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.: PACTR202408890738522 Date of Approval: 15/08/2024
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Comparative evaluation of the effectiveness of virtual reality glasses and onscreen audio-visual distraction in reducing dental anxiety among 6 to 12 years old dental patients in Lagos university teaching hospital
Official scientific title Comparative evaluation of the effectiveness of virtual reality glasses and onscreen audio-visual distraction method in reducing dental anxiety among 6 to 12 years old dental patients in Lagos university teaching hospital
Brief summary describing the background and objectives of the trial Children are usually anxious during dental treatment. Therefore, behaviour management is important in order to achieve cooperation of these children and to perform treatment effectively. This study aims at comparing the effectiveness of virtual reality distraction and on-screen audio-visual distraction technique in reducing anxiety during local anaesthesia administration in paediatric dental patient. OBJECTIVES 1. To assess level of anxiety measured by pulse rate, oxygen saturation, facial image scale and Frankle behaviour rating scale during local anaesthesia administration among 6 to 12 years old paediatric dental patients using onscreen audio-visual distraction technique in Lagos University Teaching Hospital. 2. To assess level of anxiety measured by pulse rate, oxygen saturation, facial image scale and Frankle behaviour rating scale during local anaesthesia administration among 6 to 12 years old paediatric dental patients using virtual reality distraction technique in Lagos University Teaching Hospital. 3. To compare the level of anxiety measured by pulse rate, oxygen saturation, facial image scale and Frankle behaviour rating scale during local anaesthesia administration among 6 to 12 years old paediatric dental patients while using onscreen audio-visual distraction and while on virtual reality distraction technique in Lagos University Teaching Hospital. 4. To compare the level of anxiety between males and females measured by pulse rate, oxygen saturation, facial image scale and Frankle behaviour rating scale during local anaesthesia administration among 6 to 12 years old paediatric dental patients while using onscreen audio-visual distraction technique in Lagos University Teaching Hospital. 5. To compare the level of anxiety between males and females measured by pulse rate, oxygen saturation, facial image scale and Frankle behaviour rating scale during local anaesthesia administration among 6 to 12 years old paediatric dental patients while using virtual r
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 Psychosocial
Anticipated trial start date 02/08/2024
Actual trial start date 02/08/2024
Anticipated date of last follow up 30/01/2025
Actual Last follow-up date 30/01/2025
Anticipated target sample size (number of participants) 52
Actual target sample size (number of participants) 52
Recruitment status Active, not recruiting
Publication URL not yet
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 by using procedures such as coin-tossing or dice-rolling Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Virtual reality behaviour management technique Virtual reality distraction will be watched by the participants throughout the treatment period, only on the first visit. About 30minutes to 1 hour VIRTUAL REALITY GROUP VR SHINECON SC-G04 which uses a phone application which converts any multimedia content into virtual reality and gives a cinematic experience will be used. The device has an elastic band which fits to different sizes of head circumference. It gives a 100degree field of view, and also gives a 3D effect, immersing the child into the virtual world. Child will be asked to choose a video from a list of popular cartoon shows. The list of popular cartoons will be determined by asking the children that come to the paediatric dental clinic prior to the study. The chosen cartoon will be played on the smartphone and it will be converted to virtual reality by an application (Home Theatre VR) and the phone will be inserted into the VR SHINECON and it will then be mounted on the child’s head. 26
Control Group Onscreen audiovisual distraction technique Throughout the treatment period, only on the first dental visit. 30minutes to 1hour ONSCREEN AUDIOVISUAL DISTRACTION GROUP The child will be asked to choose a video from a list of popular cartoon shows. The list of popular cartoons will be determined by asking the children that come to the paediatric dental clinic prior to the study. The chosen cartoon will be played from the screen attached to the dental chair. 26 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Inclusion Criteria • Children aged 6 years to 12years. • Children without any underlying medical condition. • Children with no history of local anaesthesia administration • Children with positive (Frankle 2) and negative(Frankle3) categories based on Frankle behaviour rating scale. • Children who require administration of local anaesthesia (inferior alveolar nerve block) for pulp therapy or tooth extraction. • Children whose parent or guardian have given consent. • Children who have given assent (7years to 12years) Exclusion criteria • Children undergoing extraction due to orthodontic reasons or due to retained teeth • Children with underlying medical conditions (epilepsy, migraine and ear disturbance) • Children with history of eventful medical experience like surgeries, hospital admissions and trauma. • Children with special needs (cerebral palsy, down syndrome) • Patients who require conscious sedation or general anaesthesia Child: 6 Year-12 Year 6 Year(s) 12 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 20/02/2024 Lagos university teaching hospital health research ethics committee
Ethics Committee Address
Street address City Postal code Country
Idi-Araba, Lagos Lagos 100254 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome OBJECTIVE ASSESSMENT USING THE PHYSIOLOGICAL ASSESSMENT The level of anxiety will be assessed objectively by using pulse rate and oxygen saturation with fingertip oximeter PC-60FW which will be attached to the thumb. Before the onset of treatment, during dental treatment, precisely during local anaesthesia administration and after local anaesthesia administration.
Secondary Outcome SUBJECTIVE ASSESSMENT USING THE SELF-REPORT ASSESSMENT The level of anxiety will be assessed subjectively by using facial image scale which which is a paper containing 5 cartoon faces expressing the feelings of the child ranging from very happy to very sad. children will be expexted to choose the face that best describe their feeling during the treatment. Frankle behaviour rating scale, child’s behaviour is being classified into four groups according to the child’s attitude and cooperation or lack of cooperation during dental treatment. It consists of four behaviour categories ranging from definitely negative to definitely positive, which are assigned by the treating clinician and can be applied at various stages during treatment Before the onset of dental treatment, during dental treatment, precisely during local anaesthesia administration and after local anaesthesia administration.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Lagos university teaching hospital Lagos university teaching hospital. Idi-Arabi, Lagos. Lagos 100254 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Tabitha Jauro Idi-Araba Lagos 100254 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Tabitha Jauro. Self sponsored. Id-Araba Lagos 100254 Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Tabitha Jauro tabithajauro44@gmail.com +2348064363018 Department of child dental health, Lagos university teaching hospital. Idi-Araba. Lagos
City Postal code Country Position/Affiliation
Lagos 100254 Nigeria Self
Role Name Email Phone Street address
Public Enquiries Tabitha Jauro tabithajauro44@gmail.com +2348064363018 Department of child dental health, Lagos university teaching hospital. Idi-Araba. Lagos
City Postal code Country Position/Affiliation
Lagos 100254 Nigeria Self
Role Name Email Phone Street address
Scientific Enquiries Tabitha Jauro tabithajauro44@gmal.com +2348064363018 Department of child dental health, Lagos university teaching hospital. Idi-Araba. Lagos
City Postal code Country Position/Affiliation
Lagos 100254 Nigeria self
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes I assure that all individual participant data (raw data) that will be collected for this study, after de-identification, not just the summarized result, will be shared to other researchers and organizations. Informed Consent Form Within 12 months of completion of the study. Before December, 2026. No end date. Any researcher or organization who wishes to have access to the data
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Not available yet. 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