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Trial · NCT07880080

Transcutaneous Cervical Vagus Nerve Stimulation for Primary Dysmenorrhea

NCT07880080, Not applicable, Not yet recruiting, Sinop University

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Transcutaneous Cervical Vagus Nerve Stimulation for Primary Dysmenorrhea. Trials, record NCT07880080. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07880080

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title
Transcutaneous Cervical Vagus Nerve Stimulation for Primary Dysmenorrhea
NCT number
NCT07880080
Status
Not yet recruiting
Phases
Not applicable
Enrollment
70 participants, estimated
Lead sponsor
Sinop University
Conditions
Primary Dysmenorrhea (PD), Menstrual Pain
Interventions
Transcutaneous Cervical Vagus Nerve Stimulation, Sham Transcutaneous Cervical Vagus Nerve Stimulation
First posted
2026-10-19
Last updated
2026-10-19

Source ClinicalTrials.gov

Registered outcomes8

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryChange in Menstrual Pain Intensity Assessed by the Numerical Rating ScaleBaseline (Day 1 before the first intervention) through Day 5 of the menstrual cycle
Menstrual pain intensity will be assessed using an 11-point Numerical Rating Scale (NRS) ranging from 0 (no pain) to 10 (worst imaginable pain). Higher scores indicate greater pain intensity. The change in menstrual pain intensity over the study period will be compared between the active tcVNS and sham groups.
PrimaryChange in Multidimensional Menstrual Pain Assessed by the Short-Form McGill Pain QuestionnaireBaseline (Day 1 before intervention) and Day 3 after the final intervention
The Short-Form McGill Pain Questionnaire will be used to assess sensory and affective dimensions of menstrual pain. Fifteen pain descriptors are rated from 0 to 3, generating a total score ranging from 0 to 45. Higher scores indicate greater pain severity. The change in total score will be compared between the active tcVNS and sham groups.
SecondaryChange in Functional and Emotional Impact of DysmenorrheaBaseline (Day 1 before intervention) and Day 3 after the final intervention
The functional and emotional impact of dysmenorrhea will be assessed using the Functional and Emotional Measure of Dysmenorrhea. Higher scores indicate greater functional and emotional impairment associated with dysmenorrhea. Changes in scores will be compared between the active tcVNS and sham groups.
SecondaryChange in Anxiety SymptomsBaseline (Day 1 before intervention) and Day 3 after the final intervention
Anxiety symptoms will be assessed using the Anxiety subscale of the Hospital Anxiety and Depression Scale (HADS-A). Scores range from 0 to 21, with higher scores indicating greater anxiety symptom severity.
SecondaryChange in Depressive SymptomsBaseline (Day 1 before intervention) and Day 3 after the final intervention
Depressive symptoms will be assessed using the Depression subscale of the Hospital Anxiety and Depression Scale (HADS-D). Scores range from 0 to 21, with higher scores indicating greater depressive symptom severity.
SecondaryChange in Menstrual Symptom SeverityBaseline (Day 1 before intervention) and Day 3 after the final intervention
Menstrual symptoms including pelvic cramping, low back pain, headache, nausea, vomiting, diarrhea, constipation, fatigue, dizziness, sleep disturbance, irritability, and difficulty concentrating will be rated from 0 (none) to 3 (severe). Changes in symptom severity will be compared between groups.
SecondaryChange in Autonomic Function Assessed by Heart Rate VariabilityDay 1 before intervention, immediately after the first intervention, and Day 3 after the final intervention
Autonomic function will be assessed using standardized 5-minute RR interval recordings obtained with a Polar H10 chest strap. Recordings will be analyzed using Kubios HRV software. Heart rate variability parameters will include RMSSD, SDNN, LF/HF ratio, and mean heart rate. Changes in these parameters over time will be compared between the active tcVNS and sham groups.
SecondaryAnalgesic Use During MenstruationDaily from Day 1 through Day 5 of the menstrual cycleUse of analgesic medication will be recorded daily, including medication name, dose, and time of administration. Analgesic use will be compared between the active tcVNS and sham groups.

Outcomes0

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

None in this release.

Results by group0

Each measurement the trial posted, group by group, in the words and numbers it posted.

None in this release.

Participant flow0

How many started, completed or left each group, period by period.

None in this release.

Adverse events0

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

None in this release.

Adverse event totals0

The totals the trial posted for each group.

None in this release.

Papers3

The papers the trial lists on ClinicalTrials.gov.

PMIDListed asSource
37076044RESULTPubMed
41108303RESULTPubMed
42252834RESULTPubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT07880080

GET https://conductscience.org/api/trials/v1/NCT07880080/registered