Recruiting

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

Sponsor:

Queen's University

Code:

NCT02704442

Conditions

Anxiety

Strabismus

Compliance

Eligibility Criteria

Sex: All

Age: 3 - 10

Healthy Volunteers: Accepted

Study Details

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.

Conditions

Anxiety

Strabismus

Compliance

Study ID

NCT02704442

Start date

Feb, 2016

Status verified date

Apr, 2018

Completion date

Sep, 2019

Anticipated

Primary completion date

Sep, 2019

Anticipated

Eligibility Criteria

Sex: All

Age: 3 - 10

Healthy Volunteers: Accepted

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

Enrollment

82 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

Change in Compliance with Ophthalmology examination [ Time Frame: 4 days and 6 weeks after surgery ]

Central Contacts and Locations

Central contacts

Rachel Rooney, MD

613 549-6666 rooneyr@kgh.kari.net

Yi Ning Strube, MD

613 544-3310 strubey@hdh.kari.net

Locations

Hotel Dieu Hospital

Recruiting

Kingston, Ontario, Canada, K7L 5G2

Contacts

Rachel Phelan, MSc

613 549-6666 phelanr@KGH.KARI.NET

More Information

Sponsor

Queen's University

Last update posted

Apr 26, 2018

Last verified

Apr, 2018

Keywords

anesthesiology
ophthalmology

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Queen's University on 2018-04-26.