Exploring Interventions for Children With Chronic Otitis Media With Effusion ('Glue Ear') When Services Are Reduced During Covid-19
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- acceptability of management strategy, questionnaire
研究概览
简要总结
During the Coronavirus pandemic children's hearing services are closed or reduced and grommet operations are part of the lowest priority group. In the absence of management options, this research study aims to see if bone conduction headphones either paired (via bluetooth) to a microphone or an app will help children with a hearing loss during this period of waiting. The child's quality of life is measured with validated questionnaires The study is over 3 months, and delivered remotely, with the product being sent to the family home and support offered via telephone/ video consulattion.
详细描述
Hypothesis
Transmission of speech aided by a wireless bone-conduction headphone connected to a wireless Bluetooth microphone during the prolonged waiting time (during the coronavirus pandemic) for the insertion of grommets, as well as access to the Hear Glue Ear software application is an acceptable management strategy during the coronavirus period where other forms of treatment and support are not available or indefinitely delayed. Questionnaires intend to capture data regarding families perception of child quality of life and developmental outcomes with this intervention.
Aim To quantify the differences in speech, language, and quality of life outcome measures between a group of children aided with a bone-conduction headphone and Hearing Glue Ear app during the coronavirus pandemic where usual care has been delayed such as waiting for grommet insertion.
Participants A total of 20 children will be enrolled in the study. If drop outs occur, new participants will be invited to replace those who withdrew from the study.
Participant recruitment Children known to Cambridge Audiology Services and known to have a diagnosis of glue ear will be invited to take part in the study if they satisfy the inclusion criteria. Consent will be obtained from their parents and an age appropriate explanation given to the child with the chance for the child to sign an age- appropriate assent form.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
It is too difficult to blind the assessor in thsi instance.
入排标准
- 年龄范围
- 3 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 3-11y
- •English used as a main language (since app is only written in English)
- •Glue ear with a hearing loss affecting at least 2 frequencies in at least one ear
排除标准
- •age range outside the 3-11 y parameter
- •normal hearing
- •not using english as a main language
结局指标
主要结局
acceptability of management strategy, questionnaire
时间窗: Acceptability will be measured on a Likert scale pre-assessment and the end of 3 months of using the intervention
questionnaire based accpetability question. A higher acceptability score will be positive for the intervention.
次要结局
- quality of life questionnaire OMQ-14(Questionnaires at beginning of study (as a baseline assessment and after 3 months of using the intervention. The sc)
研究者
Dr. Tamsin Brown
Paediatrician and chief investigator
Cambridgeshire Community Services NHS Trust