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Clinical Trials/NCT02704442
NCT02704442
Unknown
Not Applicable

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

Queen's University1 site in 1 country82 target enrollmentFebruary 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Anxiety
Sponsor
Queen's University
Enrollment
82
Locations
1
Primary Endpoint
Change in Compliance with Ophthalmology examination
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 2016
End Date
September 2019
Last Updated
8 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Dr. Rachel Rooney

Rachel Rooney MD FRCPC, Assistant Professor Department of Anesthesiology, Queen's University

Queen's University

Eligibility Criteria

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

Outcomes

Primary Outcomes

Change in Compliance with Ophthalmology examination

Time Frame: 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 Outcomes

  • 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)

Study Sites (1)

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