Clinical trial NCT02704442: Does Anxiety in Children on the Day of Surgery Impact Compliance in the Ophthalmology Clinic?
Official title: Does Anxiety in Children on the Day of Surgery Impact Compliance in the Ophthalmology Clinic?
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Anxiety
Strabismus
Compliance
Keywords: anesthesiology
ophthalmology
Lead sponsor: Queen's University
Sponsor class: OTHER
Collaborators: name: University of Regina
First posted: 2016-03-10
Enrollment: 82
Sex: ALL
Minimum age (years): 3
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study personnel with approach all pediatric patients who are American Society of Anesthesia (ASA) classification I to III, between the ages of 3 and 10 attending the ophthalmology clinic for primary strabismus repair

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.

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

Primary outcomes:
measure: Change in Compliance with Ophthalmology examination
timeFrame: 4 days and 6 weeks after surgery
Secondary outcomes:
measure: child observer rated anxiety
timeFrame: 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
measure: parent anxiety
timeFrame: 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
measure: child temperament
timeFrame: pre operative assessment
Other outcomes:
Locations:
city: Kingston
country: Canada
facility: Hotel Dieu Hospital
state: Ontario
Study officials:
affiliation: Queen's University
name: Rachel Rooney, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kain ZN, Caldwell-Andrews AA. Preoperative psychological preparation of the child for surgery: an update. Anesthesiol Clin North Am. 2005 Dec;23(4):597-614, vii. doi: 10.1016/j.atc.2005.07.003.
citation: Kain ZN, Mayes LC, Caldwell-Andrews AA, Karas DE, McClain BC. Preoperative anxiety, postoperative pain, and behavioral recovery in young children undergoing surgery. Pediatrics. 2006 Aug;118(2):651-8. doi: 10.1542/peds.2005-2920.
citation: Kain ZN, Wang SM, Mayes LC, Caramico LA, Hofstadter MB. Distress during the induction of anesthesia and postoperative behavioral outcomes. Anesth Analg. 1999 May;88(5):1042-7. doi: 10.1097/00000539-199905000-00013.
citation: Varughese AM, Nick TG, Gunter J, Wang Y, Kurth CD. Factors predictive of poor behavioral compliance during inhaled induction in children. Anesth Analg. 2008 Aug;107(2):413-21. doi: 10.1213/ane.0b013e31817e616b.
citation: Kain ZN, Mayes LC, Wang SM, Caramico LA, Hofstadter MB. Parental presence during induction of anesthesia versus sedative premedication: which intervention is more effective? Anesthesiology. 1998 Nov;89(5):1147-56; discussion 9A-10A. doi: 10.1097/00000542-199811000-00015.
citation: Wollin SR, Plummer JL, Owen H, Hawkins RM, Materazzo F. Predictors of preoperative anxiety in children. Anaesth Intensive Care. 2003 Feb;31(1):69-74. doi: 10.1177/0310057X0303100114.
citation: Wright KD, Stewart SH, Finley GA. When are parents helpful? A randomized clinical trial of the efficacy of parental presence for pediatric anesthesia. Can J Anaesth. 2010 Aug;57(8):751-8. doi: 10.1007/s12630-010-9333-1. Epub 2010 May 25.
citation: Kim JE, Jo BY, Oh HM, Choi HS, Lee Y. High anxiety, young age and long waits increase the need for preoperative sedatives in children. J Int Med Res. 2012;40(4):1381-9. doi: 10.1177/147323001204000416.
citation: Kain ZN, Mayes LC, Cicchetti DV, Bagnall AL, Finley JD, Hofstadter MB. The Yale Preoperative Anxiety Scale: how does it compare with a "gold standard"? Anesth Analg. 1997 Oct;85(4):783-8. doi: 10.1097/00000539-199710000-00012.