Virtual Reality on Pain and Range of Motion on Burn

Burns Clinical Trial

Official title:

Effect of Virtual Reality Exercise on Pain and Range of Motion in Pediatrics With Second Degree Anterior Shoulder Burn Injuries

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05352711
• Other study ID #: P.T.REC/012/003467
• Status: Completed
• Phase: N/A
• Start date: April 20, 2022
• Est. completion date: June 30, 2023

Study information

• Verified date: February 2024
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 30, 2023
• Est. primary completion date: May 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 9 Years to 16 Years

Eligibility

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.

Related Conditions & MeSH terms

• Burns

Intervention

Device:
• active assisted exercise and with fully immersive Head-Mounted Display virtual reality ( Oculus Quest virtual reality (VR) headset with hand con
VR is mainly created by generating visual effects through head-mounted display (HMD) systems. An HMD is a device worn on the head or as part of a helmet with a built-in display and lenses, allowing the user to experience the virtual world with the help of a wide viewing angle, head and hand movements tracking as well as objects interacting by controllers.

Other:
• active assisted range of motion exercise
Patients were treated active assisted ROM physical therapy 2 sessions per week for 4 weeks.

Locations

Country	Name	City	State
Egypt	Ahmed Orabi hospital for burn and tumors	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	status of ROM for shoulder flexion assessment in day 1	mobile applications (apps) specifically designed to measure ROM	Goniometer record apps was used to measure shoulder flexion range of movement (ROM) in day 1
Primary	change of ROM for shoulder flexion assessment in day 14	mobile applications (apps) specifically designed to measure ROM	Goniometer record apps was used to measure shoulder flexion range of movement (ROM) in day 14
Primary	change of ROM for shoulder flexion assessment in day 28	mobile applications (apps) specifically designed to measure ROM	Goniometer record apps was used to measure shoulder flexion range of movement (ROM) in day 28
Primary	status of shoulder pain assessment 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)	evaluate psychometric properties within the distinct targeted samples in day 1
Primary	change of shoulder pain assessment 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)	evaluate psychometric properties within the distinct targeted samples in day 14
Primary	change of shoulder pain assessment 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)	evaluate psychometric properties within the distinct targeted samples in day 28
Secondary	presentation of an individual's perception of their current health state	Quality-of-Life Scale from 0 to 10 (0 is the worst health you could imagine. 10 is the best health you could imagine)	questionnaire is used to asses the quality of patient's life at the first day of treatment
Secondary	change in presentation of an individual's perception of their current health state	Quality-of-Life Scale from 0 to 10 (0 is the worst health you could imagine. 10 is the best health you could imagine)	this questionnaire will be used to asses the quality of patient's life at the day 28 of treatment