- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07268859
Effect of Fan Application in Preventing Ticagrelor-Associated Dyspnea (ACS)
December 4, 2025 updated by: Acibadem University
Effect of Fan Application in Preventing Ticagrelor-associated Dyspnea in Patients With Acute Coronary Syndrome.
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Interventional
Enrollment (Estimated)
110
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Emine Tuğba YORULMAZ, research assistant
- Phone Number: +905556177281
- Email: tugbayoorlmz@gmail.com
Study Contact Backup
- Name: Arzu ERKOÇ, Associate professor
- Phone Number: +905552735500
- Email: arzu.erkochut@iuc.edu.tr
Study Locations
-
-
Avcılar
-
Istanbul, Avcılar, Turkey (Türkiye), 34320
- Not yet recruiting
- İstanbul Üniversitesi-Cerrahapaşa
-
-
Üsküdar
-
Istanbul, Üsküdar, Turkey (Türkiye), 34668
- Recruiting
- Sağlık Bilimleri Üniversitesi Dr. Siyami Ersek Göğüs Kalp ve Damar Cerrahisi Eğitim Araştırma Hastanesi
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Between the ages of 18 and 65,
- No severe hearing and vision problems,
- Can speak and understand Turkish,
- Easy to communicate with,
- First-time sufferer of acute coronary syndrome (ACS) for the first time,
- Decided to start ticagrelor therapy,
- Able to adapt to treatment,
- Individuals who volunteered to participate in the research.
Exclusion Criteria:
- Having any problem that prevents you from communicating cognitively, emotionally and verbally,
- Obstructive sleep abnormalities,
- 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.),
- With metabolic abnormalities,
- Intubated after the procedure,
- Previously treated with ticagrelor,
- Individuals who did not volunteer to participate in the study. Losses to follow up
- Individuals who wish to leave the study voluntarily.
- Saturation value below 95%,
- The one with the arrest,
- Who will not be able to fulfill the requirements of the work,
- Individuals with life-threatening conditions
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Standard Care (Control Group)
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.
|
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.
|
|
Experimental: Standard Care + Fan Therapy (Experimental Group)
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 |
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Incidence of ticagrelor-associated dyspnea
Time Frame: 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 (%)
|
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 (%)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Time to onset of ticagrelor-associated dyspnea
Time Frame: Time Frame: Within 120 minutes after ticagrelor administration (T1-T4) Unit of Measure: Minutes (min)
|
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)
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Severity of ticagrelor-associated dyspnea
Time Frame: 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)
|
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)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 15, 2025
Primary Completion (Estimated)
January 10, 2026
Study Completion (Estimated)
January 30, 2026
Study Registration Dates
First Submitted
June 18, 2025
First Submitted That Met QC Criteria
December 4, 2025
First Posted (Actual)
December 8, 2025
Study Record Updates
Last Update Posted (Actual)
December 8, 2025
Last Update Submitted That Met QC Criteria
December 4, 2025
Last Verified
August 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ATADEK2024-10/449
- Is an identifier other (Other Identifier)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Dyspnea
-
Hospital de Clinicas José de San MartínRecruitingDyspnea During Mechanical VentilationArgentina
-
Ziekenhuis Oost-LimburgRecruitingDyspnea; CardiacBelgium
-
Cook Children's Health Care SystemNot yet recruitingExercise-Induced Laryngeal Obstruction | Dyspnea During ActivityUnited States
-
Pr. Nicolas GIRERDNot yet recruiting
-
Riphah International UniversityCompletedDyspnea, ParoxysmalPakistan
-
Qure Healthcare, LLCJohnson & Johnson Pharmaceutical Research & Development, L.L.C.CompletedDyspnea | Unexplained Chronic DyspneaUnited States
-
University of LahoreUniversity of Lahore Hospital (ULH)CompletedDyspnea During Pregnancy | Physiological Changes in Pregnancy | Reduced Functional EndurancePakistan
-
Mayo ClinicCompletedShortness of Breath | Cardiac; DyspneaUnited States
-
Assistance Publique - Hôpitaux de ParisCompletedRelationship Between Dyspnea and Ventilatory VariabilityFrance
-
University of MonastirCompleted
Clinical Trials on STANDART CARE
-
Hacettepe UniversityCompletedInvestigation of Inspiratory Muscle Strength and Cardiorespiratory Fitness in Sarcopenic IndividualsGeriatric IndividualsTurkey
-
Istanbul University - CerrahpasaThe Scientific and Technological Research Council of TurkeyCompleted
-
Kutahya Health Sciences UniversityCompletedCoronary Artery Disease | Pain, Postoperative | Sleep DisorderTurkey
-
Istanbul Medipol University HospitalCompletedEmphysema | Pulmonary Rehabilitation | Bronchoscopic Lung Volume Reduction
-
Recep Tayyip Erdogan Universityİstanbul Yeni Yüzyıl ÜniversitesiNot yet recruiting
-
University Hospital, LimogesRecruitingSexuality | Rectal Tumor | Women | Life QualityFrance
-
Saglik Bilimleri UniversitesiCompletedColostomy - Stoma | Will Include Individuals Who Will Undergo Colostomy | ho'Oponopono | Adaptation to the OstomyTurkey (Türkiye)
-
Tarsus UniversityCompletedCardiac Resynchronization TherapyTurkey
-
Mersin UniversityCompletedPsychological Well-being | Childbirth | Care Pattern, MaternalTurkey
-
Recep Tayyip Erdogan Universityİstanbul Yeni Yüzyıl ÜniversitesiNot yet recruitingInterstitial Lung Disease (ILD)