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

Not Applicable

Completed

• Conditions: Acute Respiratory Distress Syndrome; Burns Chest Right Lateral; Burns Chest Left Lateral

• Registration Number: NCT05692557
• Lead Sponsor: Prince Sattam Bin Abdulaziz University

Brief Summary

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

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.

Study Timeline

• Study Start: 2020-09-01
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31
• Status Verified: 2023-01
• Study First Submitted: 2023-01-11
• Study First Submitted QC: 2023-01-11
• Last Update Submitted: 2023-01-11
• Study First Posted: 2023-01-20
• Last Update Posted: 2023-01-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Pain intensity - Visual analog scale (VAS)	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 Outcome Measures

Name	Time	Method
Pulmonary function test - functional residual capacity (FRC)	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.
Pulmonary function test - forced vital capacity (FVC)	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.
Pulmonary function test - forced expiratory volume in 1 second (FEV1)	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.
Pulmonary function test - FEV1/FVC	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.
Pulmonary function test - peak expiratory flow (PEF)	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.
Pulmonary function test - residual volume (RV)	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.
Pulmonary function test - total lung capacity (TLC)	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.
Pulmonary function test - RV/TLC	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.
Pulmonary function test - diffusing capacity for carbon monoxide of the lungs (DLCO)	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.

Trial Locations

Locations (1)

Dr. Gopal Nambi; 🇸🇦 Al Kharj, Riyadh, Saudi Arabia