Does an Audio-visual Aid Reduce Anxiety and Improve the Understanding of Children Undergoing an Alveolar Bone Graft: Randomised Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 56
- 试验地点
- 2
- 主要终点
- State Anxiety Section of State-Trait Anxiety Inventory for Children
研究概览
简要总结
Patients born with a cleft of the lip and/or palate may have a gap in the bone in the roof of their mouth and in the area of bone where the teeth develop. These patients require an alveolar bone graft (ABG) to allow the eruption of the maxillary canine teeth amongst other reasons. The optimal time to carry this out is between the ages of nine and eleven.
Whilst the patients will have had interventions as infants, this is often the first procedure a child born with a cleft lip and/or palate is likely to comprehend.
An audio-visual guide has been developed by the Great Ormond Street Hospital Dental Department for children undergoing an ABG. It explains the reason for the procedure, what the process will involve and advice regarding postoperative care.
This study will try ascertain whether providing information to patients and parents in this manner reduces anxiety, improves understanding of why the procedure was undertaken and post-operative care.
Children between the ages of eight and twelve ready for this procedure at Great Ormond Street Hospital will be enrolled. They will be allocated into two groups during their assessment appointment. The control will be given standardised verbal and written information, whilst the experimental group will also be given the animation. The level of anxiety and understanding of the procedure will be measured after the intervention/control information and once again when the patient attends for their pre-surgical assessment two to three months later.
This study aims to see whether the patient and parent anxiety is reduced and knowledge regarding the procedure is improved when utilising this of kind audio-visual guide for children. This will indicate whether it is worthwhile committing resources to the development of similar animations for other procedures.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 8 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •Diagnosed Syndrome
- •Identified global developmental delay
- •Previous alveolar bone graft
- •Patient and/or parent/guardian unable to read/understand English
- •Declined to participate
结局指标
主要结局
State Anxiety Section of State-Trait Anxiety Inventory for Children
时间窗: Change from baseline to surgical pre-assessment appointment, an average of 3months
Validated measure of Child State Anxiety
次要结局
- Parent/Legal Guardian Questionnaire(Change from baseline to surgical pre-assessment appointment, an average of 3months)
- State Anxiety section of State-Trait Anxiety Inventory(Change from baseline to surgical pre-assessment appointment, an average of 3months)
- Patient Questionnaire(Change from baseline to surgical pre-assessment appointment, an average of 3months)