NCT07268859

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
110

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2025

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 15, 2025

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 18, 2025

Completed
6 months until next milestone

First Posted

Study publicly available on registry

December 8, 2025

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 10, 2026

Completed
20 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2026

Completed
Last Updated

December 8, 2025

Status Verified

August 1, 2025

Enrollment Period

10 months

First QC Date

June 18, 2025

Last Update Submit

December 4, 2025

Conditions

Keywords

NursingTicagrelorHand fan therapyDyspneaNon-pharmacological intervention

Outcome Measures

Primary Outcomes (1)

  • 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 (%)

Secondary Outcomes (1)

  • Time to onset of ticagrelor-associated dyspnea

    Time Frame: Within 120 minutes after ticagrelor administration (T1-T4) Unit of Measure: Minutes (min)

Other Outcomes (1)

  • Severity of ticagrelor-associated dyspnea

    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)

Study Arms (2)

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.

Other: STANDART CARE

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

Other: STANDART CARE & FAN THERAPY

Interventions

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 (Control 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.

Also known as: Fan
Standard Care + Fan Therapy (Experimental Group)

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

İstanbul Üniversitesi-Cerrahapaşa

Istanbul, Avcılar, 34320, Turkey (Türkiye)

NOT YET RECRUITING

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

Istanbul, Üsküdar, 34668, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Acute Coronary SyndromeDyspnea

Interventions

CCP110 protein, human

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesRespiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Emine Tuğba YORULMAZ, research assistant

CONTACT

Arzu ERKOÇ, Associate professor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
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.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 18, 2025

First Posted

December 8, 2025

Study Start

March 15, 2025

Primary Completion

January 10, 2026

Study Completion

January 30, 2026

Last Updated

December 8, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations