Anxiety
Conditions
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
Detailed description
Two group RCT comparing usual care (midazolam) and distraction (tablet) on preoperative anxiety, emergence delirium, sedation/agitation, and vomiting in preschool children 3-5 years old.
Interventions
BEHAVIORALDistraction
Distraction (interactive tablet)
OTHERUsual care
Anxiolytic ordered by anesthesiologist is usual care
Sponsors
The Cleveland Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
Not a blinded study
Intervention model description
Group 1: usual care Group 2: distraction
Eligibility
Sex/Gender
ALL
Age
3 Years to 5 Years
Healthy volunteers
Yes
Inclusion criteria
* 3-5 year old children * Scheduled for elective surgery * American Society of Anesthesiologists physical status classification system: I - II
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| mYPAS Anxiety Score, Patients With Scores of 30 or More Indicated Anxiety | Pre-induction of mask anesthesia in the operating room | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sedation/Agitation | Pre-induction of mask anesthesia in the operating room | Sedation/agitation was assessed using the Richmond Agitation Sedation Scale (RASS) The RASS scale is a 10-item observational tool. Scores on RASS range from negative 5 (unarousable) to positive 4 (combative/violent). For this study, we categorized the RASS scores as agitated, calm, or sedated. Scores of 2 or higher indicated agitation, scores of +1 to -1 were calm, and scores of -2 or lower indicated sedation. |
| Number of Participants Experiencing Emergence Delirium | After surgery when patient woke up in the post anesthesia care unit (recovery room) | Postoperatively pediatric patients were assessed for emergence delirium using the Pediatric Anesthesia Emergence Delirium (PAED) tool. The scale uses a 5-point Likert scale with total scores ranging from 0 - 20. This study used a score of 12-20 to indicate the presence of emergence delirium. |
| Length of Stay (Minutes) | Post operative until discharged from post anesthesia care unit (recovery room) | Length of stay (total minutes) = time patient admitted to post anesthesia care unit (recovery room) until discharged from post anesthesia care unit. |
| The Number of Patients Experiencing Postoperative Vomiting | After surgery in the post anesthesia care unit from admission to discharge | The number of participants that vomited in the post-anesthesia care unit (from the time they were admitted until they were discharged). |
Countries
United States
Participant flow
Recruitment details
Children ages 3-5 years were recruited from the pre-operative area at a single surgery site between April 2017 to March 2019.
Participants by arm
| Arm | Count |
|---|---|
| Usual Care Usual care (midazolam) is administered pre-operatively
Usual care: Anxiolytic ordered by anesthesiologist is usual care | 47 |
| Distraction Distraction (interactive tablet) is given to children pre-operatively
Distraction: Distraction (interactive tablet) | 52 |
| Total | 99 |
Baseline characteristics
| Characteristic | Usual Care | Distraction | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 47 Participants | 52 Participants | 99 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Customized 3 years old | 24 Participants | 22 Participants | 46 Participants |
| Age, Customized 4 years old | 16 Participants | 15 Participants | 31 Participants |
| Age, Customized 5 years old | 7 Participants | 15 Participants | 22 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 3 Participants | 4 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 2 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants | 2 Participants | 6 Participants |
| Race (NIH/OMB) White | 39 Participants | 45 Participants | 84 Participants |
| Sex: Female, Male Female | 15 Participants | 24 Participants | 39 Participants |
| Sex: Female, Male Male | 32 Participants | 28 Participants | 60 Participants |
| Type of surgery Ear Nose Throat | 20 Participants | 30 Participants | 50 Participants |
| Type of surgery General Surgery | 4 Participants | 2 Participants | 6 Participants |
| Type of surgery Ophthalmology | 13 Participants | 18 Participants | 31 Participants |
| Type of surgery Urology | 10 Participants | 2 Participants | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 47 | 0 / 52 |
| other Total, other adverse events | 0 / 47 | 0 / 52 |
| serious Total, serious adverse events | 0 / 47 | 0 / 52 |
Outcome results
Primary
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.
Time frame: Pre-induction of mask anesthesia in the operating room
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Care | mYPAS Anxiety Score, Patients With Scores of 30 or More Indicated Anxiety | 20 Participants |
| Distraction | mYPAS Anxiety Score, Patients With Scores of 30 or More Indicated Anxiety | 22 Participants |
p-value: 0.44Wilcoxon (Mann-Whitney)
Secondary
Length of Stay (Minutes)
Length of stay (total minutes) = time patient admitted to post anesthesia care unit (recovery room) until discharged from post anesthesia care unit.
Time frame: Post operative until discharged from post anesthesia care unit (recovery room)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Usual Care | Length of Stay (Minutes) | 88.0 Minutes |
| Distraction | Length of Stay (Minutes) | 75.5 Minutes |
Secondary
Number of Participants Experiencing Emergence Delirium
Postoperatively pediatric patients were assessed for emergence delirium using the Pediatric Anesthesia Emergence Delirium (PAED) tool. The scale uses a 5-point Likert scale with total scores ranging from 0 - 20. This study used a score of 12-20 to indicate the presence of emergence delirium.
Time frame: After surgery when patient woke up in the post anesthesia care unit (recovery room)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Care | Number of Participants Experiencing Emergence Delirium | 7 Participants |
| Distraction | Number of Participants Experiencing Emergence Delirium | 8 Participants |
Secondary
Sedation/Agitation
Sedation/agitation was assessed using the Richmond Agitation Sedation Scale (RASS) The RASS scale is a 10-item observational tool. Scores on RASS range from negative 5 (unarousable) to positive 4 (combative/violent). For this study, we categorized the RASS scores as agitated, calm, or sedated. Scores of 2 or higher indicated agitation, scores of +1 to -1 were calm, and scores of -2 or lower indicated sedation.
Time frame: Pre-induction of mask anesthesia in the operating room
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Usual Care | Sedation/Agitation | Sedated | 1 Participants |
| Usual Care | Sedation/Agitation | Calm | 42 Participants |
| Usual Care | Sedation/Agitation | Agitated | 4 Participants |
| Distraction | Sedation/Agitation | Sedated | 0 Participants |
| Distraction | Sedation/Agitation | Calm | 45 Participants |
| Distraction | Sedation/Agitation | Agitated | 7 Participants |
Secondary
Sedation/Agitation
Sedation/agitation was assessed using the Richmond Agitation Sedation Scale (RASS) The RASS scale is a 10-item observational tool. Scores on RASS range from negative 5 (unarousable) to positive 4 (combative/violent). For this study, we categorized the RASS scores as agitated, calm, or sedated. Scores of 2 or higher indicated agitation, scores of +1 to -1 were calm, and scores of -2 or lower indicated sedation.
Time frame: After surgery at the time of admission to post anesthesia care unit (recovery room)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Usual Care | Sedation/Agitation | Sedated | 45 Participants |
| Usual Care | Sedation/Agitation | Calm | 0 Participants |
| Usual Care | Sedation/Agitation | Agitated | 2 Participants |
| Distraction | Sedation/Agitation | Sedated | 48 Participants |
| Distraction | Sedation/Agitation | Calm | 3 Participants |
| Distraction | Sedation/Agitation | Agitated | 1 Participants |
Secondary
The Number of Patients Experiencing Postoperative Vomiting
The number of participants that vomited in the post-anesthesia care unit (from the time they were admitted until they were discharged).
Time frame: After surgery in the post anesthesia care unit from admission to discharge
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Care | The Number of Patients Experiencing Postoperative Vomiting | 1 Participants |
| Distraction | The Number of Patients Experiencing Postoperative Vomiting | 2 Participants |