Heart FailureNCT06838169
The Effect of Vırtual Realıty Glasses on Heart Faılure Patıents
A study testing Virtual reality glasses and breathing exercise in people with Heart Failure, run by Bayburt University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Virtual reality glasses and breathing exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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),
Show all 11Show fewer
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
T.C. Erciyes University Faculty of Medicine Hospitals
Kayseri, Talas, 38000
About this study
Official title: 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.
- Conditions
- Heart Failure
- Being tested
- Virtual reality glasses, breathing exercise
- Keywords
- Heart failure, Virtual reality glasses, Anxiety, Respiration, Sleep Quality
- Medical subject headings
- Heart Failure, Anxiety Disorders, Respiratory Aspiration, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual reality glassesBehavioural
virtual reality glasses application
breathing exerciseBehavioural
breathing exercise app
| Study group | Role | What they receive |
|---|---|---|
| Virtual reality glasses + breathing exercise app | Experimental | Virtual reality glasses + breathing exercise app Receives: Behavioral: Virtual reality glasses; Behavioral: breathing exercise |
| Breathing exercise practice | Active comparator | Breathing exercise practice Receives: Behavioral: breathing exercise |
| Kontrol | No intervention | No application will be made |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety level
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.
Measured: Apply the morning before application and the morning 7 days after application.
Secondary outcomes (1)
Sleep Quality
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.
Measured: Apply the morning before application and the morning 7 days after application.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2025
- Study start1 Oct 2025
- Primary completion1 Dec 2025
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bayburt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Servet KALYONCUO, Bayburt University
- Investigators
- Servet Kalyoncuo, Principal investigator, ERCİYES UNIVERSITY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06838169
- Sponsor's protocol ID
- RCS2253148
- Status last verified
- Sep 2026
- First submitted
- 16 Jan 2025
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 25701969
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Breathıng Exercıses wıth Vırtual Realıty Glasses on Anxıety Levels, Sleep Qualıty and Respıratory Parameters in Heart Faılure Patıents
- ClinicalTrials.gov ID
- NCT06838169
- Acronym / sponsor ID
- RCS2253148
- Conditions
- Heart Failure
- Keywords
- Heart failure, Virtual reality glasses, Anxiety, Respiration, Sleep Quality
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Bayburt UniversityUniversity, hospital or other
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 1 Dec 2025 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 20 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Virtual reality glasses + breathing exercise app | Experimental | Behavioral: Virtual reality glasses, Behavioral: breathing exerciseVirtual reality glasses + breathing exercise app |
| Breathing exercise practice | Active comparator | Behavioral: breathing exerciseBreathing exercise practice |
| Kontrol | No intervention | –No application will be made |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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,
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual reality glassesvirtual reality glasses application | Behavioural | Virtual reality glasses + breathing exercise app |
| breathing exercisebreathing exercise app | Behavioural | Breathing exercise practice, Virtual reality glasses + breathing exercise app |
Primary outcome
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.
1 secondary outcome
Sleep Quality
Time frame: Apply the morning before application and the morning 7 days after application.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
- Background: PubMed 25701969Polikandrioti 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.
- referancesLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Heart Failure
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Not yet recruitingPhase 2
A Study of Bimagrumab in Participants With HFpEF
Heart Failure, Diastolic, Diastolic Heart Failure
Recruiting
Evaluation of a French Hospital Discharge Therapeutic Education Program by Nurses for Heart Failure Patient (EduSor)
Heart Failure
Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
Not yet recruiting
RELIEVE-HFrEF TRIAL: REducing Lung congestIon Symptoms Using the v-wavE Shunt in adVancEd Heart Failure With Reduced EF
Heart Failure and Reduced Ejection Fraction, Heart Failure Chronic
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Servet Kalyoncuo principal investigator
ERCİYES UNIVERSITY
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual reality glasses and breathing exercise in people with Heart Failure, run by Bayburt University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anxiety level (time frame: Apply the morning before application and the morning 7 days after application.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06838169, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2026.