Comparison of Usual Care and Distraction (Tablet) in Children 3-5 Years Old

NCT05368961 | Completed Results

• 1 other identifier: 16-511
• Study Type: interventional
• Target: 137
• Locations: 1 country
• Sites: 1

Brief Summary

Randomized control trial comparing usual care and distraction (tablet) on anxiety, emergence delirium, sedation/agitation, and vomiting in children 3-5 years old

Conditions

Anxiety

Outcome Measures

Primary Outcomes (1)

• mYPAS Anxiety Score, Patients With Scores of 30 or More Indicated "Anxiety"

  Pre-operative anxiety measured by the modified Yale Preoperative Anxiety Scale (mYPAS); 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" and scores of less than 30 indicated "no anxiety".

  Pre-induction of mask anesthesia in the operating room

Secondary Outcomes (5)

• Sedation/Agitation

  Pre-induction of mask anesthesia in the operating room

• Number of Participants Experiencing Emergence Delirium

  After surgery when patient woke up in the post anesthesia care unit (recovery room)

• Sedation/Agitation

  After surgery at the time of admission to post anesthesia care unit (recovery room)

• Length of Stay (Minutes)

  Post operative until discharged from post anesthesia care unit (recovery room)

• The Number of Patients Experiencing Postoperative Vomiting

  After surgery in the post anesthesia care unit from admission to discharge

Study Arms (2)

Usual care

ACTIVE COMPARATOR

Usual care (midazolam) is administered pre-operatively

Other: Usual care

Distraction

EXPERIMENTAL

Distraction (interactive tablet) is given to children pre-operatively

Behavioral: Distraction

Interventions

Distraction BEHAVIORAL

Distraction (interactive tablet)

Distraction

Usual care OTHER

Anxiolytic ordered by anesthesiologist is usual care

Also known as: Anxiolytic per anesthesia

Usual care

Eligibility Criteria

• Age: 3 Years - 5 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• year old children
• Scheduled for elective surgery
• American Society of Anesthesiologists physical status classification system: I - II

You may not qualify if:

• 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

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Related Publications (3)

• 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.

  PMID: 25040433 BACKGROUND

• 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.

  PMID: 15114210 BACKGROUND

• 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.

  PMID: 15562048 BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Osteogenesis, Distraction

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Bone Lengthening; Orthopedic Procedures; Surgical Procedures, Operative

Results Point of Contact

• Title: Michelle Levay, Nurse Research Manager
• Organization: Cleveland Clinic

levaym@ccf.org

216-445-4749

Study Officials

• Nancy M Albert, PhD

  The Cleveland Clinic

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Not a blinded study
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Group 1: usual care Group 2: distraction

Study Record Dates

• First Submitted: April 28, 2022
• First Posted: May 10, 2022
• Study Start: April 7, 2017
• Primary Completion: March 8, 2019
• Study Completion: March 8, 2019
• Last Updated: April 1, 2024
• Results First Posted: April 1, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)