Skip to main content
Clinical Trials/NCT06838169
NCT06838169Not yet recruitingNot Applicable

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

Bayburt University2 sites in 1 country45 target enrollmentStarted: October 1, 2025Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Enrollment
45
Locations
2
Primary Endpoint
Anxiety level

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
Double (Participant, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Arms & Interventions

Virtual reality glasses + breathing exercise app

Experimental

Virtual reality glasses + breathing exercise app

Intervention: breathing exercise (Behavioral)

Virtual reality glasses + breathing exercise app

Experimental

Virtual reality glasses + breathing exercise app

Intervention: Virtual reality glasses (Behavioral)

Breathing exercise practice

Active Comparator

Breathing exercise practice

Intervention: breathing exercise (Behavioral)

Kontrol

No Intervention

No application will be made

Outcomes

Primary Outcomes

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

  • Sleep Quality(Apply the morning before application and the morning 7 days after application.)

Investigators

Sponsor
Bayburt University
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Servet KALYONCUO

Research Assistant

Bayburt University

Study Sites (2)

Loading locations...

Similar Trials