AzTrials
AzTrials

AsthmaNCT07141212

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

A study testing Virtual reality glass and Buteyko Breathing in people with Asthma, run by October 6 University at 1 site in Egypt.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 30 to 40 years
Conditions the study is for
Asthma
What is being tested?
Virtual reality glass and Buteyko Breathing
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteEgypt
Study dates
30 Aug 2025to Mar 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 40 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Mai G Abdelrahman, AS Lecturer contact

+201092018685

mai.gomaa.pt@o6u.edu.eg

Donia M El Masry, Lecturer contact

+201005587119

Egypt1 site
  • October 6 university hospital outpatient chest department

    Giza, Cairo Governorate, 12555

    Karim A Fathy, Professor, +201000011396, K_fathy.pt@o6u.edu.eg

Other trials in Egypt

About this study

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.

Read the detailed description

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?

Conditions
Asthma
Being tested
Virtual reality glass, Buteyko Breathing
Medical subject headings
Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Virtual reality glassDevice

    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 BreathingProcedure or 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.

Study groups in NCT07141212
Study groupRoleWhat they receive
Buteyko breathing exercise groupActive comparatorThe 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
Receives: Procedure: Buteyko Breathing
Virtual Reality groupExperimentalThe 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).
Receives: Device: Virtual reality glass

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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

    Measured: 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.

    Measured: 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

    Measured: 8 weeks

  5. FEV1/FVC ratio

    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

    Measured: 8 weeks

  6. Peak expiratory flow (% predicted)

    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.

    Measured: 8 weeks

  7. Anxiety level by Hospital Anxiety and Depression Scale (HADS)

    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.

    Measured: 8 weeks

Secondary outcomes (3)
  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.

    Measured: 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.

    Measured: 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.

    Measured: 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Aug 2025
  2. Study start30 Aug 2025 (estimated)
  3. Primary completionDec 2025 (estimated)
  4. Study completionMar 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07141212
Sponsor's protocol ID
Virtual Reality in Asthma
Status last verified
Aug 2025
First submitted
22 Jul 2025
Last updated
26 Aug 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 34962159

Questions about this trial

What is this clinical trial studying?

A study testing Virtual reality glass and Buteyko Breathing in people with Asthma, run by October 6 University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 26 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Mai G Abdelrahman, AS Lecturer (+201092018685, mai.gomaa.pt@o6u.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Control pause breathing test (time frame: 8 weeks). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07141212, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2025.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in