Does Anxiety in Children on the Day of Surgery Impact Compliance in the Ophthalmology Clinic?

• Conditions: Anxiety; Strabismus; Compliance

• Registration Number: NCT02704442
• Lead Sponsor: Queen's University

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2016-02
• Study First Submitted: 2016-02-17
• Study First Submitted QC: 2016-03-04
• Study First Posted: 2016-03-10
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-24
• Last Update Posted: 2018-04-26
• Primary Completion: 2019-09
• Study Completion: 2019-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 82

Inclusion Criteria

• Age 3 - 10 years old
• ASA I - III
• Primary strabismus surgery one or both eyes

Exclusion Criteria

• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in Compliance with Ophthalmology examination	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)

Secondary Outcome Measures

Name	Time	Method
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	Levels of parental anxiety will be measured by completion of the State-Trait Anxiety Inventory-state version at 3 time-points stated.
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 observer-rated anxiety on day of surgery will be measured using the modified Yale Preoperative Anxiety Scale at 5 time-points throughout day-surgery process as described above and at Ophthalmology Clinic after surgery (i.e., day 4 post-surgery and 6 weeks post-surgery)
child temperament	pre operative assessment	Parents will also be asked to complete a measure of child temperament \[i.e., Emotionality, Activity, Sociability, Impulsivity temperament scale prior to the day of surgery (i.e., at clinic one week prior to surgery) 11.

Trial Locations

Locations (1)

Hotel Dieu Hospital; 🇨🇦 Kingston, Ontario, Canada