NCT07752706

Brief Summary

Heart failure is a leading cause of emergency department admissions, with dyspnea and psychological distress being among the most common presenting symptoms. This randomized controlled trial aims to evaluate the effect of nurse-guided diaphragmatic breathing and pursed-lip breathing exercises on dyspnea and psychological distress in patients presenting to the emergency department with heart failure. A total of 112 eligible participants will be randomly assigned in a 1:1 ratio to either an intervention group receiving breathing exercises in addition to standard care or a control group receiving standard care alone. Dyspnea severity will be assessed using the Modified Borg Dyspnea Scale, and psychological distress will be assessed using the Distress Thermometer at predefined time points. The findings are expected to provide evidence for the effectiveness of a simple, low-cost, nurse-led non-pharmacological intervention in improving symptom management in patients with heart failure.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
112

participants targeted

Target at P50-P75 for not_applicable heart-failure

Timeline
2mo left

Started Mar 2025

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress91%
Mar 2025Dec 2026

Study Start

First participant enrolled

March 5, 2025

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

July 11, 2026

Completed
27 days until next milestone

First Posted

Study publicly available on registry

August 7, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 5, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 5, 2026

Last Updated

August 7, 2026

Status Verified

March 1, 2026

Enrollment Period

1.8 years

First QC Date

July 11, 2026

Last Update Submit

August 3, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • Change in psychological distress measured by the Distress Thermometer

    Psychological distress will be assessed using the Distress Thermometer

    Baseline (before intervention), and at 5, 10, 15, 30, 45, and 60 minutes after initiation of the intervention.

  • Change in dyspnea severity measured by the Modified Borg Dyspnea Scale

    Dyspnea severity will be assessed using the Modified Borg Dyspnea Scale

    Baseline (before intervention), and at 5, 10, 15, 30, 45, and 60 minutes after initiation of the intervention.

Study Arms (2)

Control

NO INTERVENTION

No Intervention

Experimental

EXPERIMENTAL

Behavioral: Diaphragmatic and Pursed-Lip Breathing Exercises

Other: Diaphragmatic and Pursed-Lip Breathing Exercises

Interventions

Participants received standard emergency department care plus nurse-guided diaphragmatic breathing and pursed-lip breathing exercises. The intervention consisted of three cycles of breathing exercises with rest periods between cycles. Participants were observed and supported throughout the intervention.

Experimental

Eligibility Criteria

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

You may qualify if:

  • Applicants must be 18 years of age or older. Volunteer to participate in the study. Present to the emergency department of the hospital where the study is planned to be conducted.
  • Having been diagnosed with NYHA stage III-IV heart failure by a physician. Being able to understand and speak Turkish.

You may not qualify if:

  • Being under 18 years of age Not being a volunteer to participate in the study Using narcotic analgesics to a degree that affects understanding questions and communication, Having a diagnosis of serious mental illness Not having been diagnosed with NYHA stage III-IV heart failure by a physician

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

İstanbul Üniversitesi-Cerrahpaşa

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Heart FailureDyspneaAnxiety Disorders

Interventions

Contraceptive Devices, Female

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesRespiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Intervention Hierarchy (Ancestors)

Contraceptive DevicesEquipment and Supplies

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Due to the nature of the breathing exercise intervention, participants and the investigator delivering the intervention could not be blinded. To minimize bias, data were coded as Group A and Group B, and statistical analyses were performed by an independent statistician who was blinded to group allocation.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
phd student

Study Record Dates

First Submitted

July 11, 2026

First Posted

August 7, 2026

Study Start

March 5, 2025

Primary Completion (Estimated)

December 5, 2026

Study Completion (Estimated)

December 5, 2026

Last Updated

August 7, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will share

Individual participant data will be available upon reasonable request from the corresponding author after publication of the study. Data will be shared in anonymized form.

Locations