Clinical Research Directory

Transcutaneous Cervical Vagus Nerve Stimulation for Primary Dysmenorrhea

This randomized, sham-controlled, parallel-group clinical trial will investigate the effects of bilateral transcutaneous cervical vagus nerve stimulation (tcVNS) on menstrual pain and related clinical outcomes in women with primary dysmenorrhea. Seventy women aged 18-30 years will be randomly allocated in a 1:1 ratio to either active tcVNS or sham stimulation. The intervention will be administered once daily for 8 minutes during the first three days of menstruation. Outcomes will include menstrual pain intensity, multidimensional pain characteristics, dysmenorrhea-related functional and emotional symptoms, anxiety and depression, menstrual symptoms, analgesic use, and heart rate variability. Participants will be followed for five days during one menstrual cycle.

Effect of Virtual Reality on Pain and Anxiety in Women With Dysmenorrhea

Dysmenorrhea, or painful menstrual periods, is a common condition that can affect daily activities and quality of life. This study aims to evaluate whether using virtual reality (VR) can reduce pain and anxiety in women with primary dysmenorrhea. Participants will be randomly assigned to either a VR group or a 2D video group. Participants in the VR group will watch a relaxing virtual environment using a VR headset for 20 minutes once a day for three consecutive days. Participants in the 2D video group will watch the same content for the same duration and frequency using a 2D screen, such as a phone, tablet, or computer. Pain intensity and anxiety levels will be assessed before and after each session during the three-day intervention. The study will compare changes in pain and anxiety between the two groups to evaluate the effect of VR in women with primary dysmenorrhea.

Vaginal Sildenafil for Primary Dysmenorrhea

This open-label, non-randomized mechanistic study will evaluate whether a single 100 mg vaginal sildenafil citrate suppository reduces uterine hypercontractility during menstruation in adults with moderate-to-severe dysmenorrhea. Ten participants will each receive one open-label dose during a single menstrual treatment visit and will serve as their own control: 6 participants with primary dysmenorrhea and no evidence of pelvic pathology, plus a separately analyzed exploratory subset of 4 participants, 2 with known endometriosis and 2 with known uterine fibroids. Uterine contractility will be measured with cine magnetic resonance imaging (MRI) before dosing and approximately 4 hours after dosing. Additional objectives are to evaluate acute menstrual pain over the 4-hour observation window, to document systemic exposure using sparse plasma sampling at approximately 2 and 4 hours after dosing, and to assess short-term safety and local tolerability.

Non-Steroidal Anti-Inflammatory Drug (NSAID) Response and Central Sensitization of Pain in Women With Dysmenorrhea

Menstrual pain is the most common gynecological complaint and the leading cause of school and work absences in reproductive-age girls and women. One of the primary treatments for menstrual pain is use of nonsteroidal anti-inflammatory drugs (NSAIDs; over-the-counter medications such as naproxen, ibuprofen, or aspirin), although up to 18% of women do not get pain relief from these medications. One reason for this may be due to central sensitization of pain, which is when alterations in the central nervous system change how pain is processed in the brain and experienced. Determining the role of central sensitization in menstrual pain is important because central sensitization is associated with the development of chronic pain. Understanding the relationship between NSAID response and central sensitization is important because it could indicate women who may go on to develop chronic pain later in life. This study would directly address this question. Identifying women at risk for chronic pain would help target new treatments to this vulnerable group to ideally prevent pain from becoming chronic. This is particularly important for women in the military because the severity of menstrual pain is associated with missed work, such that in active-duty military women, less than 4.4% with mild menstrual pain missed work, whereas 20.7% of women with moderate to severe menstrual pain missed work. Addressing the significant impact of menstrual pain for military women will help reducing suffering and potentially decrease the risk of developing future chronic pain problems in this population.

Self-Acupressure for Primary Dysmenorrhea and Premenstrual Symptoms

This randomized, sham-controlled trial aims to evaluate the effects of self-administered acupressure on menstrual pain severity and premenstrual symptoms in women aged 18-30 years with primary dysmenorrhea. Participants will be randomly assigned to either a self-acupressure intervention group or a sham self-acupressure control group. The intervention will be applied during the premenstrual and menstrual periods over approximately six months. The primary outcome is the change in menstrual pain severity, and secondary outcomes include changes in premenstrual symptom severity, analgesic use, and menstruation-related activity limitation.

A Clinical Study to Assess the Effect of a Dietary Supplement on Menstrual Cycle Symptoms

This is a single-group, virtual clinical trial evaluating the effects of a daily dietary supplement (DITTO Cycle Supplement) on menstrual cycle symptoms across three menstrual cycles. The study investigates changes in symptom severity through validated questionnaires including the Menstrual Symptoms Questionnaire (MSQ), and proportion of participants experiencing symptom reduction.

The Good Pain Consultation in Endometriosis.

This PhD project investigates the effect of "the good pain consultation" and early integration of biopsychosocial pain education with current standard management of endometriosis. Our goal is to facilitate self-management of pain and improve health-related quality of life (HRQOL) using limited resources. Our research question is: Does a good pain consultation improve pain self-efficacy and HRQOL, compared to usual care at 3 months and 1 year.? Researchers will compare a good pain consultation to a control group that will receive usual care. Participants will: Attend a consultation and biopsychososial pain education plus usual care or usual care alone. They will answer questions in an internet-based questionnaires three times point during the study.

High-Intensity Interval Training and Menstrual Health Experience in Primary Dysmenorrhea.

The goal of this study is to evaluate whether a 12-week online supervised high-intensity interval training program can reduce menstrual pain and improve quality of life in women with primary dysmenorrhea. Participants will be divided into two groups: one receiving an educational workshop and the HIIT program, and a control group receiving only the workshop. Additionally, the study seeks to understand the personal experience of these women through weekly health diaries, exploring how the intervention affects their relationship with their bodies and their menstruation. The ultimate goal is to offer new, non-pharmacological evidence-based tools for managing menstrual pain.

TENS for Primary Dysmenorrhea

Primary dysmenorrhea is a common gynecological condition characterized by recurrent menstrual pain in the absence of pelvic pathology. It affects a large proportion of women of reproductive age and may significantly interfere with daily activities, academic performance, and quality of life. Although pharmacological treatments such as nonsteroidal anti-inflammatory drugs are frequently used to manage menstrual pain, some women experience insufficient relief or prefer non-pharmacological treatment options. Transcutaneous electrical nerve stimulation (TENS) is a non-invasive electrotherapy technique widely used in pain management. TENS is thought to reduce pain through mechanisms including modulation of nociceptive transmission at the spinal cord level and activation of endogenous analgesic pathways. Portable TENS devices may provide a convenient and accessible option for self-management of menstrual pain. The aim of this randomized controlled pilot study was to evaluate the effectiveness of a portable TENS device in reducing pain intensity in women with primary dysmenorrhea. Participants diagnosed with primary dysmenorrhea were randomly assigned to either an intervention group receiving treatment with a portable TENS device or a control group receiving usual care. The intervention consisted of the application of a portable TENS patch to the lower abdominal region during menstrual pain episodes. The device delivered alternating stimulation cycles combining high-frequency stimulation (85 Hz) and burst stimulation (2 Hz). Each treatment session lasted approximately 20 minutes and was applied during menstrual pain episodes. Participants were followed for up to three menstrual cycles. Pain intensity was assessed using a visual analogue scale (VAS). Additional outcomes included quality of life assessed using the Short Form-12 Health Survey (SF-12), anxiety and depression measured with the Hospital Anxiety and Depression Scale (HADS), female sexual function evaluated with the Female Sexual Function questionnaire (FSM), and analgesic medication use recorded in a pain diary. The results of this study aim to contribute to the evidence on non-pharmacological interventions for menstrual pain and to evaluate the potential role of portable TENS devices as a safe and accessible option for women with primary dysmenorrhea.

A Research Study Exploring How Musculoskeletal Function and the Autonomic Nervous System Relate to Visceral Pain in Women With and Without Dysmenorrhea (Painful Periods).

The purpose of this clinical trial is to determine if women with dysmenorrhea demonstrate an increased musculoskeletal and autonomic nervous system response to a painful visceral stimulus compared to controls. A secondary aim is to determine if interoceptive awareness moderates this relationship. The designed methodology aims to elucidate the intricate connections between the interoceptive and musculoskeletal systems in pain perception among female participants, providing valuable insights into the underlying mechanisms of interoceptive pain and functional musculoskeletal changes.

An Open-Label Study to Evaluate the Effect of Elix Cycle Balance & Elix Daily Harmony on Fibroid-related Symptoms

This is a 24-week, single-arm, open-label, virtual study evaluating the effects of Elix Cycle Balance and Elix Daily Harmony on uterine fibroid-related symptoms and quality of life in 42 participants. Participants will self-administer the investigational herbal supplements daily and complete validated questionnaires at scheduled timepoints to assess symptom severity and quality of life.

Abdominal Muscle Strengthening for Menstrual Symptoms in Primary Dysmenorrhea

This randomized controlled trial aims to investigate the effects of abdominal muscle strengthening exercises using a stabilizer pressure biofeedback device on menstrual symptoms and abdominal muscle strength in young women with primary dysmenorrhea. Primary dysmenorrhea, characterized by painful menstrual cramps without underlying pelvic pathology, is common among women of reproductive age and can negatively affect quality of life. In this study, 58 female participants aged 18-25 with regular menstrual cycles and a Visual Analog Scale (VAS) pain score of ≥4 will be randomly assigned to either an intervention group or a control group. The intervention group will perform abdominal strengthening and stretching exercises guided by a stabilizer pressure biofeedback device, three times per week for 6 weeks (excluding menstruation weeks). The main outcomes include menstrual symptom severity (assessed by the Menstrual Symptom Scale), pain intensity (VAS), and abdominal muscle strength (measured using the stabilizer pressure biofeedback device). The results will help determine whether targeted abdominal muscle training can reduce menstrual symptoms and improve muscle strength in women with primary dysmenorrhea.

Effect of Myofascial Release on Menstrual Pain Post Caesarean Section

The purpose of this study is to investigate the effect of myofascial release on menstrual pain post cesarean section.

Menstrual Complaints in Adolescents and Adults

The aim of this study is to investigate the prevalence of menstrual complaints and their impact on daily life activities (school/work absence, absence from social activities, sports) in adults and adolescents.