Study Overview This is a single-centre prospective randomised control trial at (Great Ormond Street Hospital) with concealed allocation. A randomised controlled trial was chosen to allow equal distribution of confounding factors including age, gender and previous experience of orthodontic or surgical procedures.
Enrollment Patients identified by the cleft team as needing an alveolar bone graft are booked onto joint maxillofacial - orthodontic clinics which run several times a week. The clinical notes of these clinics will be screened for patients by a member of the study team (who are also part of the clinical care team) two weeks before a clinic The parents/guardian of patients identified as meeting the inclusion/exclusion criteria will be called by identified members of the research team to explain the study. They will seek consent for Patient Information Sheets (PIS) to be posted to their registered address at least one week before the appointment date (Appendix D\&E).
On the day of the assessment, children deemed suitable will be invited to participate. The researcher will go through the PIS verbally in detail allowing the participants to ask any questions. Verbal and then written consent will be obtained from those willing to participate. They will be allocated into a control or intervention group using a random number generator to ensure a randomised and concealed allocation process.
The sample size calculation has been carried out, using previous studies that have used the primary outcome measure. 56 children will be recruited accounting for a 20% drop out rate.
The Null Hypothesis:
The "ACE" animation does not reduce the anxiety of patients between the age of eight and twelve years undergoing an alveolar bone graft (ABG).
Alternative Hypothesis:
The "ACE" animation reduces the anxiety of patients between the age of eight and twelve years undergoing an alveolar bone graft (ABG).
Intervention A control group will receive standardised verbal and written information (the current protocol). The study group will additionally be given the "ACE" animation.
A control arm will be utilised, so the investigators can ascertain if the animation does make a difference to the anxiety and understanding of children/adults. As the animation is not routinely provided to children, this group will not be disadvantaged when compared to our current practice and patient cohort.
However, if the alternative hypothesis is true the control group will be disadvantaged. The investigators will mitigate this by showing all those in the control group the animation (during the pre-assessment appointment).
Outcome Measures The primary outcome measure is the State Anxiety Section of State-Trait Anxiety Inventory for Children (STAIC -S)- a validated measure of child anxiety (Appendix B). This will be given to both groups on enrolment (T1) as a baseline. At the end of the assessment appointment during which participants will have received the control or intervention they will be asked to fill this questionnaire again (T2). The patient will be asked to fill this anxiety assessment when they attend for their pre-surgical assessment which is usually 2-3months later (T3). This will allow us to ascertain whether there is a short and/or long-term change in anxiety.
The secondary outcome measures will be assessed by the State Anxiety section of State-Trait Anxiety Inventory (Appendix Bii), to be filled in by the parents at the same time points (T1,T2,T3).
In addition, participants and parents of both intervention and control will fill in their respective parts of a questionnaire that assesses their self-reported understanding of the procedure (Appendix Ci and Cii). This will happen at time points T2 (end of assessment appointment) and T3(end of pre-surgical appointment).
This questionnaire has been developed by an expert panel of Consultant Orthodontists, Restorative Dentists, Paediatric dentists, Maxillofacial and Oral Surgeons and Clinical Psychologists, followed by a Patient and Public Involvement session with the GOSH London Young Person's Advisory Group - a group of 8 to 21 year olds.
This group was invited to recommend changes to the Participant Information Sheets, Consent/Assent forms and Questionnaires to improve their acceptability and readability. They were also asked to make changes to the questionnaire to better reflect what they wanted to know as patients and the public. Changes to the layout and wording were presented to the Expert panel and broadly accepted. The YPAG voted this project as being the most interesting and informative of their session.
Bias in the study will be minimised by randomisation and concealed allocation processes. Patients/parents will be blinded, they will not be told if they are in the control or intervention group. The Participant Information Sheets do not mention an animation.
Statistical analysis This will be undertaken by a statistician independent from the clinical care team who is blinded to which group is the intervention and the control.
A narrative description of the protocol is given in Appendix N.
