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REducing Anxiety in CHildren Undergoing Procedures (REACH-UP!)

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ClinicalTrials.gov Identifier: NCT03054077
Recruitment Status : Completed
First Posted : February 15, 2017
Results First Posted : October 10, 2017
Last Update Posted : October 10, 2017
Sponsor:
Information provided by (Responsible Party):
Virginia Commonwealth University

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.

Condition or disease Intervention/treatment Phase
Ambulatory Surgery Other: iPad with downloaded games Not Applicable

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).


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: Single (Investigator)
Masking Description: 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.
Primary Purpose: Supportive Care
Official Title: Reducing Anxiety in Children Undergoing Procedures
Actual Study Start Date : March 10, 2017
Actual Primary Completion Date : May 19, 2017
Actual Study Completion Date : May 19, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
No Intervention: Control or Group 1
This group receives standard of care for the child receiving a sedated procedure. There is no intervention for this group.
Experimental: Intervention group or Group 2
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
iPad with downloaded games will be given to children randomized to group 2 for use during their time in the peri-operative unit




Primary Outcome Measures :
  1. Change in Anxiety Scores With the Addition of the iPad Intervention-Comparing Group 1 to Group 2 [ Time Frame: Immediately following enrollment, immediately before anesthesia, and post-op assessed up to 10 minutes ]

    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.




Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03054077


Locations
United States, Virginia
Virginia Commonwealth University Health System
Richmond, Virginia, United States, 23298
Sponsors and Collaborators
Virginia Commonwealth University
Investigators
Principal Investigator: Debbie Shockey, DNP Virginia Commonwealth University
  Study Documents (Full-Text)

Documents provided by Virginia Commonwealth University:

Publications:
Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT03054077     History of Changes
Other Study ID Numbers: HM200008056
First Posted: February 15, 2017    Key Record Dates
Results First Posted: October 10, 2017
Last Update Posted: October 10, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No anticipated sharing IPD

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Virginia Commonwealth University:
pre-procedural anxiety
children
pediatric sedation