- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06838169
The Effect of Vırtual Realıty Glasses on Heart Faılure Patıents
July 1, 2025 updated by: Servet KALYONCUO, Bayburt University
Effects of Breathıng Exercıses wıth Vırtual Realıty Glasses on Anxıety Levels, Sleep Qualıty and Respıratory Parameters in 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.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
45
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Servet KALYONCUO
- Phone Number: (458) 211-1176
- Email: servetkalyoncu38@gmail.com
Study Contact Backup
- Name: Özlem CEYHAN
- Email: ozlemg@erciyes.edu.tr
Study Locations
-
-
Talas
-
Kayseri, Talas, Turkey, 38000
- T.C. Erciyes University Faculty of Medicine Hospitals
-
Contact:
- Servet Kalyoncuo
- Phone Number: 05063096866
- Email: servetkalyoncu38@gmail.com
-
Principal Investigator:
- Servet KALYONCUO
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Virtual reality glasses + breathing exercise app
|
virtual reality glasses application
breathing exercise app
|
|
Active Comparator: Breathing exercise practice
|
breathing exercise app
|
|
No Intervention: Kontrol
No application will be made
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Apply the morning before application and the morning 7 days after application.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Apply the morning before application and the morning 7 days after application.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Servet Kalyoncuo, Erciyes University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
October 1, 2025
Primary Completion (Estimated)
October 1, 2025
Study Completion (Estimated)
December 30, 2025
Study Registration Dates
First Submitted
January 16, 2025
First Submitted That Met QC Criteria
February 18, 2025
First Posted (Actual)
February 20, 2025
Study Record Updates
Last Update Posted (Actual)
July 3, 2025
Last Update Submitted That Met QC Criteria
July 1, 2025
Last Verified
July 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RCS2253148
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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