Effect Of Virtual Reality On Pulmonary Function And Anxiety Levels In Asthmatic Patients
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Control pause breathing test
研究概览
简要总结
The Purpose of the Study This study will be conducted to determine the effect of virtual reality on pulmonary function and anxiety levels in moderate to severe asthmatic patients.
详细描述
Globally, asthma is the 16th cause of years-lived with-disability and the 28th most common source of burden of disease; it accounts for 1 in every 250 deaths. In Egypt, over 6.7% and 26.5% of the general adult and pediatric population, respectively, have asthma. At least 1/3 of the patients with persistent asthma experience symptoms of anxiety/depression. There is a lack of data regarding other asthma subgroups, namely adolescents and those with mild or moderate persistent asthma.
Recently, there has been a global concern for the treatment of asthma through physical therapy and complementary alternative medicine (CAM). Buteyko breathing technique is one of CAM techniques that is becoming more prevalent.
Virtual reality is an emerging new technology that has drawn scientists' attention to its potential impact on rehabilitation. It is a safe and effective medium for supporting stress and anxiety management.
In general, the literature has shown that VR This would enable users to learn over time how to change their physiological activity to enhance health and performance, reduce stress-related symptoms, and increase their well-being.
Up to investigated knowledge, No previous studies conducted to explore the effect of VR on pulmonary function and anxiety in adult patients with moderate to sever bronchial asthma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Both sexes would be previously diagnosed as bronchial asthma with a cut-off score FEV1: Between 60% and 80% of predicted value or less than 60% of predicted value and FEV1/FVC ratio: May be significantly reduced from normal value 0.75-0.
- •The age of the patients will be ranged between 30 and 40 years old.
- •Asthma Control Test(ACT) will be less than 16 can be successfully used to identify those who will be uncontrolled asthma.
- •All patients will be assessed by Hospital Anxiety and Depression Scale (HADS) ;A cut-off score of 11-15 a moderate depression/anxiety level.
- •Patients who are conscious and cooperative.
- •Patients who are able to understand and follow instruction.
排除标准
- •Previous participation in any pulmonary rehabilitation program.
- •Cardiovascular instabilities such as: Uncontrolled hypertension, Uncontrolled arrhythmia and Recent ischemic event.
- •Mental disorders preventing protocol implementation.
- •Other chronic respiratory diseases.
- •Pregnant women.
- •New or current smoker.
- •Respiratory tract infection.
研究组 & 干预措施
Buteyko breathing exercise group
The participant will participate in Buteyko breathing only twice\ week for 8 weeks and the session was about 10 min, with their optimal medical treatment,which depending on three steps:
Step 1: The ''Control pause (CP)'' breathing test Step 2: Shallow breathing Sit up straight Step 3: Putting it together Take Control pause
干预措施: Buteyko Breathing (Procedure)
Virtual Reality group
The participants will receive 20 min VR and Buteyko breathing along with prescribed medical treatment for 8 weeks , twice \week. Training depends on two breathing training aspects with 5 breathing cycles for each one, 30 sec rest in between. in form of: Colour Breathing VR program (Box Breathing), LAMINAL VR (Calm).
干预措施: Virtual reality glass (Device)
结局指标
主要结局
Control pause breathing test
时间窗: 8 weeks
It is part of the Buteyko method of breathing exercises and is designed to measure the length of time a person can comfortably hold their breath after a normal exhalation. its normal range is between 0-60 seconds, less than 20 seconds means poor control.
Asthma control test
时间窗: 8 weeks
It was a commonly valuable tool to assess asthma control that typically involves a self-reported questionnaire that evaluates symptoms over the past 4 weeks. It is self reported 5-25 scale. Higher score indicates better control. less than 16 indicates uncolntrolled asthma
Forced Expiratory Volume in one second (FEV1)
时间窗: 8 weeks
FEV1 stands for Forced Expiratory Volume in 1 second. It is a measurement taken during a spirometry test, which assesses lung function. Specifically, it measures the amount of air a person can forcefully exhale in the first second of a forced exhalation. A lower FEV1 reading can indicate an obstruction in the airways, potentially pointing to conditions like asthma. Normal values for % predicted FEV1 are generally 80% or higher of the predicted value. 60-80%moderate, \<60% severe.
Forced vital capacity (FVC)
时间窗: 8 weeks
Forced vital capacity (FVC) is the maximum amount of air a person can exhale after taking the deepest possible breath. It's a key measurement in spirometry, a common breathing test used to assess lung function. FVC helps doctors identify and distinguish between different types of lung diseases, including obstructive (like asthma). FVC can also be expressed as a percentage of the predicted value, with 80% to 120% considered within the normal range
FEV1/FVC ratio
时间窗: 8 weeks
The FEV1/FVC ratio is a calculation used in pulmonary function tests, specifically spirometry, to assess lung function. It represents the proportion of a person's forced vital capacity (FVC) that they can exhale in the first second of a forced expiration, known as forced expiratory volume in 1 second (FEV1). A normal FEV1/FVC ratio is typically above 70% (0.75-0.80), and a lower ratio suggests an airway obstruction
Peak expiratory flow (% predicted)
时间窗: 8 weeks
It refers to the percentage of a person's measured PEF compared to their predicted PEF, based on factors like age, sex, and height. It's a way to assess how well someone is breathing compared to what's expected for them, with lower percentages often indicating airflow obstruction such as asthma. PEF predicted % is calculated by dividing the actual PEF measurement by the predicted PEF and multiplying by 100. A lower PEF predicted % generally indicates a greater degree of airflow obstruction. For example, in asthma, a PEF predicted % below 50% may indicate a severe exacerbation.
Anxiety level by Hospital Anxiety and Depression Scale (HADS)
时间窗: 8 weeks
It is a 14-item questionnaire that assesses anxiety and depression symptoms for all participants before and after the treatment program. It has two seven-item subscales, one for anxiety and one for depression. Each item is scored on a 4-point scale, with a maximum score of 21 for each subscale. Scores are categorized as normal (0-7), mild (8-10), moderate (11-14), and severe (15-21) for both anxiety and depression.
次要结局
- Treatment Adherence Perception Questionnaire(TAPQ)(8 weeks)
- Functional capacity(8 weeks)
- Frequency of exacerbations (time/day)(8 weeks)
研究者
Mai Gomaa Mohamed Abdelrahman
Principal Investigator
October 6 University