Virtual Reality on Pain and Range of Motion on Burn

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

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.

Study Overview

• Status: Completed
• Conditions: Burns
• Intervention / Treatment: 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

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Ahmed Orabi hospital for burn and tumors

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 9 years to 16 years (Child)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: active assisted exercise with Oculus Quest virtual reality (VR) group; 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.	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.
Active Comparator: active assisted range of motion exercise group; 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.	Other: active assisted range of motion exercise; Patients were treated active assisted ROM physical therapy 2 sessions per week for 4 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Study Chair: Amal Mohamed Abd Albaky, Professor, Vice dean of high education Faculty of Physical Therapy Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): April 20, 2022
• Primary Completion (Actual): May 30, 2023
• Study Completion (Actual): June 30, 2023

Study Registration Dates

• First Submitted: April 13, 2022
• First Submitted That Met QC Criteria: April 26, 2022
• First Posted (Actual): April 29, 2022

Study Record Updates

• Last Update Posted (Actual): February 7, 2024
• Last Update Submitted That Met QC Criteria: February 6, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: burn injuries
• Additional Relevant MeSH Terms: Wounds and Injuries; Burns
• Other Study ID Numbers: P.T.REC/012/003467

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No