Modification of video-game prototype used in phase-I RCT
In preparation for the phase-II RCT, a few modifications of the prototype video game used in the phase-I RCT were necessary. The aim was to update the game in light of the results of the phase-I RCT, newly available technology, dietary guidelines, and the population to be targeted in the phase-II RCT.
The research team updated the game content, including the addition of a segment that includes advice on the consumption of fruit juice and another that includes advice on fluoride, as previous findings by the authors have suggested that this cohort of children and their parents received little advice on those two issues [11]. In addition, the game’s graphics were updated, including the introduction of a new avatar (Fluffy the hamster). CrazyTalk7 was used to develop the new avatar, and a new voiceover was recorded and used. Fig. 1 is an example of these updates. Finally, the game’s software was updated to HTML5 (software automatically installed on every computer, Smartphone or tablet) and the game was installed on a tablet (iPad), because they are more popular amongst children [27], can make the gaming experience easier and more interesting [28], and allow for easier set-up in the research location.
Once these modifications were introduced, the researcher (AA) ran the game numerous times to ensure it ran smoothly without any technical difficulties. The game was then further tested by a user group within the pilot study.
Pilot study
The pilot study aimed to: (i) assess user group interaction with the updated video game and notice any technical difficulties, (ii) assess feasibility of the main study protocol; (iii) assess blinding and randomization methods; and (iv) familiarize all members of the research team with the standard operating procedure.
The pilot study followed the same design, recruitment criteria and methods as the planned phase-II RCT. However, the introduction of blinding and randomization was gradual, so that the research team could be familiarized with the process. Data collection took place in May and June 2013.
Ten participants were recruited. Technical difficulties faced by the users during playing the video game were noted and corrected by the researcher (AA). In addition, the optimum physical setting for the study was determined and the team responsible for the day-to-day operations of the RCT (researcher (AA) and two trained dental nurses, both of whom had a health promotion qualification) became familiar with the recruitment, randomization and blinding processes.
Phase-II randomized controlled trial protocol
Methods and design
This study will be a two-armed blind RCT that will recruit children referred for dental extractions under general anaesthesia, as well as their parents. The participants will be randomized into two groups. In the study group, the child and escort will undergo self-directed ‘play’ about oral health using the video game on an iPad and receive a copy on a DVD to run it on a home personal computer. In the control group, the child and escort will receive verbal oral health advice from a dental nurse who has a health promotion qualification.
The participants will be recruited at the medical pre-assessment clinic at the day surgery unit at King’s College Hospital in London. All children scheduled for a procedure under general anaesthesia attend this clinic approximately two weeks prior to their surgery for a medical evaluation of fitness to undergo general anaesthesia.
Ethical considerations
Ethical approval was granted by the National Research Ethics Service Committee London, Dulwich (Reference number: 11/LO/0220), and by the Research and Development Department at King’s College Hospital (R&D Reference number: KCH12-013). Funding was provided through King’s College London PhD funds. Informed consent will be sought from each participating parent or guardian and assent will be sought from the children themselves. Participants will be able to withdraw from the trial at any time and this will not affect access to their treatment at the hospital.
All information disclosed in the study will be kept confidential and participants will not be identifiable in any material published as part of the study in any way. All data are stored without any identifying details. At all stages of research, the data will be stored using a password-protected computer and a secure locked cabinet; and all correspondence between research team members will be conducted using secure email.
Participants
The target population will be children referred for extraction of decayed teeth under general anaesthesia. Families will be invited to take part in the study at their child’s attendance at the medical pre-assessment clinic prior to their general anaesthesia appointment.
The inclusion criteria are as follows: the child is four to ten years old, does not have any learning difficulties or medical conditions complicating oral health status and is scheduled for treatment of dental caries under general anaesthesia. A parent or guardian should provide consent and both parent and child should have English proficiency.
The exclusion criteria are as follows: the child is referred for treatment of other dental conditions under general anaesthesia, has learning difficulties or a medical condition affecting oral health, is accompanied by an adult that cannot give consent, or, has been participating in another study. Families where either the parent or guardian or the child do not have sufficient English proficiency to consent or understand the advice delivered will also be excluded.
Sample size
The primary outcome measure in this study is user satisfaction with the intervention, assessed using a visual analogue scale. This is constructed as a continuous 100 mm line, with a score at the 0 mm mark indicating complete dissatisfaction with the intervention and a score at the 100 mm indicating complete satisfaction. As far as we know, this is the first study measuring patient’s satisfaction with the use of video games for oral health education. Assuming that our population will have a standard deviation of 25 mm, which is similar to patient satisfaction measured in studies in other fields [29], and aiming to detect a difference of at least 15 mm between the groups to indicate its clinical significance, a sample of 45 participants in each group will be needed to provide 80 % power, at the 5 % significance level, to detect effects of size 0.6 and above. This number of participants is also sufficient based on our calculations using the results of the pictorial dietary quiz used in the phase-I RCT. Anticipating a 20 % dropout rate [30], we intend to recruit approximately 108 participants.
Randomization and blinding
A computer-generated simple randomization grid will allocate the participants to the two groups. The randomization process will be overseen by the unblinded researcher (MTH). The allocation of participants will be performed by the two trained dental nurses responsible for applying the interventions to the participants. The researcher (AA) will remain blinded all through data collection and input. The statistician will also be blinded during the analysis. Only after data collection is complete will one researcher (MTH) break the randomization code to input the group allocation within the pre-existing data set and enable between-group analyses. The statistician and lead researcher (AA) will remain blinded.
Procedure for recruitment and application of intervention
Each week, the blind researcher (AA) will obtain a list of all children attending the medical pre-assessment clinic for general anaesthesia for dental purposes. Those who are younger than four or older than ten will be excluded.
Next, AA will go through the clinical notes of the remaining children to determine their eligibility to participate. At this stage, children who are having treatment for dental conditions other than caries, or with medical conditions affecting dental health or learning difficulties, and those children participating in other studies can be identified and excluded. All children accompanied by parents or guardians that require an interpreter to provide consent for the general anaesthesia procedure will also be excluded. However, the total number of those children will be recorded. The research will also record the different languages of the non-English speakers. South London is a culturally and ethnically diverse area, and keeping records of the languages spoken by those children and their families will help assess the local area’s future need for versions of the video game in different languages.
On the day of the clinic, AA will approach all potential participants, invite them to take part, and explain the study to them. At this stage, children accompanied by adults who cannot provide consent for them (aunt or uncle, older sibling, etc.) and those who do not display enough English proficiency to take part will also be excluded. AA will aim to approach every potential participant matching the inclusion criteria; however, some potential participants will be missed, as they will arrive and leave their appointment while a participant is taking part in the study.
Parents who indicate their agreement to take part will be asked to provide written consent and their child will be asked for assent. AA will then administer three following baseline measures. A pictorial dietary quiz will be completed by the child. This is the same quiz used in the phase-I pilot. (ii) A children’s dietary questionnaire will be completed by the parent. This is a validated measure used to report the dietary habits of children aged 4–16 years [31]. It includes four sections (covering intake of fruit and vegetables, dairy, sweet drinks, and non-core foods). Finally, details of the child’s most recent snack at school will be provided by the child.
After the baseline measures are completed, AA will introduce the participants to the dental nurse and leave, to ensure that he remains blinded to group allocation. The nurse will then allocate the participants to either the video-game group or the control group according to the randomization grid and will apply the intervention accordingly.
The nurse will administer postintervention measures to both groups including: (i) pictorial dietary quiz, completed by the child; (ii) child’s and parent’s satisfaction with intervention on a visual analogue scale; (iii) a booklet that contains a toothbrushing diary and a snack diary, to be returned on the day of the general anaesthesia procedure. The booklet given to children from the study group will also contain a page in which they can write five ‘secret words’ that have been inserted in the DVD version of the game. This will allow us to determine whether participants used the game DVD at home. Children from the control group will have a simple colouring page instead. Finally, (iv) the nurse will ask the parent and child if they have any feedback on the intervention; this feedback will be written down verbatim (qualitative data).
AA will go to the day surgery unit on the day of the child’s general anaesthesia procedure to collect the booklet. He will also call the participating parents three months after their child’s general anaesthesia procedure and offer them a review appointment at the paediatric dentistry department. Upon attending, the parents of both groups will be asked to complete the children’s dietary questionnaire again, to measure any changes in dietary practices at home. The child will be asked to retake the pictorial dietary quiz to assess long-term retention of dietary knowledge. Attendance rates from both groups will be noted.
Fig. 2 is a summary of the recruitment process and the measures collected.
Outcome measures
Fig. 3 outlines the various measures completed in the phase-II RCT. The primary outcome measures are:
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1.
Parent and child satisfaction with the intervention, as indicated using the visual analogue scale.
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Improvement in the child’s dietary knowledge measured by the change in pictorial dietary quiz score taken at baseline, postintervention, and after 3 months.
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3.
Change in child’s diet at home, measured by children’s dietary questionnaire taken at baseline and after 3 months.
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Return of the child’s toothbrushing diary showing their level of engagement in toothbrushing, and return of snack diary showing reported healthy snack selection.
The secondary outcome measures are:
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Parent and child verbal feedback on intervention in the form of qualitative data.
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Completion of ‘secret words’ sheet by children in intervention group, indicating use of game DVD at home.
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Attendance rates for review appointment after three months.
Statistical analysis
Descriptive statistics for all explanatory variables at baseline will be provided, overall and by study group. Analysis of variance and chi-square tests will be used to highlight any significant imbalance between groups.
Student’s t test will be used to compare the two groups’ parent and child visual analogue scale scores, indicating satisfaction with intervention. It will also be used to compare children’s dietary questionnaire, toothbrushing scores, and healthy snack selection scores. Since the children’s pictorial dietary quiz is the only measure taken at three points (baseline, directly after intervention, and three months later), its scores will be analysed using linear multivariate regression.
Verbal feedback provided by parents and children on intervention will be written down verbatim and will be analysed using simple content analysis.