Clinical trial NCT05692557: Virtual Reality Distraction Technique to Improve Chest Burns With Acute Respiratory Distress Syndrome
Official 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Burns Chest Left Lateral
Burns Chest Right Lateral
Acute Respiratory Distress Syndrome
Lead sponsor: Prince Sattam Bin Abdulaziz University
Sponsor class: OTHER
First posted: 2023-01-20
Enrollment: 60
Sex: ALL
Minimum age (years): 35
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Pain intensity - Visual analog scale (VAS)
timeFrame: Baseline
measure: Pain intensity - Visual analog scale (VAS)
timeFrame: 4 weeks
measure: Pain intensity - Visual analog scale (VAS)
timeFrame: 8 weeks
measure: Pain intensity - Visual analog scale (VAS)
timeFrame: 6 months
Secondary outcomes:
measure: Pulmonary function test - forced vital capacity (FVC)
timeFrame: Baseline
measure: Pulmonary function test - forced vital capacity (FVC)
timeFrame: 4 weeks
measure: Pulmonary function test - forced vital capacity (FVC)
timeFrame: 8 weeks
measure: Pulmonary function test - forced vital capacity (FVC)
timeFrame: 6 months
measure: Pulmonary function test - forced expiratory volume in 1 second (FEV1)
timeFrame: Baseline
measure: Pulmonary function test - forced expiratory volume in 1 second (FEV1)
timeFrame: 4 weeks
measure: Pulmonary function test - forced expiratory volume in 1 second (FEV1)
timeFrame: 8 weeks
measure: Pulmonary function test - forced expiratory volume in 1 second (FEV1)
timeFrame: 6 months
measure: Pulmonary function test - FEV1/FVC
timeFrame: Baseline
measure: Pulmonary function test - FEV1/FVC
timeFrame: 4 weeks
measure: Pulmonary function test - FEV1/FVC
timeFrame: 8 weeks
measure: Pulmonary function test - FEV1/FVC
timeFrame: 6 months
measure: Pulmonary function test - peak expiratory flow (PEF)
timeFrame: Baseline
measure: Pulmonary function test - peak expiratory flow (PEF)
timeFrame: 4 weeks
measure: Pulmonary function test - peak expiratory flow (PEF)
timeFrame: 8 weeks
measure: Pulmonary function test - peak expiratory flow (PEF)
timeFrame: 6 months
measure: Pulmonary function test - residual volume (RV)
timeFrame: Baseline
measure: Pulmonary function test - residual volume (RV)
timeFrame: 4 weeks
measure: Pulmonary function test - residual volume (RV)
timeFrame: 8 weeks
measure: Pulmonary function test - residual volume (RV)
timeFrame: 6 months
measure: Pulmonary function test - functional residual capacity (FRC)
timeFrame: Baseline
measure: Pulmonary function test - functional residual capacity (FRC)
timeFrame: 4 weeks
measure: Pulmonary function test - functional residual capacity (FRC)
timeFrame: 8 weeks
measure: Pulmonary function test - functional residual capacity (FRC)
timeFrame: 6 months
measure: Pulmonary function test - total lung capacity (TLC)
timeFrame: Baseline
measure: Pulmonary function test - total lung capacity (TLC)
timeFrame: 4 weeks
measure: Pulmonary function test - total lung capacity (TLC)
timeFrame: 8 weeks
measure: Pulmonary function test - total lung capacity (TLC)
timeFrame: 6 months
measure: Pulmonary function test - RV/TLC
timeFrame: Baseline
measure: Pulmonary function test - RV/TLC
timeFrame: 4 weeks
measure: Pulmonary function test - RV/TLC
timeFrame: 8 weeks
measure: Pulmonary function test - RV/TLC
timeFrame: 6 months
measure: Pulmonary function test - diffusing capacity for carbon monoxide of the lungs (DLCO)
timeFrame: Baseline
measure: Pulmonary function test - diffusing capacity for carbon monoxide of the lungs (DLCO)
timeFrame: 4 weeks
measure: Pulmonary function test - diffusing capacity for carbon monoxide of the lungs (DLCO)
timeFrame: 8 weeks
measure: Pulmonary function test - diffusing capacity for carbon monoxide of the lungs (DLCO)
timeFrame: 6 months
Other outcomes:
Locations:
city: Al Kharj
country: Saudi Arabia
facility: Dr. Gopal Nambi
state: Riyadh
Study officials:
affiliation: Prince Sattam Bin Abdulaziz University
name: Gopal Nambi, PhD
role: PRINCIPAL_INVESTIGATOR
References: