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

NCT ID: NCT05692557

Last Updated: 2023-01-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-01
• Study Completion Date: 2022-12-31

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.

Conditions

Burns Chest Left Lateral; Burns Chest Right Lateral; Acute Respiratory Distress Syndrome

Study Design

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

Study Groups

Virtual reality distraction and chest physiotherapy

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

Group Type: EXPERIMENTAL

Virtual reality

Intervention Type: 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 relaxation exercise and chest physiotherapy

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

Group Type: ACTIVE_COMPARATOR

Progressive muscle relaxation

Intervention Type: 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.

Interventions

Virtual reality

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.

Intervention Type: DEVICE

Progressive muscle relaxation

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.

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Prince Sattam Bin Abdulaziz University

OTHER

Sponsor Role: lead

Responsible Party

Gopal Nambi

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gopal Nambi, PhD

Role: PRINCIPAL_INVESTIGATOR

Prince Sattam Bin Abdulaziz University

Locations

Dr. Gopal Nambi

Al Kharj, Riyadh Region, Saudi Arabia

Countries

Saudi Arabia

Other Identifiers

RHPT/020/087

Identifier Type: -

Identifier Source: org_study_id