Virtual Reality on Pain and Range of Motion on Burn

Not Applicable

Completed

• Conditions: Burns
• Interventions: Device: active assisted exercise and with fully immersive Head-Mounted Display virtual reality ( Oculus Quest virtual reality (VR) headset with hand con; Other: active assisted range of motion exercise

• Registration Number: NCT05352711
• Lead Sponsor: Cairo University

Brief Summary

The Purpose of the study is to determine the effect of virtual reality exercise on pain and shoulder range of motion in pediatrics with 2nd-degree anterior shoulder burn injuries.

Detailed Description

Burns are an important cause of injury to young children, being the third most frequent cause of injury resulting in death behind motor vehicle accidents and drowning. Burn injuries account for the greatest length of stay of all hospital admissions for injuries and costs associated with care are substantial. The majority of burn injuries in children are scald injuries resulting from hot liquids, occurring most commonly in children aged 0-4 years. Other types of burns include electrical, chemical and intentional injury. Mechanisms of injury are often unique to children and involve exploratory behavior without the requisite comprehension of the dangers in their environment.

Immersive virtual reality (VR) is a new form of cognitive distraction and has been found to be an effective adjunctive, nonpharmacologic analgesic for postburn physical therapy. The VR gives the individual the illusion of "going into" the 3-dimensional computer generated environment, as if it were a place in which they are actually physically present. The strength of the presence is thought to reflect the amount of attention that is drawn into the virtual world. Because VR is a highly attention-grabbing experience, it can be an effective psychological pain control technique. Less attention to pain can result in reductions in pain intensity, unpleasantness, and the amount of time patients spend thinking about their pain.

Study Timeline

• Study First Submitted: 2022-04-13
• Study Start: 2022-04-20
• Study First Submitted QC: 2022-04-26
• Study First Posted: 2022-04-29
• Primary Completion: 2023-05-30
• Study Completion: 2023-06-30
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-06
• Last Update Posted: 2024-02-07

Recruitment & Eligibility

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

Inclusion Criteria

• Age range between 9-16 years.
• Both sexes will participate in the study.
• Patients who suffered from anterior shoulder burns with involvement of axillary fold.
• patient who suffered from second degree burns.
• all patients are acute cases .

Exclusion Criteria

• injuries to the face or head
• Injuries in hands
• Cognitive impairment
• A history of severe motion sickness
• Mental health problems.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
active assisted exercise with Oculus Quest virtual reality (VR) group	active assisted exercise and with fully immersive Head-Mounted Display virtual reality ( Oculus Quest virtual reality (VR) headset with hand con	This group includes 30 patients suffered from pain and loss of shoulder flexion ROM, The patients will treated with active assisted exercise and with fully immersive Head-Mounted Display virtual reality ( Oculus Quest virtual reality (VR) headset with hand controller ) for 30 min. 2 times per week for 4 weeks The ROM will be assessed by mobile goniometer application and Smart phone version of visual analogue scale (VAS) to assess pain and The Quality-of-Life Scale for Children to assess the psychometric properties after the 1st session, day 14 and day 28.
active assisted range of motion exercise group	active assisted range of motion exercise	This group includes 30 patients suffering from pain and loss of shoulder flexion ROM. Patients will recieve active-assisted ROM physical therapy 2 sessions per week for 4 weeks.

Primary Outcome Measures

Name	Time	Method
change of ROM for shoulder flexion assessment in day 28	Goniometer record apps was used to measure shoulder flexion range of movement (ROM) in day 28	mobile applications (apps) specifically designed to measure ROM
change of ROM for shoulder flexion assessment in day 14	Goniometer record apps was used to measure shoulder flexion range of movement (ROM) in day 14	mobile applications (apps) specifically designed to measure ROM
status of ROM for shoulder flexion assessment in day 1	Goniometer record apps was used to measure shoulder flexion range of movement (ROM) in day 1	mobile applications (apps) specifically designed to measure ROM
status of shoulder pain assessment in day 1	evaluate psychometric properties within the distinct targeted samples in day 1	Smart phone version of visual analogue scale (VAS) for assessing the pain ,the user touches the line, marking the location along the line that indicates the severity of the pain. An integer score between 0 and 100 is calculated based on the location of the marker relative to the ends of the line.(0 indicates no pain while 100 indicates worest pain)
change of shoulder pain assessment in day 14	evaluate psychometric properties within the distinct targeted samples in day 14	Smart phone version of visual analogue scale (VAS) for assessing the pain ,the user touches the line, marking the location along the line that indicates the severity of the pain. An integer score between 0 and 100 is calculated based on the location of the marker relative to the ends of the line.(0 indicates no pain while 100 indicates worest pain)
change of shoulder pain assessment in day 28	evaluate psychometric properties within the distinct targeted samples in day 28	Smart phone version of visual analogue scale (VAS) for assessing the pain ,the user touches the line, marking the location along the line that indicates the severity of the pain. An integer score between 0 and 100 is calculated based on the location of the marker relative to the ends of the line. (0 indicates no pain while 100 indicates worest pain)

Secondary Outcome Measures

Name	Time	Method
change in presentation of an individual's perception of their current health state	this questionnaire will be used to asses the quality of patient's life at the day 28 of treatment	Quality-of-Life Scale from 0 to 10 (0 is the worst health you could imagine. 10 is the best health you could imagine)
presentation of an individual's perception of their current health state	questionnaire is used to asses the quality of patient's life at the first day of treatment	Quality-of-Life Scale from 0 to 10 (0 is the worst health you could imagine. 10 is the best health you could imagine)

Trial Locations

Locations (1)

Ahmed Orabi hospital for burn and tumors; 🇪🇬 Cairo, Egypt