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The Effect of Slow-Paced Breathing on Patient Outcomes in Pulmonary Arterial Hypertension

E

Ege University

Status

Completed

Conditions

Pulmonary Arterial Hypertension (PAH) (WHO Group 1 PH)

Treatments

Other: Slow-paced breathing intervention

Study type

Interventional

Funder types

Other

Identifiers

NCT07232368
22-AKD-202

Details and patient eligibility

About

This study aims to investigate the effects of slow-paced breathing (SPB) intervention applied to patients with pulmonary arterial hypertension (PAH) in the home environment on symptom management (dyspnea, fatigue, sleep quality), clinical parameters (Six-Minute Walking Test-6MWT), IL-6, NT-proBNP results) and quality of life.

Full description

The therapeutic power of slow, controlled breathing has been recognized for centuries and is primarily used in relaxation techniques such as meditation and yoga.

It can be difficult for a patient to effectively perform these exercises on their own without training or individualized coaching.

Numerous studies in recent years have shown that therapeutic breathing exercises performed without conscious effort, using devices, have positive effects on parameters such as blood pressure, stress management, respiratory modulation, sleep difficulties, and quality of life.

Furthermore, the effects of slow-paced breathing performed with conscious effort using visual and auditory triggers have also been demonstrated in many studies.

Slow-paced breathing is a breathing technique that aims to slow the inhalation and exhalation phases to a controlled rate determined by a visual, auditory, or kinesthetic pacer.

While the spontaneous respiratory rate in adults is generally between 12 and 20 breaths per minute, this rate is reduced to as little as 6 breaths per minute with slow-paced breathing.

With the therapeutic use of slow-paced breathing intervention, Studies have shown that arterial baroreflex sensitivity is increased, cardiopulmonary reflexes are activated, vascular resistance is reduced, peripheral blood flow is increased, and many positive effects on the cardiovascular system and respiratory functions, including respiratory sinus arrhythmia and exercise tolerance.

There are very few studies on the outcomes of interventions aimed at symptom control, one of the most important goals of nursing care in pulmonary arterial hypertension.

The existing studies (only two) are foreign-based and uncontrolled experimental studies. While they demonstrate the positive effects of the interventions, they cannot provide comprehensive data and have limited evidence. Further studies are needed to provide sufficient evidence on the subject. Furthermore, a systematic review of the existing literature revealed that studies on PAH, a rare disease, are quite limited at all levels. The nursing literature is even more limited.

A video of a slow-paced breathing practice was used as an educational material in our research.

This video was prepared with expert support based on videos used in similar studies for educational and demonstration purposes.

The video preparation process: The presentation began with the preparation of a PowerPoint presentation using Microsoft Office 365 on a computer. The PowerPoint program's video conversion feature was used to make the presentation accessible on all platforms (Windows, iOS, Android, etc.).

The video included a visual guide (a moving ball) that was followed visually to ensure adherence to a predetermined breathing rate, accompanied by relaxing music. This visual guide asked patients to continuously inhale through the nose as the ball rose, and to continuously exhale through the mouth with pursed lips as the ball descended.

This study, which investigates the effects of slow-paced breathing intervention applied at home in patients with pulmonary arterial hypertension on symptom management, clinical parameters, and quality of life, is a study that will contribute to the literature on cardiology nursing in our country and around the world.

Enrollment

42 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Being between 18 and 65 years of age
  • Being diagnosed with PAH (pulmonary arterial hypertension)- (Group I pulmonary hypertension (idiopathic, hereditary, drug or toxin-induced, or associated with connective tissue disease, congenital heart disease, or HIV-associated)) diagnosed by right heart catheterization
  • Being on stable PAH treatment for the past three months and in a stable clinical condition (no changes in PAH medical treatment, no new medications added)
  • Being in class II or III according to the World Health Organization functional classification
  • Being able to speak Turkish
  • Having a high level of technical digital literacy (obtaining the highest score (30 points) on the "technical subscale" of the Digital Literacy Scale*)
  • Agreeing to participate in the study

Exclusion criteria

  • Communication difficulties
  • Symptomatic hypotension
  • Pregnancy status for female participants (positive urine pregnancy test*)
  • Presence of another underlying condition that may cause dyspnea, fatigue, and sleep difficulties (chronic fatigue syndrome, obstructive sleep apnea, restless legs syndrome, narcolepsy, major depression, etc.)
  • Hospitalization or acute phase
  • Active participation in a cardiac rehabilitation program
  • Presence of pulmonary hypertension due to left heart disease and pulmonary hypertension due to lung diseases and/or hypoxia
  • Receiving a lung transplant
  • Having had cardiac surgery within the last six months
  • Presence of obesity
  • Presence of mental retardation

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

42 participants in 2 patient groups

control group
No Intervention group
Description:
Data collection tools were applied to individuals in the control group at week 0 (first follow-up), week 6 (interim follow-up) and week 12 (final follow-up) of the follow-up period. The data collection tools administered to the control group were: Patient Identification Form, Multidimensional Dyspnea Profile, Multidimensional Fatigue Inventory, Pittsburgh Sleep Quality Index, Six-Minute Walk Test Form and Modified Borg Scale, Laboratory Analysis Form, and EmPHasis-10 Quality of Life Scale, Digital Literacy Scale-Technical Subscale.
initiative group
Experimental group
Description:
Data collection tools were administered to individuals in the intervention group at week 0 (initial follow-up), week 6 (interim follow-up), and week 12 (final follow-up). Data collection tools administered to the intervention group included: Patient Identification Form, Multidimensional Dyspnea Profile, Multidimensional Fatigue Inventory, Pitsburgh Sleep Quality Index, Six-Minute Walk Test Form and Modified Borg Scale, Laboratory Analysis Form, EmPHasis-10 Quality of Life Scale, Digital Literacy Scale-Technical Subscale.
Treatment:
Other: Slow-paced breathing intervention

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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