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NCT Number: NCT06838169

The Effect of Vırtual Realıty Glasses on Heart Faılure Patıents

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.

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Key information

Conditions

Heart Failure Anxiety Disorders Cardiovascular Diseases Dyssomnias Heart Diseases Mental Disorders Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Aspiration Respiratory Tract Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

T.C. Erciyes University Faculty of Medicine Hospitals

Kayseri, Talas, 38000, Turkey (Türkiye)

Location contact

Servet KALYONCUO

PRINCIPAL_INVESTIGATOR

Servet Kalyoncuo

CONTACT

[email protected]

05063096866

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Virtual Reality Glasses

Behavioral

virtual reality glasses application

BREATHING EXERCISE

Behavioral

breathing exercise app

Primary outcomes

  1. Anxiety level

    Time frame: Apply the morning before application and the morning 7 days after application.

    Turkish adaptation of the state-trait anxiety inventory short version (STAIS-5, STAIT-5). This form is a 4-point Likert type. It is an easy-to-apply inventory consisting of a total of 10 statements. As the score obtained in this form increases, the level of anxiety also increases.

Secondary outcomes

  1. Sleep Quality

    Time frame: Apply the morning before application and the morning 7 days after application.

    Richard Campbell Sleep Quality Scale (RCSQ) for sleep quality level assessment.This form is a 6-item scale. According to the scale scoring, a score between "0-25" indicates very poor sleep, and a score between "76-100" indicates very good sleep.

Study contacts

Contact information is provided by the study sponsor or research team.

Servet KALYONCUO

CONTACT

[email protected]

(458) 211-1176

Özlem CEYHAN

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Bayburt University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Feb 20, 2025
Registry last updated
Jul 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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