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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Transcutaneous auricular vagus nerve stimulation (taVNS) | Experimental | Transcutaneous auricular vagus nerve stimulation (taVNS) 10 sessions during luteal phase |
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| Sham transcutaneous auricular vagus nerve stimulation | Sham Comparator | Sham transcutaneous auricular vagus nerve stimulation 10 sessions during luteal phase |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Istanbul Gelisim University | Istanbul | Avcılar | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | 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 |
| Label | URL |
|---|---|
| Full text of the PhD thesis available in the National Thesis Center (YÖK Thesis Database) | View source |
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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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| Sham transcutaneous auricular vagus nerve stimulation | Device | 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. |
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| 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. | 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. | 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. | 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. | 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). |
| ID | Term |
|---|---|
| D004412 | Dysmenorrhea |
| D003863 | Depression |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D008599 | Menstruation Disturbances |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D017699 | Pelvic Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D001523 | Mental Disorders |
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