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

Virginia Commonwealth University (VCU)

Status: Completed

Conditions: Ambulatory Surgery

Treatments: Other: iPad with downloaded games

Study type: Interventional

Funder types: Other

Identifiers

NCT03054077

HM200008056

Details and patient eligibility

About

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.

Full 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).

Enrollment: 24 patients

Sex: All

Ages: 4 to 12 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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24 participants in 2 patient groups

Control or Group 1

No Intervention group

Description:

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 group

Description:

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.

Treatment:

Other: iPad with downloaded games