Clinical trial NCT03054077: REducing Anxiety in CHildren Undergoing Procedures
Official title: Reducing Anxiety in Children Undergoing Procedures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ambulatory Surgery
Keywords: pre-procedural anxiety
children
pediatric sedation
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
First posted: 2017-02-15
Enrollment: 24
Sex: ALL
Minimum age (years): 4
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: RCT with a control arm equivalent to current standard of care and an intervention arm that includes standard of care plus the addition of an iPad with downloaded games.
Primary purpose: SUPPORTIVE_CARE

Brief summary: This is a small pilot, feasibility study designed as a quality improvement project. The purpose is to identify anxiety in children aged 4-12 years who will receive a sedated procedure and to see if the use of an iPad as a focused activity will decrease the level of anxiety through a small randomized control trial in the Children's Perioperative Unit.

Detailed description: Description: The study is a quality improvement project and designed as a small pilot randomized control trial. Participants will be randomly assigned to either Group 1 (no intervention) or Group 2 (iPad intervention) via a number generator.

Children randomized to Group 1 receive the standard of care with observation and scoring of the mYPAS-SF occurring at three time points (T1 pre-operative holding area-patient room which is private, T2 induction of anesthesia, T3 awakening from sedation post procedure).

Children randomized to Group 2 will be observed at the same time points (T1, T2, T3) but will additionally interact with an iPad that has a selection of 3 games downloaded (3 games for children ages 4-7 and 3 games for children ages 8-12). The iPad is introduced in between T1 and T2 and then resumed at T3 until discharge from the clinical unit.

Process: Following IRB approval, the steps of the study are:

1. . Subjects meeting inclusion criteria (age, first sedated procedure, English speaking) will be identified through daily review of scheduled patient lists by study team members. (CPU Nurse Champions, PI).
2. . Potential subjects will be approached in a private area when they arrive for the procedure to make sure they meet the eligibility criteria. Information concerning the study will be presented by the CPU Nurse Champion, PI or Research Assistant.
3. . If the family is interested in participating in the study, further explanation and consent and assent (as appropriate) will be obtained by the PI or the Research Assistant from the parent and the child.
4. . A demographic questionnaire will be completed following project consenting and enrollment for both groups.
5. . The mYPAS-SF (screening tool that requires a 30 second observation at three distinct time points) will be completed for both groups.
6. . The iPad will be given to participants randomized to Group 2 T1- Child observed in the private holding room area (observation occurs after getting settled in the private room prior to the procedure)

T2-Child observed prior to the induction of anesthesia (observation occurs just prior to the administration of anesthesia).

T3-Child observed upon return to private holding area and awakening from anesthesia (observation occurs when child awakens from the anesthesia).

Eligibility criteria: Inclusion Criteria:

* Children admitted for a sedated procedure
* Must be first sedated procedure
* English speaking
* ages 4-12

Exclusion Criteria:

* Non English speaking
* Children younger than 4 and older than 12 years
* Children with developmental disabilities

Primary outcomes:
measure: Change in Anxiety Scores With the Addition of the iPad Intervention-Comparing Group 1 to Group 2
timeFrame: Immediately following enrollment, immediately before anesthesia, and post-op assessed up to 10 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University Health System
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Debbie Shockey, DNP
role: PRINCIPAL_INVESTIGATOR
References:
citation: Banchs RJ, Lerman J. Preoperative anxiety management, emergence delirium, and postoperative behavior. Anesthesiol Clin. 2014 Mar;32(1):1-23. doi: 10.1016/j.anclin.2013.10.011.
citation: Jenkins BN, Fortier MA, Kaplan SH, Mayes LC, Kain ZN. Development of a short version of the modified Yale Preoperative Anxiety Scale. Anesth Analg. 2014 Sep;119(3):643-650. doi: 10.1213/ANE.0000000000000350.
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.
citation: Kain ZN, Caldwell-Andrews AA, Mayes LC, Weinberg ME, Wang SM, MacLaren JE, Blount RL. Family-centered preparation for surgery improves perioperative outcomes in children: a randomized controlled trial. Anesthesiology. 2007 Jan;106(1):65-74. doi: 10.1097/00000542-200701000-00013.