Ignite Creation Date:
2025-12-24 @ 2:35 PM
Ignite Modification Date:
2026-01-06 @ 9:58 PM
Study NCT ID:
NCT07268859
Status:
RECRUITING
Last Update Posted:
2025-12-08
First Post:
2025-06-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Fan Application in Preventing Ticagrelor-Associated Dyspnea
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054058', 'term': 'Acute Coronary Syndrome'}, {'id': 'D004417', 'term': 'Dyspnea'}], 'ancestors': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C467559', 'term': 'CCP110 protein, human'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-07-18', 'size': 193427, 'label': 'Study Protocol: Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-11-10T05:46', 'hasProtocol': True}, {'date': '2025-07-18', 'size': 187387, 'label': 'Study Protocol and Statistical Analysis Plan: Ethics Approval', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-11-10T07:28', 'hasProtocol': True}, {'date': '2025-07-18', 'size': 188801, 'label': 'Informed Consent Form: Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_002.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2025-11-10T05:46', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'Outcomes will be assessed by a statistician not involved in the study. Participants and researchers will not be blinded due to the nature of the intervention.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants will be randomized into two groups: control and experimental. Randomization will be computer-based. Data will be analyzed by a statistician not involved in the study.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 110}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-03-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2026-01-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-04', 'studyFirstSubmitDate': '2025-06-18', 'studyFirstSubmitQcDate': '2025-12-04', 'lastUpdatePostDateStruct': {'date': '2025-12-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-01-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Severity of ticagrelor-associated dyspnea', 'timeFrame': 'Time Frame: 0-120 minutes after ticagrelor administration (T1: baseline; T2: 30 min; T3: 60 min; T4: 120 min) Unit of Measure: Score (0-10)', 'description': 'Dyspnea severity will be assessed using the Modified Borg Dyspnea Scale (0-10) at T1 (baseline), T2 (30 min), T3 (60 min), and T4 (120 min) after ticagrelor administration. Higher scores indicate greater symptom severity.'}], 'primaryOutcomes': [{'measure': 'Incidence of ticagrelor-associated dyspnea', 'timeFrame': 'Time Frame: 0-120 minutes after ticagrelor administration (T1: baseline; T2: 30 min; T3: 60 min; T4: 120 min) Unit of Measure: Percentage of participants (%)', 'description': 'The proportion of participants who experience dyspnea within 120 minutes following ticagrelor administration will be recorded.'}], 'secondaryOutcomes': [{'measure': 'Time to onset of ticagrelor-associated dyspnea', 'timeFrame': 'Time Frame: Within 120 minutes after ticagrelor administration (T1-T4) Unit of Measure: Minutes (min)', 'description': 'The time interval between ticagrelor administration and the first reported dyspnea episode will be measured in minutes.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Nursing', 'Ticagrelor', 'Hand fan therapy', 'Dyspnea', 'Non-pharmacological intervention'], 'conditions': ['Acute Coronary Syndromes', 'Ticagrelor', 'Dyspnea']}, 'descriptionModule': {'briefSummary': 'This study will be conducted in the coronary intensive care unit of Dr. Siyami Ersek Chest, Heart and Vascular Surgery Training and Research Hospital. It aims to investigate the effect of hand fan therapy on ticagrelor-associated dyspnea in patients receiving ticagrelor.', 'detailedDescription': 'Patients in the coronary intensive care unit receiving ticagrelor and meeting the inclusion criteria will be included. The study includes two groups: a control group receiving standard care and an experimental group receiving standard care plus hand fan therapy. A total of 110 participants (55 per group) will be recruited. Randomization will be performed using a computer-based randomization program. Due to the nature of the intervention and sample characteristics, participants and the researcher will not be blinded. Data will be analyzed by a statistician not involved in the study, and the findings will be reported.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Between the ages of 18 and 65,\n* No severe hearing and vision problems,\n* Can speak and understand Turkish,\n* Easy to communicate with,\n* First-time sufferer of acute coronary syndrome (ACS) for the first time,\n* Decided to start ticagrelor therapy,\n* Able to adapt to treatment,\n* Individuals who volunteered to participate in the research.\n\nExclusion Criteria:\n\n* Having any problem that prevents you from communicating cognitively, emotionally and verbally,\n* Obstructive sleep abnormalities,\n* Have a disease that affects respiratory function (stage IV cancer, bronchial asthma, COVID-19, lung cancer, pulmonary edema, chronic obstructive pulmonary disease, pulmonary hypertension, pulmonary embolism, pneumonia or bronchitis, etc.),\n* With metabolic abnormalities,\n* Intubated after the procedure,\n* Previously treated with ticagrelor,\n* Individuals who did not volunteer to participate in the study. Losses to follow up\n* Individuals who wish to leave the study voluntarily.\n* Saturation value below 95%,\n* The one with the arrest,\n* Who will not be able to fulfill the requirements of the work,\n* Individuals with life-threatening conditions'}, 'identificationModule': {'nctId': 'NCT07268859', 'acronym': 'ACS', 'briefTitle': 'Effect of Fan Application in Preventing Ticagrelor-Associated Dyspnea', 'organization': {'class': 'OTHER', 'fullName': 'Acibadem University'}, 'officialTitle': 'Effect of Fan Application in Preventing Ticagrelor-associated Dyspnea in Patients With Acute Coronary Syndrome.', 'orgStudyIdInfo': {'id': 'ATADEK2024-10/449'}, 'secondaryIdInfos': [{'id': 'Is an identifier other', 'type': 'OTHER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Standard Care (Control Group)', 'description': 'Routine ward care including semi-Fowler position and breathing exercises. Standard institutional care will be applied. Presence, number, and severity of dyspnea attacks will be recorded during the first 2 hours after ticagrelor administration.', 'interventionNames': ['Other: STANDART CARE']}, {'type': 'EXPERIMENTAL', 'label': 'Standard Care + Fan Therapy (Experimental Group)', 'description': "In addition to standard care, patients will undergo hand fanning for 5 minutes at 30, 60, and 120 minutes after ticagrelor administration. The fan will be directed toward the patient's face from a distance of \\~15 cm. Dyspnea severity and number of episodes will be recorded during this period.\n\nDevice: Hand Fan", 'interventionNames': ['Other: STANDART CARE & FAN THERAPY']}], 'interventions': [{'name': 'STANDART CARE', 'type': 'OTHER', 'description': 'Routine ward care including semi-Fowler position and breathing exercises. Standard institutional care will be applied. Presence, number, and severity of dyspnea attacks will be recorded during the first 2 hours after ticagrelor administration.', 'armGroupLabels': ['Standard Care (Control Group)']}, {'name': 'STANDART CARE & FAN THERAPY', 'type': 'OTHER', 'otherNames': ['Fan'], 'description': "In addition to standard care, patients will undergo hand fanning for 5 minutes at 30, 60, and 120 minutes after ticagrelor administration. The fan will be directed toward the patient's face from a distance of \\~15 cm. Dyspnea severity and number of episodes will be recorded during this period.", 'armGroupLabels': ['Standard Care + Fan Therapy (Experimental Group)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34320', 'city': 'Istanbul', 'state': 'Avcılar', 'status': 'NOT_YET_RECRUITING', 'country': 'Turkey (Türkiye)', 'facility': 'İstanbul Üniversitesi-Cerrahapaşa', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}, {'zip': '34668', 'city': 'Istanbul', 'state': 'Üsküdar', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'facility': 'Sağlık Bilimleri Üniversitesi Dr. Siyami Ersek Göğüs Kalp ve Damar Cerrahisi Eğitim Araştırma Hastanesi', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'centralContacts': [{'name': 'Emine Tuğba YORULMAZ, research assistant', 'role': 'CONTACT', 'email': 'tugbayoorlmz@gmail.com', 'phone': '+905556177281'}, {'name': 'Arzu ERKOÇ, Associate professor', 'role': 'CONTACT', 'email': 'arzu.erkochut@iuc.edu.tr', 'phone': '+905552735500'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Acibadem University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}