Immersive Versus Passive Virtual Reality on Upper Limb Pain and Range of Motion in Pediatric Burn

September 23, 2024 updated by: Haytham Mostafa, Cairo University
The purpose of the present study was to declare the difference between using immersive virtual reality vs passive virtual reality on pain management and improvement of ROM post physiotherapy exercise and mobilization sessions in pediatric burn patients.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Burn injuries are devastating and cause long-term damage to health. Thermal injuries, caused by hot liquids, solids, or fire, account for the majority of these injuries. Around 11 million burn cases occur annually worldwide. Rehabilitation aims to improve joint range od motion and control pain. Nonpharmocologic strategies like hypnosis and VR systems have shown promise in pain control. Multidisciplinary interventions from psychologists, physiotherapists, and pain management specialists can contribute to patient recovery. VR offers a holistic care device for pediatric burn patients.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt
        • Haytham Mostafa Youssef

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Sixty patients have 2nd degree thermal burn injury, from both genders their ages will be ranged from 7 - 17 years old.
  2. They will be diagnosed by their physicians with 2nd degree thermal burn injury affecting upper limbs and referred for physical therapy management .
  3. TBSA calculated up to 9 for one upper limb.
  4. The patients will be in the acute stage post burn injury; the duration of burn will be 3 weeks post injury.
  5. Medically and psychologically stable patients

Exclusion Criteria:

The potential participants will be excluded if they meet one of the following criteria:

  1. Cardiac diseases.
  2. Hand Burn
  3. Exposed tendons.
  4. Patients who suffer from skin diseases, diabetes, varicose veins, and peripheral vascular diseases.
  5. Patients with life threatening disorders as renal failure, myocardial infarction or other similar diseases.
  6. Patients with facial burn.
  7. Patients will have an inability to tolerate visual stimulation (e.g., susceptibility to migraines aggravated by light) or inability to tolerate the head mounted display (e.g., sensitivity to touch around the face and head).
  8. Patients with visual or auditory disorders.
  9. Patients with unstable fractures.
  10. Central Nervous System (CNS) problems.
  11. Patients with medical red flags as severe psychiatric disorder or cognitive deficits .
  12. Medically unstable and uncooperative patients.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Immersive virtual reality
consisted of 30 patients and received procedure as immersive virtual reality program selected to enhance patient to use his upper limbs in order to interact with the show or game selected
Device: Virtual reality games in immersive VR modality
virtual reality involved three characters: a muscular boxer, a superhero, and a rock climber, with patients performing tasks in standing or sitting. Each experience takes 6 minutes, with 5-minute intervals between. Experimenters will instruct users on hand controls and virtual body observation.
Other: traditional physiotherapy
Includes stretching exercise for upper limb muscles affected by burn, scar tissue release , and splinting technique.
Active Comparator: Passive virtual reality
consisted of 3o patients and received procedure as passive virtual reality program as the patient just wear the headset with a view or show meant only to distract pain while following therapist commands to do active or active assisted upper limbs ROM ex.
Other: traditional physiotherapy
Includes stretching exercise for upper limb muscles affected by burn, scar tissue release , and splinting technique.
Device: Virtual reality show in passive VR modality:
In this modality the patient was asked to have a comfortable seat wearing the head set without holding the controllers , the therapist will play a relaxing show as a nature view or colorful scene as a sort of relaxation and mind distraction for around 20 minutes while asking the patient to perform upper limb muscle ROM exercise in active or active assisted form.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
assessing the pain intensity using Colored Analog Scale (CAS)
Time Frame: at baseline and after 6 weeks
The Colored Analog Scale (CAS) is a thermometer-like tool that gradually darkens red as you progress, allowing children to indicate their pain levels with markers on the scale's back.
at baseline and after 6 weeks
assessing the range of motion using digital goniometer
Time Frame: at baseline and after 6 weeks
The physical therapist will have to measure ROM before and after the intervention to monitor the improvement ,as the study focus on upper limb range of motion , following joints movement will be measured : shoulder flexion and abduction , elbow flexion and extension , wrist flexion and extension , forearm supination and pronation)
at baseline and after 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 10, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 10, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 10, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 23, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 23, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 25, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 25, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 23, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Haitham-005156

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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