Ignite Creation Date:
2025-12-24 @ 1:03 PM
Ignite Modification Date:
2026-01-04 @ 1:20 PM
Study NCT ID:
NCT06389461
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-29
First Post:
2024-04-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
4th Ventricular Compression Technique on Anxiety
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001008', 'term': 'Anxiety Disorders'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-09-16', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-26', 'studyFirstSubmitDate': '2024-04-16', 'studyFirstSubmitQcDate': '2024-04-26', 'lastUpdatePostDateStruct': {'date': '2024-04-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in anxiety levels through the STAI (The State-Trait Anxiety Inventory) questionnaire score on the 1st and last intervention.', 'timeFrame': 'One week after the last intervention', 'description': 'The participants were submitted to a evaluation 1 week prior the 1st and 1 week after the last intervention. The corresponding questionnaires were sent to the researchers so that they could record the information. Quoted with a min. of 20 points and a max. of 80 - higher the score worst level of anxiety.'}], 'secondaryOutcomes': [{'measure': 'Change from baseline in thoraco-abdominal perimetry on the 1st and last intervention', 'timeFrame': 'Immediately after last intervention', 'description': 'The participants were submitted to a evaluation/ measurement in the 1st and last intervention. The corresponding results were registered by the researchers so that they could record the information.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Anxiety', 'College Students', 'CV4', 'Osteopathic treatment'], 'conditions': ['Healthy']}, 'referencesModule': {'availIpds': [{'url': 'https://doi.org/10.1590/S1516-44462000000600006', 'type': 'Castilloa, A. R. G. L., Recondob, R., Asbahrc, F. R. & Manfrod, G. G. (2000).', 'comment': 'Transtornos de ansiedade. Revista Brasileira de Psiquiatria. 22(2), 20-23.'}, {'url': 'http://doi.org/10.1016/j.jbmt.2020.07.017', 'type': 'Abenavoli, A., Badi, F., Barbieri, M., Bianchi, M., Biglione, G., Dealessi, C., Grandini, M., Lavazza, C., Mapelli, L., Milano, V., Monti, L., Seppia, S., Tresoldi, M. & Maggiani, A. (2020).', 'comment': 'Cranial osteopathic treatment and stress-related effects on autonomic nervous system measured by salivary markers: A pilot study. Journal of Bodywork and Movement Therapies. 24(4), 215-221.'}]}, 'descriptionModule': {'briefSummary': 'Determinate the effects of the technique of 4th ventricle in college students with anxiety, applying the technique one time per week during three weeks.', 'detailedDescription': 'The anxiety is a warning sign that makes it possible for the individual to defend themselves and protect themselves from threats. This is considered a natural and necessary reaction for self-preservation. However, when it appears persistently, exaggeratedly or disproportionately in relation to a stimulus, the following are considered: pathological anxiety.\n\nThe compression of the fourth ventricle (CV4) is one of the most well-known procedures in the practice of cranial manipulation. It is also one of the most clinically tested techniques and has been postulated to be associated with decreased sympathetic tone.\n\nTherefore, this was the chosen technique, as it significantly affects the relaxation of the SNS tonus and, thereafter, anxiety.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '25 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ages between 18 and 25 years old;\n* Be a college/university student;\n* Not have knowledge of the technique used;\n* Achieve a 20 plus score on the State-Trait Anxiety Inventory questionnaire.\n\nExclusion Criteria:\n\n* Use of pharmacological therapy for psychological disorders;\n* Presence of conditions that prevent or contraindicate the technique, including tumors, fractures, dislocations, vertebrobasilar insufficiency, bone diseases, neurological diseases, fever, skin diseases, cardiovascular diseases, psychiatric diseases, increased intracranial pressure.\n* Surgeries or traumas in the specific areas of the technique;\n* Pregnancy;\n* Osteopathic treatments or other manual therapies aimed at reducing anxiety;\n* Evident postural alteration or deformity of the thoracic cage.'}, 'identificationModule': {'nctId': 'NCT06389461', 'briefTitle': '4th Ventricular Compression Technique on Anxiety', 'organization': {'class': 'OTHER', 'fullName': 'Escola Superior de Tecnologia da Saúde do Porto'}, 'officialTitle': 'The Efficacy of the 4th Ventricular Compression Technique on Anxiety in Students: RCT', 'orgStudyIdInfo': {'id': 'OST1_012'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '4th Ventricular Compression Technique', 'description': 'The technique was preformed by the investigator during 5 minutes.', 'interventionNames': ['Other: 4th Ventricular Compression Technique']}, {'type': 'PLACEBO_COMPARATOR', 'label': '"Sham" Therapy', 'description': 'The technique was preformed by the investigator during 5 minutes.', 'interventionNames': ['Other: "Sham" Therapy']}], 'interventions': [{'name': '4th Ventricular Compression Technique', 'type': 'OTHER', 'description': "The investigator who applied the technique stood on top of the headboard of the table, with feet flat on the floor, at an appropriate level in relation to the volunteer's headboard.\n\nThe investigator joins hands in a cupping position, with the pads of the 1st fingers forming a triangle. The pads of the 1st fingers make contact with the spinous processes of the 2nd and 3rd cervical vertebrae. The thenar eminences make contact with the occipital squama, avoiding contact with the occipito-mastoid sutures during 5 minutes.\n\nA second Investigator was sitting on a chair, placed on the opposite side of the head of the table with a stopwatch in his dominant hand, in order to time the application time of each technique.", 'armGroupLabels': ['4th Ventricular Compression Technique']}, {'name': '"Sham" Therapy', 'type': 'OTHER', 'description': "The investigator who applied the technique stood on top of the headboard of the table, with feet flat on the floor, at an appropriate level in relation to the volunteer's headboard.\n\nThe investigator places hands on the patient's shoulders during 5 minutes. A second Investigator was sitting on a chair, placed on the opposite side of the head of the table with a stopwatch in his dominant hand, in order to time the application time of each technique.", 'armGroupLabels': ['"Sham" Therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4200-072', 'city': 'Porto', 'country': 'Portugal', 'facility': 'Escola Superior da Saúde do Porto', 'geoPoint': {'lat': 41.1485, 'lon': -8.61097}}], 'centralContacts': [{'name': 'Natália MO Campelo, PhD', 'role': 'CONTACT', 'email': 'nmc@ess.ipp.pt', 'phone': '22 206 1000'}, {'name': 'Natália MO Campelo', 'role': 'CONTACT', 'email': 'nmc@ess.ipp.pt', 'phone': '22 206 1000'}], 'overallOfficials': [{'name': 'Natália MO Natália', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Escola Superior da Saúde do Porto'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Escola Superior de Tecnologia da Saúde do Porto', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Natália Maria Oliveira Campelo', 'investigatorAffiliation': 'Escola Superior de Tecnologia da Saúde do Porto'}}}}