Effect of Auricular Vagus Nerve Stimulation on Pain and Symptoms in Primary Dysmenorrhea
2026년 6월 27일 업데이트: Hüsniye Merve Demirer, Istanbul Gelisim University
The Effect of Transcutaneous Auricular Vagus Nerve Stimulation on Pain, Menstrual Symptoms, Depression, and Anxiety in Young Adults With Primary Dysmenorrhea: A Randomized Single-Blind Controlled Trial
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.
연구 개요
상태
완전한
상세 설명
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.
연구 유형
중재적
등록 (실제)
40
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Avcılar
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Istanbul, Avcılar, 터키 (Türkiye)
- Istanbul Gelisim University
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
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건강한 자원 봉사자를 받아들입니다
아니
설명
Inclusion Criteria:
- Female participants aged 18 years and older
- Diagnosed with primary dysmenorrhea (PD)
- Having regular menstrual cycles within the last 6 months
- Reporting menstrual pain intensity of at least 40 mm on the Visual Analog Scale (VAS)
- Willingness to participate in the study and providing informed consent
Exclusion Criteria:
- Diagnosis of secondary dysmenorrhea
- Irregular menstrual cycles
- Menstrual cycle length shorter than 21 days or longer than 35 days
- History of pregnancy or childbirth, or current pregnancy
- Use of intrauterine device (IUD) or oral contraceptives
- Current use of sedative, analgesic, anti-inflammatory, or psychotropic medication
- History of pelvic surgery or presence of pelvic pathology
- Presence of chronic, systemic, cardiovascular, or neurological diseases (e.g., diabetes mellitus, hypoglycemia, bradycardia, hypotension, hypotonic disorders, etc.)
- Presence of ear implants, ear wounds, or ear infections
- Presence of implanted electronic devices such as pacemakers
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
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디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Transcutaneous auricular vagus nerve stimulation (taVNS)
Transcutaneous auricular vagus nerve stimulation (taVNS) 10 sessions during luteal phase
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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.
다른 이름들:
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가짜 비교기: Sham transcutaneous auricular vagus nerve stimulation
Sham transcutaneous auricular vagus nerve stimulation 10 sessions during luteal phase
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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.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Menstrual pain intensity
기간: 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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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.
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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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Pain threshold
기간: 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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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.
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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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Depression level
기간: 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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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.
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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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Anxiety level
기간: 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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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.
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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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Menstrual symptoms
기간: 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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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.
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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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Premenstrual syndrome severity
기간: 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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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.
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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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Functional and emotional impact of dysmenorrhea
기간: 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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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.
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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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간행물 및 유용한 링크
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일반 간행물
- 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
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2023년 6월 1일
기본 완료 (실제)
2024년 1월 30일
연구 완료 (실제)
2024년 3월 5일
연구 등록 날짜
최초 제출
2026년 5월 4일
QC 기준을 충족하는 최초 제출
2026년 6월 27일
처음 게시됨 (실제)
2026년 7월 6일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 7월 6일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 6월 27일
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2026년 6월 1일
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- 2023-23/113
개별 참가자 데이터(IPD) 계획
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IPD 계획 설명
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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