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

NCT02704442 | Unknown

• 1 other identifier: 6014969
• Study Type: observational
• Target: 82
• Locations: 1 country
• Sites: 1

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

Keywords

anesthesiology; ophthalmology

Outcome Measures

Primary Outcomes (1)

• Change in Compliance with Ophthalmology examination

  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)

  4 days and 6 weeks after surgery

Secondary Outcomes (3)

• 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

• 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 temperament

  pre operative assessment

Eligibility Criteria

• Age: 3 Years - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Queen's University: lead
• University of Regina: collaborator

Study Sites (1)

Hotel Dieu Hospital

Kingston, Ontario, K7L 5G2, Canada

RECRUITING

Related Publications (9)

• 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.

  PMID: 16310653 BACKGROUND

• 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.

  PMID: 16882820 BACKGROUND

• 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.

  PMID: 10320165 BACKGROUND

• 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.

  PMID: 18633018 BACKGROUND

• 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.

  PMID: 9822003 BACKGROUND

• 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.

  PMID: 12635399 BACKGROUND

• 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.

  PMID: 20499223 BACKGROUND

• 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.

  PMID: 22971489 BACKGROUND

• 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.

  PMID: 9322455 BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders; Strabismus; Patient Compliance

Condition Hierarchy (Ancestors)

Mental Disorders; Ocular Motility Disorders; Cranial Nerve Diseases; Nervous System Diseases; Eye Diseases; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Rachel Rooney, MD

  Queen's University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rachel Rooney, MD

CONTACT

613 549-6666; rooneyr@kgh.kari.net

Yi Ning Strube, MD

CONTACT

613 544-3310; strubey@hdh.kari.net

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Rachel Rooney MD FRCPC, Assistant Professor Department of Anesthesiology, Queen's University

Study Record Dates

• First Submitted: February 17, 2016
• First Posted: March 10, 2016
• Study Start: February 1, 2016
• Primary Completion: September 1, 2019
• Study Completion: September 1, 2019
• Last Updated: April 26, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)