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Not yet recruiting NCT06838169

The Effect of Vırtual Realıty Glasses on Heart Faılure Patıents

No phase Interventional Heart Failure

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Virtual reality glasses, breathing exercise.
Who it may be relevant to
Registry conditions: Heart Failure. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Effects of Breathıng Exercıses wıth Vırtual Realıty Glasses on Anxıety Levels, Sleep Qualıty and Respıratory Parameters in Heart Faılure Patıents

Overview

Anxiety and sleep disorders are among the most common symptoms in heart failure patients. In addition to pharmacological methods for anxiety and sleep disorders, non-pharmacological methods can also be used. Among these, anxiety and sleep disorders can be prevented with virtual reality glasses aimed at distraction. This study will be conducted to evaluate the effect of breathing exercises performed with virtual reality glasses on anxiety, sleep quality, and respiratory parameters. The study will be conducted with a total of 45 patients, 15 virtual reality glasses + breathing exercises, 15 breathing exercises, and 15 controls. Those in the virtual reality glasses + breathing exercises group will perform breathing exercises with virtual reality glasses once a day for 7 days. Those in the breathing exercises group will perform only breathing exercises once a day for 7 days. Anxiety, sleep disorders, and respiratory parameters of the patients will be examined.

Interventions

  • Behavioral Virtual reality glasses
    virtual reality glasses application
  • Behavioral breathing exercise
    breathing exercise app

Primary outcome measures

  • Anxiety level [Time frame: Apply the morning before application and the morning 7 days after application.]
Secondary outcome measures (1)
  • Sleep Quality [Time frame: Apply the morning before application and the morning 7 days after application.]

Eligibility criteria

Inclusion criteria

  • 18 years of age or older,
  • Verbal communication,
  • Place and time oriented,
  • Without any psychiatric illness,
  • Patients diagnosed with HF with NYHA class III-IV symptoms,
  • Left ventricular ejection fraction ≥50% (LVEF-CF/HFpEF), between 40-49% (SEF-CF/HFmrEF), HF below 40% (DEF-CF/HFrEF),
  • High levels of natriuretic peptides (BNP\>35 pg/mL and/or NTproBNP\>125 pg/mL),
  • There is no deformity or diagnosis related to the musculoskeletal system that may prevent breathing exercise,
  • Chronic diseases such as hypertension (Stage 1 and 2 HT) and diabetes mellitus are stable and the treatment for these diagnoses has not been changed in the last month,
  • Who have not previously received respiratory exercise training and have not participated in a rehabilitation program,
  • Patients who volunteer to participate in the study will be included in the study

Exclusion criteria

  • Life signs are so abnormal as to preclude intervention,
  • Patients with migraine, vertigo, active nausea-vomiting, headache, dizziness will not be included in the study.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Supportive care

Study locations

Turkey (Türkiye) · 1 center
  • T.C. Erciyes University Faculty of Medicine Hospitals — Kayseri

Publications

  • Polikandrioti M, Goudevenos J, Michalis LK, Koutelekos J, Kyristi H, Tzialas D, Elisaf M. Factors associated with depression and anxiety of hospitalized patients with heart failure. Hellenic J Cardiol. 2015 Jan-Feb;56(1):26-35. PMID 25701969

Identifiers

NCT: NCT06838169 · RCS2253148

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗