Providing information to children before alveolar bone grafts
Does an Audio-visual Aid Reduce Anxiety and Improve the Understanding of Children Undergoing an Alveolar Bone Graft: Randomised Control Trial
This study tests whether an audio-visual guide can help kids aged eight to twelve feel less anxious and understand their alveolar bone graft surgery better compared to just getting standard information.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 56 (estimated) |
| Ages | 8 Years to 12 Years |
| Sex | All |
| Sponsor | Great Ormond Street Hospital for Children NHS Foundation Trust Academic / other |
| Locations | 1 site (London) |
| Trial ID | NCT04381078 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of an audio-visual guide designed for children undergoing alveolar bone grafts due to cleft lip and palate. Conducted at Great Ormond Street Hospital, it aims to reduce anxiety and improve understanding of the procedure and postoperative care among patients and their parents. Participants aged eight to twelve will be randomly assigned to either receive the guide or standard information. The study will assess the impact of this intervention on patient anxiety and comprehension.
Who should consider this trial
Good fit: Ideal candidates are children aged eight to twelve with cleft lip and/or palate who require an alveolar bone graft.
Not a fit: Patients with diagnosed syndromes, global developmental delays, or those who have previously undergone an alveolar bone graft may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce anxiety in children undergoing alveolar bone grafts and enhance their understanding of the procedure.
How similar studies have performed: Previous studies have shown that providing structured information can improve patient outcomes, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients between the age of eight and twelve * With Cleft lip and/or palate requiring and ready for an alveolar bone graft * That consent to inclusion in the study * Irrespective of gender. Exclusion Criteria: * Diagnosed Syndrome * Identified global developmental delay * Previous alveolar bone graft * Patient and/or parent/guardian unable to read/understand English * Declined to participate
Where this trial is running
London
- Great Ormond Street Hospital — London, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Norman Hay, BDS FDS RCS
- Email: norman.hay@gosh.nhs.uk
- Phone: 020 7405 9200
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.