Ignite Creation Date:
2025-12-24 @ 3:37 PM
Ignite Modification Date:
2025-12-25 @ 8:07 PM
Study NCT ID:
NCT05904392
Status:
COMPLETED
Last Update Posted:
2024-03-05
First Post:
2023-05-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Music Therapy on the Anxiety Level of Patients During the Administration of Ocular Intravitreal Injections
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}, {'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': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2024-02-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-04', 'studyFirstSubmitDate': '2023-05-28', 'studyFirstSubmitQcDate': '2023-06-06', 'lastUpdatePostDateStruct': {'date': '2024-03-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-06-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'STAI', 'timeFrame': 'Just before and immediately after intervention', 'description': 'Change in anxiety score test'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Music therapy', 'anxiety', 'intravitreal injection', 'pain', 'quality of life'], 'conditions': ['Anxiety and Fear']}, 'descriptionModule': {'briefSummary': "Introduction Ocular intravitreal injection is a widely used ophthalmic invasive technique to administer medication directly inside the patient's eye. Despite being usually a quick and painless intervention, some patients report nervousness and anxiety before and during the procedure. Music therapy could help in assessing this discomfort, as previous studies have shown it can beneficial, specially helping to reduce anxiety levels.\n\nObjective This study aims to assess the effect of music therapy on patients undergoing intravitreal injections and how it affects their anxiety.\n\nMethods This is a randomized, prospective, single blind, clinical trial. Patients will be divided into two groups. Group A patients will listen to classical music during the procedure (intervention). Group B patients (control), will not listen to music during the procedure. All other aspects of the procedure will be the same for both groups. To analyze the impact music therapy, patients will fill in the STAI anxiety questionnaire and will be evaluated with the pain visual analogue scale (VAS) before and after the injection procedure.\n\nExpected results Subjects that undergo the procedure with music therapy are expected to experience less anxiety that the ones that do not. Less pain perception is also expected."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients must be at least 18 years old.\n* Patients must have been prescribed an intravitreal injections of an anti-VEGF drug.\n* Subjects must have undergone at least one previous intravitreal injection.\n* Patients must fully understand the procedure and the project they will be participating in and agree on signing the informed consent.\n\nExclusion Criteria:\n\n* Patients with a psychiatric diagnosis with the need to take anxiety medication.\n* Patients that before the intervention took medication to relax, such as benzodiazepines or anxiolytics.\n* Subjects with hearing difficulty.'}, 'identificationModule': {'nctId': 'NCT05904392', 'briefTitle': 'Effect of Music Therapy on the Anxiety Level of Patients During the Administration of Ocular Intravitreal Injections', 'organization': {'class': 'OTHER', 'fullName': 'Althaia Xarxa Assistencial Universitària de Manresa'}, 'officialTitle': 'Effect of Music Therapy on the Anxiety Level of Patients During the Administration of Ocular Intravitreal Injections', 'orgStudyIdInfo': {'id': 'CEI 22/109'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'Music played prior to intravitreal injection', 'interventionNames': ['Other: Music']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'No music played.'}], 'interventions': [{'name': 'Music', 'type': 'OTHER', 'description': 'Music played prior to injection', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08243', 'city': 'Manresa', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Eduard Pedemonte Sarrias', 'geoPoint': {'lat': 41.72815, 'lon': 1.82399}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Althaia Xarxa Assistencial Universitària de Manresa', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Vic - Central University of Catalonia', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD', 'investigatorFullName': 'Eduard Pedemonte-Sarrias', 'investigatorAffiliation': 'Althaia Xarxa Assistencial Universitària de Manresa'}}}}