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Completed

NCT Number: NCT05692557

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

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.

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Key information

Conditions

Burns Chest Left Lateral Acute Respiratory Distress Syndrome Burns Chest Right Lateral Lung Diseases Respiration Disorders Respiratory Distress Syndrome Respiratory Tract Diseases

Age range

35 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dr. Gopal Nambi

Al Kharj, Riyadh Region, 11942, Saudi Arabia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Virtual reality

Device

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.

Progressive muscle relaxation

Procedure

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.

Primary outcomes

  1. Pain intensity - Visual analog scale (VAS)

    Time frame: Baseline

    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.

  2. Pain intensity - Visual analog scale (VAS)

    Time frame: 4 weeks

    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.

  3. Pain intensity - Visual analog scale (VAS)

    Time frame: 8 weeks

    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. Pain intensity - Visual analog scale (VAS)

    Time frame: 6 months

    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.

Secondary outcomes

  1. Pulmonary function test - forced vital capacity (FVC)

    Time frame: Baseline

    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.

  2. Pulmonary function test - forced vital capacity (FVC)

    Time frame: 4 weeks

    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.

  3. Pulmonary function test - forced vital capacity (FVC)

    Time frame: 8 weeks

    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. Pulmonary function test - forced vital capacity (FVC)

    Time frame: 6 months

    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.

  5. Pulmonary function test - forced expiratory volume in 1 second (FEV1)

    Time frame: Baseline

    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. Pulmonary function test - forced expiratory volume in 1 second (FEV1)

    Time frame: 4 weeks

    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.

  7. Pulmonary function test - forced expiratory volume in 1 second (FEV1)

    Time frame: 8 weeks

    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. Pulmonary function test - forced expiratory volume in 1 second (FEV1)

    Time frame: 6 months

    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.

  9. Pulmonary function test - FEV1/FVC

    Time frame: Baseline

    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.

  10. Pulmonary function test - FEV1/FVC

    Time frame: 4 weeks

    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.

  11. Pulmonary function test - FEV1/FVC

    Time frame: 8 weeks

    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.

  12. Pulmonary function test - FEV1/FVC

    Time frame: 6 months

    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.

  13. Pulmonary function test - peak expiratory flow (PEF)

    Time frame: Baseline

    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.

  14. Pulmonary function test - peak expiratory flow (PEF)

    Time frame: 4 weeks

    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.

  15. Pulmonary function test - peak expiratory flow (PEF)

    Time frame: 8 weeks

    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.

  16. Pulmonary function test - peak expiratory flow (PEF)

    Time frame: 6 months

    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.

  17. Pulmonary function test - residual volume (RV)

    Time frame: Baseline

    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.

  18. Pulmonary function test - residual volume (RV)

    Time frame: 4 weeks

    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.

  19. Pulmonary function test - residual volume (RV)

    Time frame: 8 weeks

    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.

  20. Pulmonary function test - residual volume (RV)

    Time frame: 6 months

    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.

  21. Pulmonary function test - functional residual capacity (FRC)

    Time frame: Baseline

    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.

  22. Pulmonary function test - functional residual capacity (FRC)

    Time frame: 4 weeks

    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.

  23. Pulmonary function test - functional residual capacity (FRC)

    Time frame: 8 weeks

    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.

  24. Pulmonary function test - functional residual capacity (FRC)

    Time frame: 6 months

    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.

  25. Pulmonary function test - total lung capacity (TLC)

    Time frame: Baseline

    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.

  26. Pulmonary function test - total lung capacity (TLC)

    Time frame: 4 weeks

    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.

  27. Pulmonary function test - total lung capacity (TLC)

    Time frame: 8 weeks

    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.

  28. Pulmonary function test - total lung capacity (TLC)

    Time frame: 6 months

    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.

  29. Pulmonary function test - RV/TLC

    Time frame: Baseline

    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.

  30. Pulmonary function test - RV/TLC

    Time frame: 4 weeks

    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.

  31. Pulmonary function test - RV/TLC

    Time frame: 8 weeks

    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.

  32. Pulmonary function test - RV/TLC

    Time frame: 6 months

    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.

  33. Pulmonary function test - diffusing capacity for carbon monoxide of the lungs (DLCO)

    Time frame: Baseline

    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.

  34. Pulmonary function test - diffusing capacity for carbon monoxide of the lungs (DLCO)

    Time frame: 4 weeks

    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.

  35. Pulmonary function test - diffusing capacity for carbon monoxide of the lungs (DLCO)

    Time frame: 8 weeks

    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.

  36. Pulmonary function test - diffusing capacity for carbon monoxide of the lungs (DLCO)

    Time frame: 6 months

    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.

Sponsors and collaborators

Lead sponsor

Prince Sattam Bin Abdulaziz University

Other

Registry information

Official study title

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.

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jan 20, 2023
Registry last updated
Jan 20, 2023

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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