Virtual Reality on Pain and Range of Motion on Burn

NCT ID: NCT05352711

Last Updated: 2024-02-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-20
• Study Completion Date: 2023-06-30

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.

Conditions

Burns

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

active assisted exercise and with fully immersive Head-Mounted Display virtual reality ( Oculus Quest virtual reality (VR) headset with hand con

Intervention Type: DEVICE

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 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.

Group Type: ACTIVE_COMPARATOR

active assisted range of motion exercise

Intervention Type: OTHER

Patients were treated active assisted ROM physical therapy 2 sessions per week for 4 weeks.

Interventions

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.

Intervention Type: DEVICE

active assisted range of motion exercise

Patients were treated active assisted ROM physical therapy 2 sessions per week for 4 weeks.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 9 Years
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Heba Alaa Eid Abd-Elhafez

lecturer assistant

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Amal Mohamed Abd Albaky, Professor

Role: STUDY_CHAIR

Vice dean of high education Faculty of Physical Therapy Cairo University

Locations

Ahmed Orabi hospital for burn and tumors

Cairo, , Egypt

Countries

Egypt

Other Identifiers

P.T.REC/012/003467

Identifier Type: -

Identifier Source: org_study_id