Ignite Creation Date:
2025-12-26 @ 3:59 PM
Ignite Modification Date:
2025-12-29 @ 6:35 AM
Study NCT ID:
NCT04276506
Status:
COMPLETED
Last Update Posted:
2020-09-28
First Post:
2020-01-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Information Given and Music on the Care of Patient Who Will Undergo Coronary Angiography
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': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 184}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-11-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2020-03-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-09-24', 'studyFirstSubmitDate': '2020-01-27', 'studyFirstSubmitQcDate': '2020-02-17', 'lastUpdatePostDateStruct': {'date': '2020-09-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-01-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'State anxiety level', 'timeFrame': '1 day', 'description': 'Use of the State-Trait Anxiety Inventory (STAI) to assess the level of anxiety'}], 'secondaryOutcomes': [{'measure': 'heart rate', 'timeFrame': '1 day', 'description': 'beats per minute'}, {'measure': 'respiratory rate', 'timeFrame': '1 day', 'description': 'breaths per minute'}, {'measure': 'blood pressure', 'timeFrame': '1 day', 'description': 'mmHg'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Anxiety', 'Coronary Angiography', 'Nursing', 'Music', 'Visual Information', 'Physiological parameters'], 'conditions': ['Anxiety State', 'Invasive Procedure']}, 'descriptionModule': {'briefSummary': "Today, due to the increasing frequency of cardiovascular diseases the number of coronary angiography performed has also risen. This invasive procedure has an effect on patients which causes anxiety. Its important to determine of the level of anxiety so experienced nurses carried out various interventions to reduce anxiety.\n\nThis study aims to determine the effect of listening music and getting information on the level of anxiety and vital signs of the patients who are planned to undergo coronary angiography.\n\nFor this purpose, calming music which is suitable for the heart rhythm and booklets which is prepared with various visuals will be used. In the study, apart from a control group that routine clinical procedures will be applied, there will be two more groups which are called as music and information groups. Patients' participation in these groups will be distributed randomly by computer.", 'detailedDescription': "The patients will be included to this study who will undergo coronary angiography first time and admitted to hospital by appointment.\n\nInserting IV canulla, taking and recording vital signs, and informing about angiography are routine procedures for patients who are admitted to hospital for coronary angiography. These procedures will also be applied to the patient groups involved in the study.\n\nPatients will be assigned to the groups in accordance with the randomization table. After explaining the purpose and method of the study to the patients, their consent will be obtained.In this experimental study all datas will be collected by Descriptive Characteristics Form, Vital Findings Follow-Up Form and The State-Continuity Anxiety Inventory.\n\nVital Signs Follow-Up Form will be recorded according to patients' findings, such as heart rate per minute, blood pressure as mmHg and respiratory rate per minute both before and after angiography.\n\nThe State-Continuity Anxiety Inventory will be applied before angiography to determine the anxiety level of the patients. After the angiography, the state anxiety inventory will be repeated.The information group; A visual information booklet which is prepared by the researcher will be used. In the booklet; Information about coronary arteries, angiography laboratory features, patient preparation procedure and post-procedure are explained with various visuals. The booklet which contains researchers telephone numbers will be given to patients, when they come to hospital to get an angiography appointment. The patients will be asked to read the booklet until the day of angiography. If patients need to ask some questions, they will be able to reach the researchers within specified hours.\n\nThe Music group; A soothing type of music including five kinds sounds of nature which suitable for heart rate was selected and recorded on MP3. When they arrive hospital for angiography they will be explained how to use MP3 player and headset in the room. All music stored on the MP3 player will be played to the patient for five to ten seconds. They will be asked to choose their preferred music. The patient will listen the music which is chosen for 30 minutes via headset. In order to prevent contamination, disposable ear cups will be used for each patient."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adult\n* patients who undergoing coronary angiography first time\n* able to speak and understand turkish\n* people informed clearly by the investigator\n\nExclusion Criteria:\n\n* having any hearing and visual problems\n* being on psychiatric medications\n* emergency cases\n* patient under legally protection'}, 'identificationModule': {'nctId': 'NCT04276506', 'briefTitle': 'Effect of Information Given and Music on the Care of Patient Who Will Undergo Coronary Angiography', 'organization': {'class': 'OTHER', 'fullName': 'Eastern Mediterranean University'}, 'officialTitle': 'Comparison of the Effect of Music and Giving Information on the Patient Care Who Undergoing Coronary Angiography', 'orgStudyIdInfo': {'id': 'EasternMUU'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'information booklet group', 'description': 'information session before the coronary angiography', 'interventionNames': ['Other: information group']}, {'type': 'EXPERIMENTAL', 'label': 'music group', 'description': 'music session before the coronary angiography', 'interventionNames': ['Other: music group']}, {'type': 'NO_INTERVENTION', 'label': 'control group', 'description': 'No information or music session before the coronary angiography'}], 'interventions': [{'name': 'music group', 'type': 'OTHER', 'description': 'to reduce anxiety, some selected music pieces will have patients listened by headset.', 'armGroupLabels': ['music group']}, {'name': 'information group', 'type': 'OTHER', 'description': 'A visual information booklet which is prepared by the researchers will be used', 'armGroupLabels': ['information booklet group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '99628', 'city': 'Famagusta', 'country': 'Cyprus', 'facility': 'EMU Health Science Faculty', 'geoPoint': {'lat': 35.12489, 'lon': 33.94135}}], 'overallOfficials': [{'name': 'Handan Sezgin, Assist Prof.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Eastern Mediterranean University Health Science Faculty'}, {'name': 'Nurdan Yıldız, Msc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Eastern Mediterranean University Health Science Faculty'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eastern Mediterranean University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}