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

NCT ID: NCT07141212

Last Updated: 2025-08-26

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-30
• Study Completion Date: 2026-03-31

Brief 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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

Buteyko Breathing

Intervention Type: PROCEDURE

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.

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).

Group Type: EXPERIMENTAL

Virtual reality glass

Intervention Type: 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.

Interventions

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 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.

Intervention Type: DEVICE

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

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

October 6 University

OTHER

Sponsor Role: lead

Responsible Party

Mai Gomaa Mohamed Abdelrahman

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Zahra M Serry, As Professor

Role: STUDY_CHAIR

Cairo University

Donia M El Masry, Lecturer

Role: STUDY_DIRECTOR

Cairo University

Karim A Fathy, Professor

Role: PRINCIPAL_INVESTIGATOR

Faculty of Physical therapy October 6 University

Amira I Alam Eldin, As Professor

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Locations

October 6 university hospital outpatient chest department

Giza, Cairo Governorate, Egypt

Countries

Egypt

Central Contacts

Mai G Abdelrahman, AS Lecturer

Role: CONTACT

mai.gomaa.pt@o6u.edu.eg

+201092018685

Donia M El Masry, Lecturer

Role: CONTACT

+201005587119

Facility Contacts

Karim A Fathy, Professor

Role: primary

K_fathy.pt@o6u.edu.eg

+201000011396

References

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.

Reference Type: BACKGROUND

PMID: 34962159 (View on PubMed)

Other Identifiers

Virtual Reality in Asthma

Identifier Type: -

Identifier Source: org_study_id