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临床试验/NCT06838169
NCT06838169尚未招募不适用

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

Bayburt University2 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2025年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
45
试验地点
2
主要终点
Anxiety level

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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

排除标准

  • •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.

研究组 & 干预措施

Virtual reality glasses + breathing exercise app

Experimental

Virtual reality glasses + breathing exercise app

干预措施: breathing exercise (Behavioral)

Virtual reality glasses + breathing exercise app

Experimental

Virtual reality glasses + breathing exercise app

干预措施: Virtual reality glasses (Behavioral)

Breathing exercise practice

Active Comparator

Breathing exercise practice

干预措施: breathing exercise (Behavioral)

Kontrol

No Intervention

No application will be made

结局指标

主要结局

Anxiety level

时间窗: 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.

次要结局

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

研究者

发起方
Bayburt University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Servet KALYONCUO

Research Assistant

Bayburt University

研究点 (2)

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