Ignite Creation Date:
2025-12-24 @ 2:56 PM
Ignite Modification Date:
2025-12-26 @ 10:43 PM
Study NCT ID:
NCT06741059
Status:
RECRUITING
Last Update Posted:
2025-03-20
First Post:
2024-12-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of TENS on Pain and Symptoms in Primary Dysmenorrhea
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004412', 'term': 'Dysmenorrhea'}], 'ancestors': [{'id': 'D008599', 'term': 'Menstruation Disturbances'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D017699', 'term': 'Pelvic Pain'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': "Study Design: This study follows a parallel design with three groups:\n\nExperimental Group: Participants in this group receive the active intervention (e.g., Transcutaneous Electrical Nerve Stimulation - TENS).\n\nPlacebo Group: Participants in this group receive a placebo treatment (e.g., a sham TENS treatment or a non-active intervention).\n\nControl Group: Participants in this group receive no intervention or the standard treatment.\n\nBlinding: A single-blind design is used in this study, meaning only the participants do not know which group they are assigned to. The research team is aware of the group assignments. This approach helps prevent the participants' expectations from influencing the results."}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This design allows for direct comparison of the active intervention, placebo, and no intervention (control), evaluating the impact of the treatment on the outcomes.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 93}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-12-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2025-05-25', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-17', 'studyFirstSubmitDate': '2024-12-16', 'studyFirstSubmitQcDate': '2024-12-16', 'lastUpdatePostDateStruct': {'date': '2025-03-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-12-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Transcutaneous Electrical Nerve Stimulation', 'timeFrame': '3 months', 'description': 'Transcutaneous Electrical Nerve Stimulation (TENS) is effective in pain management in women with primary dysmenorrhea. The Visual Analog Scale is a scale where the patient can mark their own pain on a ruler that can be used horizontally or vertically, where the pain is evaluated between 0-10. VCS is used to evaluate both the severity of pain and the effectiveness of the treatment/intervention on pain in various populations. An increase in the score indicates an increase in pain.'}], 'secondaryOutcomes': [{'measure': 'Transcutaneous Electrical Nerve Stimulation (TENS) is effective in managing menstrual symptoms in women with primary dysmenorrhea.', 'timeFrame': '3 months', 'description': 'Transcutaneous Electrical Nerve Stimulation (TENS) is effective in managing menstrual symptoms in women with primary dysmenorrhea.A scale was developed by Taylor in 1979 to assess the symptoms and intensity of symptoms that occur during menstruation. The Turkish validity and reliability of the scale was performed by Oskay et al. in 2008. The scale, which contains seventeen items, has no sub-dimensions with each symptom being scored between 0 and 5. An increase in score indicates an increase in the intensity of the symptoms'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Primary Dysmenorrhea', 'Transcutaneous Electric Nerve Stimulation', 'Menstrual Pain', 'nursing'], 'conditions': ['Dysmenorrhea']}, 'descriptionModule': {'briefSummary': 'The Effect of Transcutaneous Electrical Nerve Stimulation (TENS) on Pain and Menstrual Symptoms in Primary Dysmenorrhea\n\nThis study aims to investigate the effectiveness of Transcutaneous Electrical Nerve Stimulation (TENS) in managing pain and alleviating menstrual symptoms in individuals with primary dysmenorrhea. Primary dysmenorrhea is characterized by severe menstrual pain and accompanying symptoms that negatively impact the quality of life and daily functioning. TENS, a non-invasive and drug-free method, is applied to relieve pain by stimulating nerves through electrical impulses. This research evaluates the impact of TENS on both the intensity of menstrual pain and associated symptoms, offering insights into its potential as an alternative or complementary therapeutic approach.', 'detailedDescription': "The Effect of Transcutaneous Electrical Nerve Stimulation (TENS) on Pain and Menstrual Symptoms in Primary Dysmenorrhea\n\nPrimary dysmenorrhea is a common health problem experienced by women during their menstrual periods, significantly affecting their quality of life. It is often characterized by severe abdominal pain, cramp-like symptoms, nausea, headaches, and fatigue. These symptoms can impact social and functional activities, and in some cases, restrict participation in daily routines.\n\nThe treatment of primary dysmenorrhea aims to alleviate symptoms and help women experience a more comfortable menstrual period. Traditional treatments include pain relievers, hormonal therapies, and lifestyle changes. However, these methods may not always be sufficient, or some women may avoid them due to potential side effects.\n\nTranscutaneous Electrical Nerve Stimulation (TENS) has gained popularity in recent years as a non-invasive method for pain management. TENS works by modulating nerve stimulation through low-frequency electrical currents applied to the skin, reducing pain perception. Its potential effectiveness in alleviating menstrual pain has drawn increasing attention as an alternative treatment option.\n\nThis study aims to evaluate the effects of TENS on pain and menstrual symptoms in women with primary dysmenorrhea. The research will assess the potential of TENS to reduce menstrual pain and compare its effectiveness with other treatment options. If TENS proves to be effective in managing dysmenorrhea symptoms, it could enhance women's quality of life and provide a valuable non-pharmacological treatment alternative.\n\nThe findings of this study could contribute to understanding the role of TENS in alleviating dysmenorrhea symptoms and developing effective treatment strategies to improve women's quality of life during their menstrual periods."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Women', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged 18 and above\n* Have regular menstrual cycles (lasting 3 to 8 days, with a menstrual cycle range of 21 to 35 days)\n* Have dysmenorrhea pain severity rated 4 or higher on the Visual Analog Scale (VAS)\n\nExclusion Criteria: Women with the following conditions were excluded from the study:\n\n* Secondary dysmenorrhea\n* Using oral contraceptives\n* Having impaired tissue integrity in the abdominal area\n* Having previous experience with TENS\n* Having a history of nerve damage or sensory loss\n* Having a pacemaker\n* Having any systemic diseases\n* Being pregnant or in the postpartum period'}, 'identificationModule': {'nctId': 'NCT06741059', 'briefTitle': 'Effect of TENS on Pain and Symptoms in Primary Dysmenorrhea', 'organization': {'class': 'OTHER', 'fullName': 'Osmaniye Korkut Ata University'}, 'officialTitle': 'Determining the Effect of Transcutaneous Electrical Nerve Stimulation (TENS) on Pain and Menstrual Symptoms in Primary Dysmenorrhea', 'orgStudyIdInfo': {'id': 'OKU-SBF-EU-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'The group receiving the TENS treatment', 'description': 'The group has received the TENS treatment.', 'interventionNames': ['Other: Transkutanöz Elektriksel Sinir Stimülasyonu - TENS']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Comparator', 'description': 'It is the placebo group where the TENS device is applied, but no treatment is given.', 'interventionNames': ['Other: Transkutanöz Elektriksel Sinir Stimülasyonu - TENS']}, {'type': 'NO_INTERVENTION', 'label': 'Control Group', 'description': 'It is the control group, which receives no intervention or standard treatment.'}], 'interventions': [{'name': 'Transkutanöz Elektriksel Sinir Stimülasyonu - TENS', 'type': 'OTHER', 'description': 'Transcutaneous Electrical Nerve Stimulation (TENS) has gained popularity in recent years as a non-invasive method for pain management. TENS works by modulating nerve stimulation through low-frequency electrical currents applied to the skin, reducing pain perception. Its potential effectiveness in alleviating menstrual pain has drawn increasing attention as an alternative treatment option', 'armGroupLabels': ['Placebo Comparator', 'The group receiving the TENS treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80010', 'city': 'Osmaniye', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Kadir Dündar', 'role': 'CONTACT'}], 'facility': 'Esra Ünal', 'geoPoint': {'lat': 37.07417, 'lon': 36.24778}}], 'centralContacts': [{'name': 'Esra U Unal, Doctor', 'role': 'CONTACT', 'email': 'esraunal2428@gmail.com', 'phone': '+905342878405'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'I will share the study results, but individual forms will not be shared because they require patient consent.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Osmaniye Korkut Ata University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr', 'investigatorFullName': 'ESRA ÜNAL', 'investigatorAffiliation': 'Osmaniye Korkut Ata University'}}}}