Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201911758375635 Date of Approval: 15/11/2019
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Virtual Reality as Pain Distraction during Physical Rehabilitation in Pediatric Burn
Official scientific title Virtual Reality as Pain Distraction during Physical Rehabilitation in Pediatric Burn
Brief summary describing the background and objectives of the trial VR is a promising and engaging intervention that may help to decrease pain and anxiety for children undergoing painful procedures and suffering from acute pain. Thus, the purpose of this study is to determine the impact of VR on pain and ROM of children with burn injuries during post-burn rehabilitation therapy treatment sessions.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Paediatrics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 02/12/2018
Actual trial start date 30/12/2018
Anticipated date of last follow up 30/05/2019
Actual Last follow-up date 30/06/2019
Anticipated target sample size (number of participants) 22
Actual target sample size (number of participants) 22
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group virtual reality training physical therapy session lasted for 20 minutes consisting of active-assisted range-of-motion and stretching exercises for both the upper and the lower extremities. The subjects in the study group was treated by the same exercises program for 20 minutes while using virtual reality oculus as a distraction method and the subjects in the study group was allowed to choose the favorite video. 2o minutes exercise Each subject received standard pre-procedure pharmacologic analgesia/sedation, This regimen was administered at the discretion of the subject’s physicians was independent of the study protocol. Each physical therapy session lasted for 20 minutes consisting of active-assisted range-of-motion and stretching exercises for both the upper and the lower extremities which guided by the same therapist. During the physical therapy session, subjects participated in therapist-directed, slow stretching of the selected extremity to the end range of the joint in all planes of movement. If a second joint was also manipulated, the proximal joint was manipulated first, followed by the distal joint. The subjects in the study group were treated by the same exercises program for 20 minutes while using virtual reality oculus as a distraction method and the subjects in the study group were allowed to choose the favorite video. 11
Control Group Control group exercise session only without virtual reality 20 minutes Each subject received standard pre-procedure pharmacologic analgesia/sedation, This regimen was administered at the discretion of the subject’s physicians was independent of the study protocol. Each physical therapy session lasted for 20 minutes consisting of active-assisted range-of-motion and stretching exercises for both the upper and the lower extremities which guided by the same therapist. During the physical therapy session, subjects participated in therapist-directed, slow stretching of the selected extremity to the end range of the joint in all planes of movement. If a second joint was also manipulated, the proximal joint was manipulated first, followed by the distal joint. 11 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
both sex and age ranged from 9 to 16 years old 2nd degree deep partial thickness burn of TBSA (15%-25%) significant facial, ear or scalp injuries that prevented them from wearing a VR oculus, suffered from a seizure disorder, had full-joint ROM Adolescent: 13 Year-18 Year,Child: 6 Year-12 Year 9 Year(s) 16 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 10/11/2019 Batterjee Medical college
Ethics Committee Address
Street address City Postal code Country
Prince Abdullah Al-Faisal Street Jeddah 21424 Saudi Arabia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome pain intensity before and after session
Secondary Outcome Range of motion ROM before and after session
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Om Elmasreen Hospital salah salem street . Giza Giza Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Ali Selim Salah salem Giza 12652 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Dr. Ali Osman salah salem street. Giza 12652 Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
Dr. Mohamed A.Abd El Ghafar Prince Abdullah Al-Faisal Street Jeddah Saudi Arabia
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ali Selim pt10.jed@bmc.edu.sa +201003695354 salah salem
City Postal code Country Position/Affiliation
Giza 12652 Egypt Assistant professor
Role Name Email Phone Street address
Public Enquiries Mohamed A. Abd El Ghafar pt12.jed@bmc.edu.sa +966531513909 Prince Abdullah Al-Faisal Street
City Postal code Country Position/Affiliation
Jeddah 6231 Saudi Arabia Assistant professor
Role Name Email Phone Street address
Scientific Enquiries Osama Raga pt4.jed@bmc.edu.sa +201116471299 Prince Abdullah Al-Faisal Street
City Postal code Country Position/Affiliation
jeddah Saudi Arabia Assistant professor
Role Name Email Phone Street address
Scientific Enquiries Olfat Ali olfat_ib@yahoo.com +021001248426 7 Ahmed alzayat
City Postal code Country Position/Affiliation
Giza 12611 Egypt Assistant professor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes results will be shared as we finish publication there was a significant difference between study and control groups in pain and range of motion favoring study group which received virtual reality Informed Consent Form,Study Protocol As we finish the publication process results will be available as we published the article
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information