The Effect of Vırtual Realıty Glasses on Heart Faılure Patıents

NCT06838169 | Not Yet Recruiting DMC

• 1 other identifier: RCS2253148
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure

Keywords

Heart failure; Virtual reality glasses; Anxiety; Respiration; Sleep Quality

Outcome Measures

Primary Outcomes (1)

• 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.

  Apply the morning before application and the morning 7 days after application.

Secondary Outcomes (1)

• Sleep Quality

  Apply the morning before application and the morning 7 days after application.

Study Arms (3)

Virtual reality glasses + breathing exercise app

EXPERIMENTAL

Virtual reality glasses + breathing exercise app

Behavioral: Virtual reality glasses; Behavioral: breathing exercise

Breathing exercise practice

ACTIVE COMPARATOR

Breathing exercise practice

Behavioral: breathing exercise

Kontrol

NO INTERVENTION

No application will be made

Interventions

Virtual reality glasses BEHAVIORAL

virtual reality glasses application

Virtual reality glasses + breathing exercise app

breathing exercise BEHAVIORAL

breathing exercise app

Breathing exercise practice; Virtual reality glasses + breathing exercise app

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bayburt University: lead

Study Sites (1)

T.C. Erciyes University Faculty of Medicine Hospitals

Kayseri, Talas, 38000, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 25701969 BACKGROUND

Related Links

• referances

MeSH Terms

Conditions

Heart Failure; Anxiety Disorders; Respiratory Aspiration; Sleep Initiation and Maintenance Disorders

Interventions

Breathing Exercises

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Mental Disorders; Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Exercise Movement Techniques; Physical Therapy Modalities

Study Officials

• Servet Kalyoncuo

  ERCİYES UNIVERSITY

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Servet KALYONCUO

CONTACT

(458) 211-1176; servetkalyoncu38@gmail.com

Özlem CEYHAN

CONTACT

ozlemg@erciyes.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Study Record Dates

• First Submitted: January 16, 2025
• First Posted: February 20, 2025
• Study Start: October 1, 2025
• Primary Completion: October 1, 2025
• Study Completion: December 30, 2025
• Last Updated: July 3, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)