: On the 1st menstrual day before the intervention
measure: Hamilton Anxiety Scale (HAM-A)
timeFrame: Immediately after the intervention
measure: 6-Minute Walk Test (6MWT)
timeFrame: On the 1st menstrual day before the intervention
measure: 6-Minute Walk Test (6MWT)
timeFrame: Immediately after the intervention
measure: Positive and Negative Affect Schedule (PANAS)
timeFrame: On the 1st menstrual day before the intervention
measure: Positive and Negative Affect Schedule (PANAS)
timeFrame: Immediately after the intervention
Other outcomes:
Locations:
city: Artvin
country: Turkey
facility: Zeynep Yıldız Kızkın
Study officials:
affiliation: Artvin Coruh University
name: Zeynep Yıldız Kızkın, Lecturer
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.