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| Is an identifier other | Other Identifier |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Care (Control Group) | Active Comparator | 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. |
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| Standard Care + Fan Therapy (Experimental Group) | Experimental | 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. Device: Hand Fan |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| STANDART CARE | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of ticagrelor-associated dyspnea | The proportion of participants who experience dyspnea within 120 minutes following ticagrelor administration will be recorded. | 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 (%) |
| Measure | Description | Time Frame |
|---|---|---|
| Time to onset of ticagrelor-associated dyspnea | The time interval between ticagrelor administration and the first reported dyspnea episode will be measured in minutes. | Time Frame: Within 120 minutes after ticagrelor administration (T1-T4) Unit of Measure: Minutes (min) |
| Measure | Description | Time Frame |
|---|---|---|
| Severity of ticagrelor-associated dyspnea | 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. | 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) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Emine Tuğba YORULMAZ, research assistant | Contact | +905556177281 | tugbayoorlmz@gmail.com | |
| Arzu ERKOÇ, Associate professor | Contact | +905552735500 | arzu.erkochut@iuc.edu.tr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| İstanbul Üniversitesi-Cerrahapaşa | Not yet recruiting | Istanbul | Avcılar | 34320 | Turkey (Türkiye) | |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol: Study Protocol | Jul 18, 2024 | Nov 10, 2025 | Prot_000.pdf |
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan: Ethics Approval | Jul 18, 2025 | Nov 10, 2025 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form: Informed Consent Form | Jul 18, 2025 | Nov 10, 2025 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D054058 | Acute Coronary Syndrome |
| D004417 | Dyspnea |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| C467559 | CCP110 protein, human |
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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.
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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.
| STANDART CARE & FAN THERAPY | Other | 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. |
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| Sağlık Bilimleri Üniversitesi Dr. Siyami Ersek Göğüs Kalp ve Damar Cerrahisi Eğitim Araştırma Hastanesi |
| Recruiting |
| Istanbul |
| Üsküdar |
| 34668 |
| Turkey (Türkiye) |
| D012120 |
| Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |