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

ConditionAsthma
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age30-40
SponsorOctober 6 University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Virtual reality glass

    Device

    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 for good vision as follows: 1. Colour Breathing VR program (Box Breathing) : Patient sit in comfortable position with relaxed both shoulders. Breath in for 4 second, Hold breath for 4 sec, Breath out for 4 sec, Hold for 4 sec, Inhalations and exhalations move a 3D cloud shaped object closer and farther away from the user. 2. LAMINAL VR (Calm): Inhalations and exhalations grow and shrink a 2D circle with bubbles in between, changing in color.

  • Buteyko Breathing

    Procedure/Surgery

    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 for 4 min. Wait 2 min and take Control pause. Reduced breathing for 4 min. Wait 2 min and take Control pause.

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Buteyko breathing exercise groupActive comparator 1 intervention
Group B: Virtual Reality groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Control pause breathing test

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.

Time frame
8 weeks
2

Asthma control test

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

Time frame
8 weeks
3

Forced Expiratory Volume in one second (FEV1)

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.

Time frame
8 weeks
4

Forced vital capacity (FVC)

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

Time frame
8 weeks

Secondary outcomes

1

Treatment Adherence Perception Questionnaire(TAPQ)

It is a new, brief self-report instrument for assessing patient perceptions and attitudes regarding their own adherence to medical treatment plans. It consists of three distinct scales: Perceived Behavior, Perceived Benefit, and Perceived Burden. Each scale is scored using a Likert-type scale, and higher scores generally indicate more positive perceptions of adherence. Each scale typically contains a set number of items (e.g., 5 items). These items are rated on a Likert-type scale, such as:1 = Strongly Disagree, 2 = Disagree, 3 = Uncertain, 4 = Agree, 5 = Strongly Agree. The scores for each item within a scale are summed to produce a total score for that scale.

Time frame
8 weeks
2

Functional capacity

It is measured by the 6-minute walk test; it is a simple, standardized assessment of functional exercise capacity, particularly useful for individuals with cardiopulmonary conditions. It measures the distance a patient can walk in six minutes, providing insights into their overall exercise tolerance and response to exertion. Less than 3 minutes walking or associated symptoms like fatigue, pain, or dyspnea indicate reduced functional capacity.

Time frame
8 weeks
3

Frequency of exacerbations (time/day)

It can refer to how often asthma exacerbation occurs within a single day. exacerbations are defined as worsening symptoms of breathlessness, cough, and/or sputum production, and they can be triggered by various factors like infections or air pollution. Frequent exacerbations are a hallmark of severe asthma and can significantly impact a patient's quality of life.

Time frame
8 weeks

Other outcomes

Locations

1

Map coordinates are unavailable for these locations. Locations are shown below instead.

October 6 university hospital outpatient chest department Status unavailable 12555, Giza, Cairo GovernorateEgyptEgypt

Sponsors and contacts

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