Ignite Creation Date:
2025-12-24 @ 5:09 PM
Ignite Modification Date:
2025-12-27 @ 1:33 AM
Study NCT ID:
NCT06790550
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-01-28
First Post:
2025-01-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Music Effect on the Self-Injection, Testing Fear and Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009147', 'term': 'Music Therapy'}], 'ancestors': [{'id': 'D026421', 'term': 'Sensory Art Therapies'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'They do not know the experimental or control procedures that take place'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'study group and control group'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-01-30', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2025-07-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-24', 'studyFirstSubmitDate': '2025-01-18', 'studyFirstSubmitQcDate': '2025-01-18', 'lastUpdatePostDateStruct': {'date': '2025-01-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual Analogue Scale', 'timeFrame': 'Before insulin administration on day, Time Frame: After two insulin administration on the second day', 'description': 'The scale is used to assess subjectively perceived pain. It is a 10 cm (100 mm) ruler with no pain on one end and the "most severe pain" on the other. The individuals participating in the study are asked to mark the intensity of pain they are currently feeling, explaining that the number "0" on the scale means "I feel no pain" and that the intensity of pain increases as the numbers increase, and the number "10" means "I feel the most severe pain". An increase in the score obtained from the scale in the assessment indicates that the pain is increasing. Each patient will be administrated three times.'}], 'secondaryOutcomes': [{'measure': 'Diabetes Fear of Self Injecting and Self-testing Questionnaire', 'timeFrame': 'Before insulin administrated on day one, Time Frame: After two insulin administration on the second day.', 'description': 'Questionnaire measures fear of self-injection and testing in diabetic individuals who require insulin. Questionnaire, which contains 15 statements, consists of two sub-dimensions: fear of self-injecting (6 statements) and fear of self-testing (9 statements). Each statement has a four-point Likert-type scoring ranging from 0 to 3 (0= almost never, 1= sometimes, 2= often, 3= almost always). The evaluation of the questionnaire form can be done by taking the average or raw score for the two sub-dimensions and the entire form. When taken as raw score, self-injection fear score varies between 0-18, self-testing fear score between 0-27, and total fear score between 0-45. Increasing score indicates increasing fear. Each patient will be administrated three times.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['type 2 diabetes mellitus', 'Insulin', 'fear', 'pain', 'insulin injection', 'music'], 'conditions': ['Type 2 Diabetes Mellitus (T2DM)', 'Insulin', 'Fear', 'Pain', 'Injection', 'Music Therapy']}, 'descriptionModule': {'briefSummary': 'Diabetes is a chronic and broad-spectrum metabolic disorder characterized by hyperglycemia that occurs due to relative or absolute insulin deficiency or "insulin resistance" developed against insulin action in peripheral tissues, affecting many organs and causing multisystem involvement. Metabolic function continues to deteriorate after diagnosis, leading to worsening glycemic control and insulin therapy becoming necessary. However, patients may have difficulty adhering to insulin therapy. Fears about injections are common in both adults and children and, as research shows, are a major reason why people with diabetes avoid taking insulin. Addressing these fears is an important part of helping patients reduce their risk of diabetes-related complications. Helping patients manage their replacement pain may help reduce the effects of needle fear in the future. There are a number of strategies that can ease the pain.The use of music in pain management has advantages such as being reliable, cheap, and having no side effects, as well as reducing postoperative pain reports. Music distracts the individual from negative stimuli and allows them to focus on something they enjoy, thus reducing pain and anxiety. Music therapy has also been shown to have sedative-protective effects and reduce stress hormone levels. Listening to preferred music can distract and reduce the pain and negative emotions associated with an unpleasant experience.', 'detailedDescription': 'Research Type:\n\nThe research will be conducted as a randomized controlled experimental model.\n\nResearch Universe and Sample:\n\nThe research sample will consist of patients diagnosed with Type 2 Diabetes hospitalized in a State Hospital. The sample of the research is expected to consist of 100 volunteer Type 2 Diabetes patients who applied to the State Hospital.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '15 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Type 2 diabetes for at least one year\n* Self-administering insulin injection\n* Self-administering glucometer, insulin pen or insulin pump\n\nExclusion Criteria:\n\n* poor mental health\n* Having gestational diabetes mellitus or Type 1 diabetes\n* no hearing problems'}, 'identificationModule': {'nctId': 'NCT06790550', 'briefTitle': 'Music Effect on the Self-Injection, Testing Fear and Pain', 'organization': {'class': 'OTHER', 'fullName': 'Dicle University'}, 'officialTitle': "Examination of Music's Demonstration to Self-Injection, Fear of Testing and Pain in Patients With Type 2 Diabetes", 'orgStudyIdInfo': {'id': 'DICLE-ARDASURUCU-002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Music group', 'description': 'Music will be played during the insulin injection process', 'interventionNames': ['Other: Music Therapy']}, {'type': 'NO_INTERVENTION', 'label': 'Control group (Music free)', 'description': 'patients without of experimental Music'}], 'interventions': [{'name': 'Music Therapy', 'type': 'OTHER', 'description': 'Music will be played during the insulin injection process', 'armGroupLabels': ['Music group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21100', 'city': 'Diyarbakır', 'state': 'South East', 'country': 'Turkey (Türkiye)', 'facility': 'Dicle Univertsity', 'geoPoint': {'lat': 37.91363, 'lon': 40.21721}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dicle University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PROFESSOR', 'investigatorFullName': 'Hamdiye ARDA SÜRÜCÜ', 'investigatorAffiliation': 'Dicle University'}}}}