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

NCT05692557 | Completed DMC

• 1 other identifier: RHPT/020/087
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (36)

• Pulmonary function test - forced vital capacity (FVC)

  Baseline

• Pulmonary function test - forced vital capacity (FVC)

  4 weeks

• Pulmonary function test - forced vital capacity (FVC)

  8 weeks

• Pulmonary function test - forced vital capacity (FVC)

  6 months

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

  Baseline

Study Arms (2)

Virtual reality distraction and chest physiotherapy

EXPERIMENTAL

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

Progressive relaxation exercise and chest physiotherapy

ACTIVE COMPARATOR

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

Interventions

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.

Virtual reality distraction and chest physiotherapy

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.

Progressive relaxation exercise and chest physiotherapy

Eligibility Criteria

• Age: 35 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Prince Sattam Bin Abdulaziz University: lead

Study Sites (1)

Dr. Gopal Nambi

Al Kharj, Riyadh Region, 11942, Saudi Arabia

Location

MeSH Terms

Conditions

Respiratory Distress Syndrome

Interventions

Autogenic Training

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Intervention Hierarchy (Ancestors)

Hypnosis; Mind-Body Therapies; Complementary Therapies; Therapeutics; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Gopal Nambi, PhD

  Prince Sattam Bin Abdulaziz University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The participants were not aware of which treatment they were receiving (blind participants); however, they were informed that they would receive one of the two interventions. Due to the nature of the interventions, it was not possible to blind the therapist who treated the patients.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: January 11, 2023
• First Posted: January 20, 2023
• Study Start: September 1, 2020
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: January 20, 2023

Record last verified: 2023-01

Locations

SA (1)