REducing Anxiety in CHildren Undergoing Procedures

NCT03054077 | Completed Results

• 1 other identifier: HM200008056
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Ambulatory Surgery

Keywords

pre-procedural anxiety; children; pediatric sedation

Outcome Measures

Primary Outcomes (1)

• Change in Anxiety Scores With the Addition of the iPad Intervention-Comparing Group 1 to Group 2

  The Modified Yale Preoperative Anxiety Scale- Short form (mYPAS-SF) Ratings produce 4 mYPAS scores (1 for each time point) Areas scored: Activity (1,2,3, or 4) Vocalizations (1,2,3,4,5,or 6) Emotional Expressivity (1,2,3, or 4) State of Apparent arousal (1,2,3, or 4) Scoring: Each score is calculated by dividing each item rating by the highest possible rating (i.e., 6 for the "vocalizations" item and 4 for all other items), adding all the produced values, dividing by 5, and multiplying by 100. This calculation produces a score ranging from 23.33 to 100, with higher values indicating higher anxiety. Comparison of scores between Group 1 and Group 2 to see if changes in anxiety scores occurred with the addition of the iPad. All data will be gathered with review at the close of the study which is anticipated to occur in 5/20/2017.

  Immediately following enrollment, immediately before anesthesia, and post-op assessed up to 10 minutes

Study Arms (2)

Control or Group 1

NO INTERVENTION

This group receives standard of care for the child receiving a sedated procedure. There is no intervention for this group.

Intervention group or Group 2

EXPERIMENTAL

This group receives an iPad with downloaded games to play while waiting for the sedation/procedure and then resume play upon return to the recovery area and awakening.

Other: iPad with downloaded games

Interventions

iPad with downloaded games OTHER

iPad with downloaded games will be given to children randomized to group 2 for use during their time in the peri-operative unit

Intervention group or Group 2

Eligibility Criteria

• Age: 4 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Virginia Commonwealth University: lead

Study Sites (1)

Virginia Commonwealth University Health System

Richmond, Virginia, 23298, United States

Location

Related Publications (4)

• 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.

  PMID: 24491647 BACKGROUND

• 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.

  PMID: 25010821 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

• 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.

  PMID: 17197846 BACKGROUND

Results Point of Contact

• Title: Debra Shockey
• Organization: Virginia Commonwealth University

dpshockey@vcu.edu

804-828-3744

Study Officials

• Debbie Shockey, DNP

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Blinding occurs through the randomization. Once the assignment to either group 1 (control) or group 2 (intervention) occurs all participants, care providers and investigators will be aware of which group is which.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 31, 2017
• First Posted: February 15, 2017
• Study Start: March 10, 2017
• Primary Completion: May 19, 2017
• Study Completion: May 19, 2017
• Last Updated: October 10, 2017
• Results First Posted: October 10, 2017

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)