Virtual Reality Distraction Technique to Improve Chest Burns With Acute Respiratory Distress Syndrome

Study Overview
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Brief Summary
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Inhalation of toxic gases and chemical irritants during the fire leads to damage to the respiratory tract or the alveolar tissue, which is known as smoke inhalation injury. Acute Respiratory Distress Syndrome (ARDS) is associated with smoke inhalation injury. These patients usually need physiotherapy in the form of chest mobilization and breathing exercises for up to 4 to 6 weeks after discharge from the burns care centre. The patients during this phase are usually in pain and extremely anxious about these exercises. Virtual reality distraction (VRD) is one such technique that is gaining immense popularity recently, it has more immersive distraction when compared to traditional distraction techniques. This study aims to investigate the effect of a virtual reality distraction (VRD) technique as a pain alleviation tool for reducing pain during physiotherapy in burns patients with acute respiratory distress syndrome (ARDS) in a hospital setting.

Detailed Description
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Burns of the chest region (Chest burns - CB) constitute a common burn (29%) among other types of burn, in which second and third-degree burns are the most common type of injuries noted. Additionally, inhalation of toxic gases and chemical irritants during the fire leads to damage to the respiratory tract or the alveolar tissue, which is known as smoke inhalation injury. Acute Respiratory Distress Syndrome (ARDS) is associated with smoke inhalation injury, which is one of the infectious complications after a burn injury. According to the present data, the incidence of ARDS in burn patients is about 20 - 56% and is one of the main causes of death among burn patients. Management of ARDS generally includes mechanical ventilation, prophylaxis treatment, proper diet and physiotherapy treatment. These patients usually need physiotherapy in the form of chest mobilization and breathing exercises for up to 4 to 6 weeks after discharge from the burns care centre. The patients during this phase are usually in pain and extremely anxious about these exercises, hence pain and anti-anxiety drugs may be prescribed. Virtual reality distraction (VRD) is one such technique that is gaining immense popularity recently, it has more immersive distraction when compared to traditional distraction techniques like inhibition exercises, meditation or progressive muscle relaxation exercises. This study aims to investigate the effect of a virtual reality distraction (VRD) technique as a pain alleviation tool for reducing pain during physiotherapy in burns patients with acute respiratory distress syndrome (ARDS) in a hospital setting.

Official Title
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Role of Virtual Reality Distraction Technique to Improve Chest Burns With Acute Respiratory Distress Syndrome (ARDS) Following Smoke Inhalation in Community-dwelling Middle-aged Adults - A Randomized Controlled Study.

Conditions
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Burns Chest Left Lateral, Burns Chest Right Lateral, Acute Respiratory Distress Syndrome

Intervention / Treatment
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* Device: Virtual reality
* Procedure: Progressive muscle relaxation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Community-dwelling middle-aged adult patients (aged between 35 - 55 years) with chest burn injury and moderate ARDS who were to receive physiotherapy at home for at least 1 month were invited to participate. The clinical diagnosis of ARDS (International Classiﬁcation of Diseases 10th revision [ICD-10] group J80) was diagnosed according to Berlin diagnostic criteria by a general physician. The baseline pain intensities 3 to 8 on the visual analogue scale (VAS) were included. Exclusion Criteria: Any injury that would hinder the outcome of the study procedures, patients who had difficulty in communication due to impaired hearing, visual or motor development, who had a history of epilepsy, migraine or motion sickness, and participants who were suspected victims of abuse.

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This trial was a randomized, parallel-group, clinical controlled trial conducted at the department of health and rehabilitation sciences, college of applied medical sciences, Prince Sattam bin Abdulaziz University, Al Kharj, Saudi Arabia.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Virtual reality distraction and chest physiotherapy<br>Virtual reality distraction: The Oculus Rift's Fujii - Mystical Journey was a game played by the Virtual reality distraction group on a tablet. The game is a peaceful, ethereal voyage that passes through several surreal, natural locations. The game combines elements of adventure, agriculture and revitalizing music. It alternates between outdoor exploration and inventive gardening. Players explore three different magical biomes. The life force in each biome is restored by interacting with the plants and animals there. Before beginning the chest physical therapy, the patients had 15 minutes to play this computer game | Device: Virtual reality<br>* The Oculus Rift's (Lenovo, Beijing, China) Fujii - Mystical Journey was the game played by the VRD group on a tablet. The game is a peaceful, ethereal voyage that passes through several surreal, natural locations. The game combines elements of adventure, agriculture and revitalizing music. It alternates between outdoor exploration and inventive gardening. Players explore three different magical biomes. The life force in each biome is restored by interacting with the plants and animals there.<br>|
| Active Comparator: Progressive relaxation exercise and chest physiotherapy<br>Progressive muscle relaxation: The patients of the control group performed the Progressive muscle relaxation technique, a relaxation technique used to control pain. It is believed that anxiety-inducing thoughts result in muscle tension and hence muscle relaxation can reduce anxiety. The relaxation technique consisted of tensing and relaxing different muscles, starting from the toes and finally involving muscles of the head and neck. It was recommended that this be done in a peaceful, distraction-free environment. The muscle groups were tensed for a period of 5 seconds and then relaxed for 30 seconds, the process was repeated for a period of 15 minutes | Procedure: Progressive muscle relaxation<br>* The patients of the control group performed Progressive muscle relaxation technique, a relaxation technique used to control pain. It is believed that anxiety-inducing thoughts result in muscle tension and hence muscle relaxation can reduce anxiety. The relaxation technique consisted of tensing and relaxing different muscles, starting from the toes and finally involving muscles of the head and neck. It was recommended that this be done in a peaceful, distraction-free environment. The muscle groups were tensed for a period of 5 seconds and then relaxed for 30 seconds.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain intensity - Visual analog scale (VAS) | The participants were asked to mark their level of pain intensity between 0 and 10, in which '0' denotes no pain at all and '10' denotes the worst pain ever possible. It is a reliable and valid tool to assess pain intensity as proven by studies and a 2-point change or response in the NPRS is considered a clinically meaningful change that exceeds measurement error. | Baseline | 
| Pain intensity - Visual analog scale (VAS) | The participants were asked to mark their level of pain intensity between 0 and 10, in which '0' denotes no pain at all and '10' denotes the worst pain ever possible. It is a reliable and valid tool to assess pain intensity as proven by studies and a 2-point change or response in the NPRS is considered a clinically meaningful change that exceeds measurement error. | 4 weeks | 
| Pain intensity - Visual analog scale (VAS) | The participants were asked to mark their level of pain intensity between 0 and 10, in which '0' denotes no pain at all and '10' denotes the worst pain ever possible. It is a reliable and valid tool to assess pain intensity as proven by studies and a 2-point change or response in the NPRS is considered a clinically meaningful change that exceeds measurement error. | 8 weeks | 
| Pain intensity - Visual analog scale (VAS) | The participants were asked to mark their level of pain intensity between 0 and 10, in which '0' denotes no pain at all and '10' denotes the worst pain ever possible. It is a reliable and valid tool to assess pain intensity as proven by studies and a 2-point change or response in the NPRS is considered a clinically meaningful change that exceeds measurement error. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pulmonary function test - forced vital capacity (FVC) | Pulmonary function test (PFT) was undertaken to determine the degree of functional impairment and was performed with spirometer (MasterScreen Body; Jaeger, Wurzburg, Germany). The lung functions were determined by blowing through the mouth piece in the spirometer. The test was repeated three times or more and average score was considered, and all values were expressed as a percentage of the predicted values. | Baseline | 
| Pulmonary function test - forced vital capacity (FVC) | Pulmonary function test (PFT) was undertaken to determine the degree of functional impairment and was performed with spirometer (MasterScreen Body; Jaeger, Wurzburg, Germany). The lung functions were determined by blowing through the mouth piece in the spirometer. The test was repeated three times or more and average score was considered, and all values were expressed as a percentage of the predicted values. | 4 weeks | 
| Pulmonary function test - forced vital capacity (FVC) | Pulmonary function test (PFT) was undertaken to determine the degree of functional impairment and was performed with spirometer (MasterScreen Body; Jaeger, Wurzburg, Germany). The lung functions were determined by blowing through the mouth piece in the spirometer. The test was repeated three times or more and average score was considered, and all values were expressed as a percentage of the predicted values. | 8 weeks | 
| Pulmonary function test - forced vital capacity (FVC) | Pulmonary function test (PFT) was undertaken to determine the degree of functional impairment and was performed with spirometer (MasterScreen Body; Jaeger, Wurzburg, Germany). The lung functions were determined by blowing through the mouth piece in the spirometer. The test was repeated three times or more and average score was considered, and all values were expressed as a percentage of the predicted values. | 6 months | 
| Pulmonary function test - forced expiratory volume in 1 second (FEV1) | Pulmonary function test (PFT) was undertaken to determine the degree of functional impairment and was performed with spirometer (MasterScreen Body; Jaeger, Wurzburg, Germany). The lung functions were determined by blowing through the mouth piece in the spirometer. The test was repeated three times or more and average score was considered, and all values were expressed as a percentage of the predicted values. | Baseline | 
| Pulmonary function test - forced expiratory volume in 1 second (FEV1) | Pulmonary function test (PFT) was undertaken to determine the degree of functional impairment and was performed with spirometer (MasterScreen Body; Jaeger, Wurzburg, Germany). The lung functions were determined by blowing through the mouth piece in the spirometer. The test was repeated three times or more and average score was considered, and all values were expressed as a percentage of the predicted values. | 4 weeks | 
| Pulmonary function test - forced expiratory volume in 1 second (FEV1) | Pulmonary function test (PFT) was undertaken to determine the degree of functional impairment and was performed with spirometer (MasterScreen Body; Jaeger, Wurzburg, Germany). The lung functions were determined by blowing through the mouth piece in the spirometer. The test was repeated three times or more and average score was considered, and all values were expressed as a percentage of the predicted values. | 8 weeks | 
| Pulmonary function test - forced expiratory volume in 1 second (FEV1) | Pulmonary function test (PFT) was undertaken to determine the degree of functional impairment and was performed with spirometer (MasterScreen Body; Jaeger, Wurzburg, Germany). The lung functions were determined by blowing through the mouth piece in the spirometer. The test was repeated three times or more and average score was considered, and all values were expressed as a percentage of the predicted values. | 6 months | 
| Pulmonary function test - FEV1/FVC | Pulmonary function test (PFT) was undertaken to determine the degree of functional impairment and was performed with spirometer (MasterScreen Body; Jaeger, Wurzburg, Germany). The lung functions were determined by blowing through the mouth piece in the spirometer. The test was repeated three times or more and average score was considered, and all values were expressed as a percentage of the predicted values. | Baseline | 
| Pulmonary function test - FEV1/FVC | Pulmonary function test (PFT) was undertaken to determine the degree of functional impairment and was performed with spirometer (MasterScreen Body; Jaeger, Wurzburg, Germany). The lung functions were determined by blowing through the mouth piece in the spirometer. The test was repeated three times or more and average score was considered, and all values were expressed as a percentage of the predicted values. | 4 weeks | 
| Pulmonary function test - FEV1/FVC | Pulmonary function test (PFT) was undertaken to determine the degree of functional impairment and was performed with spirometer (MasterScreen Body; Jaeger, Wurzburg, Germany). The lung functions were determined by blowing through the mouth piece in the spirometer. The test was repeated three times or more and average score was considered, and all values were expressed as a percentage of the predicted values. | 8 weeks | 
| Pulmonary function test - FEV1/FVC | Pulmonary function test (PFT) was undertaken to determine the degree of functional impairment and was performed with spirometer (MasterScreen Body; Jaeger, Wurzburg, Germany). The lung functions were determined by blowing through the mouth piece in the spirometer. The test was repeated three times or more and average score was considered, and all values were expressed as a percentage of the predicted values. | 6 months | 
| Pulmonary function test - peak expiratory flow (PEF) | Pulmonary function test (PFT) was undertaken to determine the degree of functional impairment and was performed with spirometer (MasterScreen Body; Jaeger, Wurzburg, Germany). The lung functions were determined by blowing through the mouth piece in the spirometer. The test was repeated three times or more and average score was considered, and all values were expressed as a percentage of the predicted values. | Baseline | 
| Pulmonary function test - peak expiratory flow (PEF) | Pulmonary function test (PFT) was undertaken to determine the degree of functional impairment and was performed with spirometer (MasterScreen Body; Jaeger, Wurzburg, Germany). The lung functions were determined by blowing through the mouth piece in the spirometer. The test was repeated three times or more and average score was considered, and all values were expressed as a percentage of the predicted values. | 4 weeks | 
| Pulmonary function test - peak expiratory flow (PEF) | Pulmonary function test (PFT) was undertaken to determine the degree of functional impairment and was performed with spirometer (MasterScreen Body; Jaeger, Wurzburg, Germany). The lung functions were determined by blowing through the mouth piece in the spirometer. The test was repeated three times or more and average score was considered, and all values were expressed as a percentage of the predicted values. | 8 weeks | 
| Pulmonary function test - peak expiratory flow (PEF) | Pulmonary function test (PFT) was undertaken to determine the degree of functional impairment and was performed with spirometer (MasterScreen Body; Jaeger, Wurzburg, Germany). The lung functions were determined by blowing through the mouth piece in the spirometer. The test was repeated three times or more and average score was considered, and all values were expressed as a percentage of the predicted values. | 6 months | 
| Pulmonary function test - residual volume (RV) | Pulmonary function test (PFT) was undertaken to determine the degree of functional impairment and was performed with spirometer (MasterScreen Body; Jaeger, Wurzburg, Germany). The lung functions were determined by blowing through the mouth piece in the spirometer. The test was repeated three times or more and average score was considered, and all values were expressed as a percentage of the predicted values. | Baseline | 
| Pulmonary function test - residual volume (RV) | Pulmonary function test (PFT) was undertaken to determine the degree of functional impairment and was performed with spirometer (MasterScreen Body; Jaeger, Wurzburg, Germany). The lung functions were determined by blowing through the mouth piece in the spirometer. The test was repeated three times or more and average score was considered, and all values were expressed as a percentage of the predicted values. | 4 weeks | 
| Pulmonary function test - residual volume (RV) | Pulmonary function test (PFT) was undertaken to determine the degree of functional impairment and was performed with spirometer (MasterScreen Body; Jaeger, Wurzburg, Germany). The lung functions were determined by blowing through the mouth piece in the spirometer. The test was repeated three times or more and average score was considered, and all values were expressed as a percentage of the predicted values. | 8 weeks | 
| Pulmonary function test - residual volume (RV) | Pulmonary function test (PFT) was undertaken to determine the degree of functional impairment and was performed with spirometer (MasterScreen Body; Jaeger, Wurzburg, Germany). The lung functions were determined by blowing through the mouth piece in the spirometer. The test was repeated three times or more and average score was considered, and all values were expressed as a percentage of the predicted values. | 6 months | 
| Pulmonary function test - functional residual capacity (FRC) | Pulmonary function test (PFT) was undertaken to determine the degree of functional impairment and was performed with spirometer (MasterScreen Body; Jaeger, Wurzburg, Germany). The lung functions were determined by blowing through the mouth piece in the spirometer. The test was repeated three times or more and average score was considered, and all values were expressed as a percentage of the predicted values. | Baseline | 
| Pulmonary function test - functional residual capacity (FRC) | Pulmonary function test (PFT) was undertaken to determine the degree of functional impairment and was performed with spirometer (MasterScreen Body; Jaeger, Wurzburg, Germany). The lung functions were determined by blowing through the mouth piece in the spirometer. The test was repeated three times or more and average score was considered, and all values were expressed as a percentage of the predicted values. | 4 weeks | 
| Pulmonary function test - functional residual capacity (FRC) | Pulmonary function test (PFT) was undertaken to determine the degree of functional impairment and was performed with spirometer (MasterScreen Body; Jaeger, Wurzburg, Germany). The lung functions were determined by blowing through the mouth piece in the spirometer. The test was repeated three times or more and average score was considered, and all values were expressed as a percentage of the predicted values. | 8 weeks | 
| Pulmonary function test - functional residual capacity (FRC) | Pulmonary function test (PFT) was undertaken to determine the degree of functional impairment and was performed with spirometer (MasterScreen Body; Jaeger, Wurzburg, Germany). The lung functions were determined by blowing through the mouth piece in the spirometer. The test was repeated three times or more and average score was considered, and all values were expressed as a percentage of the predicted values. | 6 months | 
| Pulmonary function test - total lung capacity (TLC) | Pulmonary function test (PFT) was undertaken to determine the degree of functional impairment and was performed with spirometer (MasterScreen Body; Jaeger, Wurzburg, Germany). The lung functions were determined by blowing through the mouth piece in the spirometer. The test was repeated three times or more and average score was considered, and all values were expressed as a percentage of the predicted values. | Baseline | 
| Pulmonary function test - total lung capacity (TLC) | Pulmonary function test (PFT) was undertaken to determine the degree of functional impairment and was performed with spirometer (MasterScreen Body; Jaeger, Wurzburg, Germany). The lung functions were determined by blowing through the mouth piece in the spirometer. The test was repeated three times or more and average score was considered, and all values were expressed as a percentage of the predicted values. | 4 weeks | 
| Pulmonary function test - total lung capacity (TLC) | Pulmonary function test (PFT) was undertaken to determine the degree of functional impairment and was performed with spirometer (MasterScreen Body; Jaeger, Wurzburg, Germany). The lung functions were determined by blowing through the mouth piece in the spirometer. The test was repeated three times or more and average score was considered, and all values were expressed as a percentage of the predicted values. | 8 weeks | 
| Pulmonary function test - total lung capacity (TLC) | Pulmonary function test (PFT) was undertaken to determine the degree of functional impairment and was performed with spirometer (MasterScreen Body; Jaeger, Wurzburg, Germany). The lung functions were determined by blowing through the mouth piece in the spirometer. The test was repeated three times or more and average score was considered, and all values were expressed as a percentage of the predicted values. | 6 months | 
| Pulmonary function test - RV/TLC | Pulmonary function test (PFT) was undertaken to determine the degree of functional impairment and was performed with spirometer (MasterScreen Body; Jaeger, Wurzburg, Germany). The lung functions were determined by blowing through the mouth piece in the spirometer. The test was repeated three times or more and average score was considered, and all values were expressed as a percentage of the predicted values. | Baseline | 
| Pulmonary function test - RV/TLC | Pulmonary function test (PFT) was undertaken to determine the degree of functional impairment and was performed with spirometer (MasterScreen Body; Jaeger, Wurzburg, Germany). The lung functions were determined by blowing through the mouth piece in the spirometer. The test was repeated three times or more and average score was considered, and all values were expressed as a percentage of the predicted values. | 4 weeks | 
| Pulmonary function test - RV/TLC | Pulmonary function test (PFT) was undertaken to determine the degree of functional impairment and was performed with spirometer (MasterScreen Body; Jaeger, Wurzburg, Germany). The lung functions were determined by blowing through the mouth piece in the spirometer. The test was repeated three times or more and average score was considered, and all values were expressed as a percentage of the predicted values. | 8 weeks | 
| Pulmonary function test - RV/TLC | Pulmonary function test (PFT) was undertaken to determine the degree of functional impairment and was performed with spirometer (MasterScreen Body; Jaeger, Wurzburg, Germany). The lung functions were determined by blowing through the mouth piece in the spirometer. The test was repeated three times or more and average score was considered, and all values were expressed as a percentage of the predicted values. | 6 months | 
| Pulmonary function test - diffusing capacity for carbon monoxide of the lungs (DLCO) | Pulmonary function test (PFT) was undertaken to determine the degree of functional impairment and was performed with spirometer (MasterScreen Body; Jaeger, Wurzburg, Germany). The lung functions were determined by blowing through the mouth piece in the spirometer. The test was repeated three times or more and average score was considered, and all values were expressed as a percentage of the predicted values. | Baseline | 
| Pulmonary function test - diffusing capacity for carbon monoxide of the lungs (DLCO) | Pulmonary function test (PFT) was undertaken to determine the degree of functional impairment and was performed with spirometer (MasterScreen Body; Jaeger, Wurzburg, Germany). The lung functions were determined by blowing through the mouth piece in the spirometer. The test was repeated three times or more and average score was considered, and all values were expressed as a percentage of the predicted values. | 4 weeks | 
| Pulmonary function test - diffusing capacity for carbon monoxide of the lungs (DLCO) | Pulmonary function test (PFT) was undertaken to determine the degree of functional impairment and was performed with spirometer (MasterScreen Body; Jaeger, Wurzburg, Germany). The lung functions were determined by blowing through the mouth piece in the spirometer. The test was repeated three times or more and average score was considered, and all values were expressed as a percentage of the predicted values. | 8 weeks | 
| Pulmonary function test - diffusing capacity for carbon monoxide of the lungs (DLCO) | Pulmonary function test (PFT) was undertaken to determine the degree of functional impairment and was performed with spirometer (MasterScreen Body; Jaeger, Wurzburg, Germany). The lung functions were determined by blowing through the mouth piece in the spirometer. The test was repeated three times or more and average score was considered, and all values were expressed as a percentage of the predicted values. | 6 months |