Clinical trial NCT06838169: The Effect of Vırtual Realıty Glasses on Heart Faılure Patıents
Official title: Effects of Breathıng Exercıses wıth Vırtual Realıty Glasses on Anxıety Levels, Sleep Qualıty and Respıratory Parameters in Heart Faılure Patıents
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Heart Failure
Keywords: Heart failure
Virtual reality glasses
Anxiety
Respiration
Sleep Quality
Lead sponsor: Bayburt University
Sponsor class: OTHER
First posted: 2025-02-20
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.


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\&gt;35 pg/mL and/or NTproBNP\&gt;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.

Primary outcomes:
measure: Anxiety level
timeFrame: Apply the morning before application and the morning 7 days after application.
Secondary outcomes:
measure: Sleep Quality
timeFrame: Apply the morning before application and the morning 7 days after application.
Other outcomes:
Locations:
city: Kayseri
country: Turkey
facility: T.C. Erciyes University Faculty of Medicine Hospitals
state: Talas
Study officials:
affiliation: ERCİYES UNIVERSITY
name: Servet Kalyoncuo
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.