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.: PACTR201602001461690 Date of Approval: 06/02/2016
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Virtual Reality Glasses Distraction versus Oral Midazolam as Premedication on Children Behavior for Outpatient Pediatric Dental Surgery
Official scientific title A Comparative Evaluation of Virtual Reality Glasses Distraction and Oral Midazolam as Premedication on Children Behavior for Outpatient Pediatric Dental Surgery
Brief summary describing the background and objectives of the trial The main objectives of premedication in children are to facilitate the separation from the parents, to reduce preoperative anxiety, to smooth the induction of anesthesia and to lower the risk of postoperative behavioral disorders. The most common technique is sedative premedication with midazolam. The aim of the present study will be to evaluate the efficacy of Virtual Reality Glasses showing 3D cartoon on anxiety and preoperative behavioral disorders versus midazolam.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied ,Paediatrics,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Devices
Anticipated trial start date 01/02/2016
Actual trial start date 15/02/2016
Anticipated date of last follow up 01/02/2017
Actual Last follow-up date 01/02/2017
Anticipated target sample size (number of participants) 90
Actual target sample size (number of participants) 90
Recruitment status Recruiting
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 Permuted block randomisation (block size was variable minimum of 4) Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Virtual Reality Glasses   audiovisual distraction 20 min before surgery Presenting 3D cartoon with earphone 45
Control Group oral Midazolam 0.5 mg/kg (diluted in a half glass of apple juice) 30 min before surgery. premedication 45 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
- ASA physical status I or II according to American society of Anesthesiologists. - Uncooperative behavior According to the Frankle Scale rating ONE (Definitely negative). - children had no previous exposure to General anesthesia. - Written consent from the child¿s parent(s) or legal guardian(s). ASA physical status III or IV according to American society of Anesthesiologists. Children with any mental, visual or auditory impairment. 3 Year(s) 6 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
No 15/02/2016 IRB, Faculty of Dentistry, University of Alexandria
Ethics Committee Address
Street address City Postal code Country
El Azerita Square Alexandria 21516 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Secondary Outcome Postopertive behavior of the child Postoperative behavioral disorders will be evaluated using the Post hospitalization Behavioral Questionnaire (PHBQ) at days 1 and 14 .
Primary Outcome Child anxiety from parents separaion Preoperative anxiety will be evaluated using using Parental Separation Anxiety Scale (PSAS) Heart rate will be obtained in the holding area (H1) and after separation (H2) .
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Alexandria Dental Research Center Smouha Alexandria 21516 Egypt
Department of Pediatric Dental General Anesthesia, Faculty of Dentistry, University of Alexandria. El Azerita Square Alexandria Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Faculty of Dentistry, University of Alexandria El Azerita Square Alexandria 21516 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of Dentistry, University of Alexandria El Azerita Square Alexandria 21516 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Karin Dowidar El Azerita Square Alexandria 21516 Egypt
Amal Mahmoud El Azerita Square Alexandria 21516 Egypt
Ola M Zanaty El Azerita Square Alexandria 21516 Egypt
Raghda Rizk 15 Garden City Smouha Alexandria 21516 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Karin Dowidar karindowidar55@gmail.com 00201222154965 El Azerita Square
City Postal code Country Position/Affiliation
Alexandria 21516 Egypt Professor of Pediatric Dentistry, Faculty of Dentistry, University of Alexandria
Role Name Email Phone Street address
Public Enquiries Elsayedamr Basma elsayedamr@yahoo.com 00201223106023 30 Garden City Smouha
City Postal code Country Position/Affiliation
Alexandria 21516 Egypt Patient Information Manager
Role Name Email Phone Street address
Scientific Enquiries Raghda Rizk raghdarizk@yahoo.com 00201224026365 15 Garden City Smouha
City Postal code Country Position/Affiliation
Alexandria 21516 Egypt Pediatric dentist
REPORTING
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Changes to trial information