Does Anxiety in Children on the Day of Surgery Impact Compliance in the Ophthalmology Clinic?
试验速览
- 阶段
- 不适用
- 入组人数
- 82
- 试验地点
- 1
- 主要终点
- Change in Compliance with Ophthalmology examination
研究概览
简要总结
The hypothesis is that pediatric patients with increased levels of anxiety on the day of surgery, in particular at point of anesthetic induction, will demonstrate decreased compliance with assessment in ophthalmology clinic postoperatively.
详细描述
There are many studies demonstrating pediatric anxiety from a surgical experience leading to postoperative maladaptive behaviors such as nightmares, separation anxiety, eating problems, and increased fear of doctors. There is a significant amount of research looking at day of surgery anxiety and pain in children and possible modifiers. Very little work has explored the effect of maladaptive behaviors with follow up physician visits. Strabismus surgery is particularly important as children require early and regular follow up assessments after surgery for optimal outcome. These assessments are meticulous and require good patient cooperation in order to obtain useful information for the pediatric ophthalmologist.
The study hypothesis is that pediatric patients with increased levels of anxiety on the day of surgery, in particular at point of anesthetic induction, will demonstrate decreased compliance with assessment in ophthalmology clinic postoperatively. The investigators expect this decrease in compliance will be evident based on changes seen on the ophthalmology clinic compliance scores generated pre and postoperatively.
The proposed study will be a prospective cross sectional study. Investigators will be measuring compliance in the ophthalmology clinic pre and postoperative and relating any changes in compliance with anxiety levels on the day of surgery.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 3 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 3 - 10 years old
- •ASA I - III
- •Primary strabismus surgery one or both eyes
排除标准
- •Preexisting anxiety disorder
- •Preexisting chronic pain or chronic analgesia use
- •Neurobehavioural pathology limiting our ability to assess the patient eg: Cerebral Palsy, Autism or Developmental Delay.
- •Inability to adhere to study protocol
- •Consult in Anesthesiology clinic prior to surgery
结局指标
主要结局
Change in Compliance with Ophthalmology examination
时间窗: 4 days and 6 weeks after surgery
A five point observer-rated Ophthalmology Clinic Compliance Checklist (OCCC) will be completed at the clinic visit one week prior to surgery and then at the 4 day and 6 week postoperative visits. The checklist includes sitting the ophthalmic chair, cover test, vision testing, stereo acuity and cycloplegic refraction. Compliance will be rated on a scale of 0 (non compliant ) 1 (compliant with minor coaxing) 2 (compliant with heavy coaxing) 3 (easily compliant)
次要结局
- parent anxiety(measured at 4 time points: 1. at the last clinic visit prior to surgery (approximately 7 days), on day of surgery 2. at admission to hospital and 3. in the recovery room after surgery and 4. 4 days after surgery at the post op clinic visit)
- child observer rated anxiety(Observations on day of surgery at time points 1. admission to hospital 2. day surgery waiting area 3. just prior to entering the operating room 4. anesthetic induction 5. recovery room and at 4 days and 6 weeks post operatively)
- child temperament(pre operative assessment)
研究者
Dr. Rachel Rooney
Rachel Rooney MD FRCPC, Assistant Professor Department of Anesthesiology, Queen's University
Queen's University