Effect Of Virtual Reality On Pulmonary Function And Anxiety Levels In Asthmatic Patients

Обзор

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.

Подробное описание

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.

HYPOTHESES: It will be hypothesized that there will be no significant effect of Virtual Reality on pulmonary function and anxiety levels in patients with moderate to sever bronchial asthma.

RESERCH QUESTION: Does virtual reality affect pulmonary function and anxiety levels in moderate to severe asthmatic patients?

Вмешательства

• Устройство Virtual reality glass
  Virtual reality (VR), with its immersion and interactivity, offers the possibility to amplify the effectiveness of breathing techniques in promoting mental health by creation of relaxing scenarios and has been successfully employed in promoting relaxation and stress reduction. Virtual reality can turn breathing exercises into an interactive experience that feels more like a fun activity than a tedious task. It consists of VR headset, two touch controllers, glasses spacer with adjustable straps f
• Процедура Buteyko Breathing
  1. The ''Control pause (CP)'' breathing test: Hold his nose on the "out" breath, with empty lungs but not too empty and count how many seconds that he can comfortably last before the need to breathe in again. 2. Shallow breathing Sit up straight: breathe air slightly into the tip of the nostrils. Concentrate on calming his breath to reduce the amount of warm air he feel on his finger, try to maintain the need for air for about 4 min. 3. Putting it together Take Control pause: Reduced breathing

Первичные конечные точки

• Control pause breathing test [Срок оценки: 8 weeks]
• Asthma control test [Срок оценки: 8 weeks]
• Forced Expiratory Volume in one second (FEV1) [Срок оценки: 8 weeks]
• Forced vital capacity (FVC) [Срок оценки: 8 weeks]
• FEV1/FVC ratio [Срок оценки: 8 weeks]
• Peak expiratory flow (% predicted) [Срок оценки: 8 weeks]
• Anxiety level by Hospital Anxiety and Depression Scale (HADS) [Срок оценки: 8 weeks]

Вторичные конечные точки (3)

• Treatment Adherence Perception Questionnaire(TAPQ) [Срок оценки: 8 weeks]
• Functional capacity [Срок оценки: 8 weeks]
• Frequency of exacerbations (time/day) [Срок оценки: 8 weeks]

Критерии участия

Критерии включения

• 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 0.75-0.80.
• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Египет · 1 центр

• October 6 university hospital outpatient chest department — Giza

Публикации

• Esposito C, Autorino G, Iervolino A, Vozzella EA, Cerulo M, Esposito G, Coppola V, Carulli R, Cortese G, Gallo L, Escolino M. Efficacy of a Virtual Reality Program in Pediatric Surgery to Reduce Anxiety and Distress Symptoms in the Preoperative Phase: A Prospective Randomized Clinical Trial. J Laparoendosc Adv Surg Tech A. 2022 Feb;32(2):197-203. doi: 10.1089/lap.2021.0566. Epub 2021 Dec 28. PMID 34962159

Идентификаторы

NCT: NCT07141212 · Virtual Reality in Asthma

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗