Back to resultsComparison of Usual Care and Distraction (Tablet) in Children 3-5 Years Old
Primary Purpose
Anxiety
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Distraction
Usual care
Sponsored by
About this trial
This is an interventional treatment trial for Anxiety
Eligibility Criteria
Inclusion Criteria:
- 3-5 year old children
- Scheduled for elective surgery
- American Society of Anesthesiologists physical status classification system: I - II
Exclusion Criteria:
- Children younger than 3 or older than 6
- Allergy to midazolam
- Cognitive or developmental delays
- American Society of Anesthesiologists physical status classification system: III - VI
- Anesthesia provider determines child is not eligible
- Children that are transferred to ICU after surgery
Sites / Locations
- Cleveland Clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Usual care
Distraction
Arm Description
Usual care (midazolam) is administered pre-operatively
Distraction (interactive tablet) is given to children pre-operatively
Outcomes
Primary Outcome Measures
Anxiety
Pre-operative anxiety measured by the modified Yale Preoperative Anxiety Scale; scores range 23-100 with higher scores indicating greater levels of anxiety. A categorical variable was created using a cut-off score of 30 or more to indicate anxiety. Scores less than 30 indicate no anxiety.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05368961
Brief Title
Comparison of Usual Care and Distraction (Tablet) in Children 3-5 Years Old
Official Title
Comparison of Usual Care and Distraction (Tablet) on Anxiety and Length of Stay Between in Children 3-5 Years Old
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
April 7, 2017 (Actual)
Primary Completion Date
March 8, 2019 (Actual)
Study Completion Date
March 8, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Cleveland Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Randomized control trial comparing usual care and distraction (tablet) on anxiety and length of stay between in children 3-5 years old
Detailed Description
Two group RCT comparing usual care and distraction (tablet) on preoperative anxiety and length of stay in preschool children.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Group 1: usual care Group 2: distraction
Masking
None (Open Label)
Masking Description
Not a blinded study
Allocation
Randomized
Enrollment
99 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Usual care
Arm Type
Active Comparator
Arm Description
Usual care (midazolam) is administered pre-operatively
Arm Title
Distraction
Arm Type
Experimental
Arm Description
Distraction (interactive tablet) is given to children pre-operatively
Intervention Type
Behavioral
Intervention Name(s)
Distraction
Intervention Description
Distraction (interactive tablet)
Intervention Type
Other
Intervention Name(s)
Usual care
Other Intervention Name(s)
Anxiolytic per anesthesia
Intervention Description
Anxiolytic ordered by anesthesiologist is usual care
Primary Outcome Measure Information:
Title
Anxiety
Description
Pre-operative anxiety measured by the modified Yale Preoperative Anxiety Scale; scores range 23-100 with higher scores indicating greater levels of anxiety. A categorical variable was created using a cut-off score of 30 or more to indicate anxiety. Scores less than 30 indicate no anxiety.
Time Frame
Pre-operative
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
3-5 year old children
Scheduled for elective surgery
American Society of Anesthesiologists physical status classification system: I - II
Exclusion Criteria:
Children younger than 3 or older than 6
Allergy to midazolam
Cognitive or developmental delays
American Society of Anesthesiologists physical status classification system: III - VI
Anesthesia provider determines child is not eligible
Children that are transferred to ICU after surgery
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nancy M Albert, PhD
Organizational Affiliation
The Cleveland Clinic
Official's Role
Study Director
Facility Information:
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
25040433
Citation
Seiden SC, McMullan S, Sequera-Ramos L, De Oliveira GS Jr, Roth A, Rosenblatt A, Jesdale BM, Suresh S. Tablet-based Interactive Distraction (TBID) vs oral midazolam to minimize perioperative anxiety in pediatric patients: a noninferiority randomized trial. Paediatr Anaesth. 2014 Dec;24(12):1217-23. doi: 10.1111/pan.12475. Epub 2014 Jul 17.
Results Reference
background
PubMed Identifier
15114210
Citation
Sikich N, Lerman J. Development and psychometric evaluation of the pediatric anesthesia emergence delirium scale. Anesthesiology. 2004 May;100(5):1138-45. doi: 10.1097/00000542-200405000-00015.
Results Reference
background
PubMed Identifier
15562048
Citation
Kain ZN, Caldwell-Andrews AA, Maranets I, McClain B, Gaal D, Mayes LC, Feng R, Zhang H. Preoperative anxiety and emergence delirium and postoperative maladaptive behaviors. Anesth Analg. 2004 Dec;99(6):1648-1654. doi: 10.1213/01.ANE.0000136471.36680.97.
Results Reference
background
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Comparison of Usual Care and Distraction (Tablet) in Children 3-5 Years Old
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