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Virtual Reality on Pain and Range of Motion on Burn

Primary Purpose

Burns

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
active assisted exercise and with fully immersive Head-Mounted Display virtual reality ( Oculus Quest virtual reality (VR) headset with hand con
active assisted range of motion exercise
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Burns focused on measuring burn injuries

Eligibility Criteria

9 Years - 16 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Ahmed Orabi hospital for burn and tumorsRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

active assisted exercise with Oculus Quest virtual reality (VR) group

active assisted range of motion exercise group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

status of ROM for shoulder flexion assessment in day 1
mobile applications (apps) specifically designed to measure ROM
change of ROM for shoulder flexion assessment in day 14
mobile applications (apps) specifically designed to measure ROM
change of ROM for shoulder flexion assessment in day 28
mobile applications (apps) specifically designed to measure ROM
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)
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)
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)

Secondary Outcome Measures

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)
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)

Full Information

First Posted
April 13, 2022
Last Updated
January 14, 2023
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT05352711
Brief Title
Virtual Reality on Pain and Range of Motion on Burn
Official Title
Effect of Virtual Reality Exercise on Pain and Range of Motion in Pediatrics With Second Degree Anterior Shoulder Burn Injuries
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 20, 2022 (Actual)
Primary Completion Date
May 30, 2023 (Anticipated)
Study Completion Date
June 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Burns
Keywords
burn injuries

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
active assisted exercise with Oculus Quest virtual reality (VR) group
Arm Type
Experimental
Arm Description
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.
Arm Title
active assisted range of motion exercise group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
active assisted exercise and with fully immersive Head-Mounted Display virtual reality ( Oculus Quest virtual reality (VR) headset with hand con
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
active assisted range of motion exercise
Intervention Description
Patients were treated active assisted ROM physical therapy 2 sessions per week for 4 weeks.
Primary Outcome Measure Information:
Title
status of ROM for shoulder flexion assessment in day 1
Description
mobile applications (apps) specifically designed to measure ROM
Time Frame
Goniometer record apps was used to measure shoulder flexion range of movement (ROM) in day 1
Title
change of ROM for shoulder flexion assessment in day 14
Description
mobile applications (apps) specifically designed to measure ROM
Time Frame
Goniometer record apps was used to measure shoulder flexion range of movement (ROM) in day 14
Title
change of ROM for shoulder flexion assessment in day 28
Description
mobile applications (apps) specifically designed to measure ROM
Time Frame
Goniometer record apps was used to measure shoulder flexion range of movement (ROM) in day 28
Title
status of shoulder pain assessment in day 1
Description
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)
Time Frame
evaluate psychometric properties within the distinct targeted samples in day 1
Title
change of shoulder pain assessment in day 14
Description
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)
Time Frame
evaluate psychometric properties within the distinct targeted samples in day 14
Title
change of shoulder pain assessment in day 28
Description
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)
Time Frame
evaluate psychometric properties within the distinct targeted samples in day 28
Secondary Outcome Measure Information:
Title
presentation of an individual's perception of their current health state
Description
Quality-of-Life Scale from 0 to 10 (0 is the worst health you could imagine. 10 is the best health you could imagine)
Time Frame
questionnaire is used to asses the quality of patient's life at the first day of treatment
Title
change in presentation of an individual's perception of their current health state
Description
Quality-of-Life Scale from 0 to 10 (0 is the worst health you could imagine. 10 is the best health you could imagine)
Time Frame
this questionnaire will be used to asses the quality of patient's life at the day 28 of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
9 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Heba Alaa Abd-Elhafez, Master
Phone
01001586797
Email
hebaalaa1988h@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amal Mohamed Abd Albaky, Professor
Organizational Affiliation
Vice dean of high education Faculty of Physical Therapy Cairo University
Official's Role
Study Chair
Facility Information:
Facility Name
Ahmed Orabi hospital for burn and tumors
City
Cairo
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
ahmed adel

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Virtual Reality on Pain and Range of Motion on Burn

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