The Effect of Vırtual Realıty Glasses on Heart Faılure Patıents

NCT ID: NCT06838169

Last Updated: 2025-07-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-01

Study Completion Date

2025-12-30

Brief Summary

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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.

Detailed Description

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Conditions

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Heart Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Virtual reality glasses + breathing exercise app

Virtual reality glasses + breathing exercise app

Group Type EXPERIMENTAL

Virtual reality glasses

Intervention Type BEHAVIORAL

virtual reality glasses application

breathing exercise

Intervention Type BEHAVIORAL

breathing exercise app

Breathing exercise practice

Breathing exercise practice

Group Type ACTIVE_COMPARATOR

breathing exercise

Intervention Type BEHAVIORAL

breathing exercise app

Kontrol

No application will be made

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Virtual reality glasses

virtual reality glasses application

Intervention Type BEHAVIORAL

breathing exercise

breathing exercise app

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bayburt University

OTHER

Sponsor Role lead

Responsible Party

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Servet KALYONCUO

Research Assistant

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Servet Kalyoncuo

Role: PRINCIPAL_INVESTIGATOR

ERCİYES UNIVERSITY

Locations

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T.C. Erciyes University Faculty of Medicine Hospitals

Kayseri, Talas, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Central Contacts

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Servet KALYONCUO

Role: CONTACT

(458) 211-1176

Özlem CEYHAN

Role: CONTACT

Facility Contacts

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Servet Kalyoncuo

Role: primary

05063096866

References

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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.

Reference Type BACKGROUND
PMID: 25701969 (View on PubMed)

Related Links

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Other Identifiers

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RCS2253148

Identifier Type: -

Identifier Source: org_study_id

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