Ambulatory Surgery
Conditions
Keywords
pre-procedural anxiety, children, pediatric sedation
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.
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).
Interventions
OTHERiPad 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
Sponsors
Virginia Commonwealth University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
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.
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.
Eligibility
Sex/Gender
ALL
Age
4 Years to 12 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Anxiety Scores With the Addition of the iPad Intervention-Comparing Group 1 to Group 2 | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Control or Group 1 This group receives standard of care for the child receiving a sedated procedure. There is no intervention for this group. | 12 |
| 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.
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 | 12 |
| Total | 24 |
Baseline characteristics
| Characteristic | Control or Group 1 | Intervention Group or Group 2 | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 12 Participants | 12 Participants | 24 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 12 Participants | 12 Participants | 24 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 7 Participants | 4 Participants | 11 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) White | 4 Participants | 7 Participants | 11 Participants |
| Region of Enrollment United States | 12 participants | 12 participants | 24 participants |
| Sex: Female, Male Female | 4 Participants | 3 Participants | 7 Participants |
| Sex: Female, Male Male | 8 Participants | 9 Participants | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 12 | 0 / 12 |
| other Total, other adverse events | 0 / 12 | 0 / 12 |
| serious Total, serious adverse events | 0 / 12 | 0 / 12 |
Outcome results
Primary
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.
Time frame: Immediately following enrollment, immediately before anesthesia, and post-op assessed up to 10 minutes
Population: All participants for whom 3 time points were collected at Baseline T1, T2, and T3
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Control or Group 1 | Change in Anxiety Scores With the Addition of the iPad Intervention-Comparing Group 1 to Group 2 | Time Point 1 | 25 units on a scale |
| Control or Group 1 | Change in Anxiety Scores With the Addition of the iPad Intervention-Comparing Group 1 to Group 2 | Time Point 2 | 28.82 units on a scale |
| Control or Group 1 | Change in Anxiety Scores With the Addition of the iPad Intervention-Comparing Group 1 to Group 2 | Time Point 3 | 34.09 units on a scale |
| Intervention Group or Group 2 | Change in Anxiety Scores With the Addition of the iPad Intervention-Comparing Group 1 to Group 2 | Time Point 1 | 29.69 units on a scale |
| Intervention Group or Group 2 | Change in Anxiety Scores With the Addition of the iPad Intervention-Comparing Group 1 to Group 2 | Time Point 2 | 24.83 units on a scale |
| Intervention Group or Group 2 | Change in Anxiety Scores With the Addition of the iPad Intervention-Comparing Group 1 to Group 2 | Time Point 3 | 26.56 units on a scale |