- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02704442
Does Anxiety in Children on the Day of Surgery Impact Compliance in the Ophthalmology Clinic?
Study Overview
Status
Conditions
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 Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Rachel Rooney, MD
- Phone Number: 7827 613 549-6666
- Email: rooneyr@kgh.kari.net
Study Contact Backup
- Name: Yi Ning Strube, MD
- Phone Number: 3100 613 544-3310
- Email: strubey@hdh.kari.net
Study Locations
-
-
Ontario
-
Kingston, Ontario, Canada, K7L 5G2
- Recruiting
- Hotel Dieu Hospital
-
Contact:
- Rachel Phelan, MSc
- Phone Number: 613 549-6666
- Email: phelanr@KGH.KARI.NET
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
4 days and 6 weeks after surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
child observer rated anxiety
Time Frame: 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)
|
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
Time Frame: 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.
|
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
Time Frame: 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.
|
pre operative assessment
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Rachel Rooney, MD, Queen's University
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 6014969
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Anxiety
-
AstraZenecaCompletedAnxiety Disorders | Anxiety | Anxiety Neuroses | Anxiety StatesUnited States
-
Prisma Health-UpstateCompletedAnxiety | Anxiety, Separation | Separation Anxiety | Anxiety Generalized
-
Ann & Robert H Lurie Children's Hospital of ChicagoUniversity of California, Los Angeles; University of CincinnatiRecruitingAnxiety, Separation | Anxiety, Social | Anxiety, GeneralizedUnited States
-
Yale UniversityNational Institute of Mental Health (NIMH)Active, not recruitingGeneralized Anxiety Disorder | Anxiety Disorder of Childhood | Separation Anxiety Disorder of Childhood | Social Anxiety Disorder of ChildhoodUnited States
-
Nazife Begüm KARANCompletedDental Anxiety | Sedative; Anxiety DisorderTurkey
-
Loyola UniversityCompletedAnxiety | Anxiety State | Procedural AnxietyUnited States
-
Eli Lilly and CompanyCompletedAnxiety Neuroses | Anxiety States, Neurotic | Neuroses, AnxietyUnited States, Mexico, South Africa
-
West University of TimisoaraUnknownAnxiety Disorder/Anxiety StateRomania
-
Dr. Nazanin AlaviActive, not recruitingGeneralized Anxiety Disorder | AnxietyCanada
-
ProofPilotFisher WallaceActive, not recruitingGeneralized Anxiety Disorder | Anxiety | Generalized AnxietyUnited States