Effect of Fan Application in Preventing Ticagrelor-Associated Dyspnea

NCT ID: NCT07268859

Last Updated: 2025-12-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-15

Study Completion Date

2026-01-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Acute Coronary Syndromes Ticagrelor Dyspnea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors
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.

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

STANDART CARE

Intervention Type 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.

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

Group Type EXPERIMENTAL

STANDART CARE & FAN THERAPY

Intervention Type 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.

Interventions

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STANDART CARE

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.

Intervention Type OTHER

STANDART CARE & FAN THERAPY

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.

Intervention Type OTHER

Other Intervention Names

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Fan

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Acibadem University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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İstanbul Üniversitesi-Cerrahapaşa

Istanbul, Avcılar, Turkey (Türkiye)

Site Status NOT_YET_RECRUITING

Sağlık Bilimleri Üniversitesi Dr. Siyami Ersek Göğüs Kalp ve Damar Cerrahisi Eğitim Araştırma Hastanesi

Istanbul, Üsküdar, Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Emine Tuğba YORULMAZ, research assistant

Role: CONTACT

+905556177281

Arzu ERKOÇ, Associate professor

Role: CONTACT

+905552735500

Provided Documents

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Document Type: Study Protocol: Study Protocol

View Document

Document Type: Study Protocol and Statistical Analysis Plan: Ethics Approval

View Document

Document Type: Informed Consent Form: Informed Consent Form

View Document

Other Identifiers

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Is an identifier other

Identifier Type: OTHER

Identifier Source: secondary_id

ATADEK2024-10/449

Identifier Type: -

Identifier Source: org_study_id

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