Anxiety
Conditions
Brief summary
Pediatric anxiety upon induction of anesthesia is widely prevalent and can lead to negative patient psychological impact and hindrance to induction of anesthesia. Historically, premedication has been used as one means to improve pediatric preoperative anxiety and cooperation with induction. However, giving medication to children prior to surgery has drawbacks. Thus, other means have been proposed that may have similar benefits but fewer or different drawbacks. Recently, audiovisual distraction in the form of interactive games has been proposed. Such games have been in use at children's hospitals around the United States for more than five years. This study is a randomized trial that will explore using interactive games to improve pediatric perioperative anxiety in elective surgery compared with standard-of-care not including games. Perioperative anxiety with be evaluated using an observational scale.
Interventions
DEVICEBedside Entertainment and Relaxation Theater (BERT)
BERT is a Nebula Capsule Max portable projector that creates a familiar theater experience designed for children to divert attention away from procedures. It is fitted with a remote control that can be utilized to manage on-screen activities. BERT can be used with any wall, ceiling, or projector screen to create the theater experience with a large screen. It can also be used with assist devices, such as steering wheel and noise-canceling headphones.
Sponsors
Yale University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Masking description
In the first phase (baseline measurement) neither participant nor investigator will be aware of the subjects group assignment. After this phase, due to the nature of the intervention, the experimental group will be aware they are in the intervention group when they see the gaming system.
Eligibility
Sex/Gender
ALL
Age
4 Years to 14 Years
Healthy volunteers
Yes
Inclusion criteria
* 4 to 14 years of age; * Undergoing non-emergent surgery at Yale New Haven Children's Hospital requiring general anesthesia; * Chooses inhalational induction as induction method; * Surgery qualified under one or more of the following fields: otolaryngology, ophthalmology, orthopedics, dentistry, gastrointestinal, general surgery
Exclusion criteria
* Altered mental status; * Significant audiovisual deficits (per parent report and at discretion of study team); * Received pharmacologic premedication
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Anxiety Assessed by Modified Yale Perioperative Anxiety Score (mYPAS) | Baseline at OR entry (approximately 1 hour after baseline) and At Induction of Anesthesia (approximately 65 minutes after baseline), | The mYPAS is the gold standard for measuring pediatric perioperative anxiety. It is an observational-based 22-item instrument divided into five categories: activity, emotional expressivity, state of arousal, vocalization, and use of parents. The score ranges from 23 to 100, higher scores suggest higher levels of anxiety. It was developed at Yale University. This will be used for child participants only. Results presented here are mean change from baseline in anxiety during induction and upon Operating Room (OR) entry. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change in Caretaker Anxiety Assessed by Short State Anxiety Inventory Score | Baseline, After Induction of Anesthesia (approximately 1 hour after baseline) | The Short State Anxiety Inventory is a 6-item validated measure of anxiety in subjects aged 5 years and older. Subjects are asked to rate how they felt on a 4-point Likert scale in relation to feeling calm, tense, upset, relaxed, content, or worried. A score of 1 correlates to not at all and a score of 4 correlates to very much. The final score is the sum of recorded values and ranges from 6 to 24, higher scores suggest higher levels of anxiety. This will be collected for caretakers only. |
| Healthcare Professional Opinions on BERT Assessed With Health Professional Survey | During first 10 study days | This survey will obtain health care providers' opinions on the usefulness of using the BERT system in reducing anxiety and the feasibility of such a program in a health care setting. Eligible individuals include: physicians, physician assistants/advanced practice providers, nurses, and other operating room staff. |
| Patient Induction Compliance Assessed by Induction Compliance Checklist | At Induction of Anesthesia | The Induction Compliance Checklist is a validated 10-item observer-rated checklist of behaviors that interfere with induction of anesthesia. The score is the sum of the items checked. A perfect induction (the child does not exhibit negative behaviors, fear, or anxiety) is scored as 0, whereas the worst induction is a score of 9. A score greater than six is considered poor compliance. This will be collected for child participants only. |
Countries
United States
Participant flow
Pre-assignment details
One participant randomized to experimental arm did not receive intervention
Participants by arm
| Arm | Count |
|---|---|
| Interactive Gaming Group Subjects will utilize an interactive gaming platform via the Bedside Entertainment and Relaxation Theater (BERT) directly prior to and during induction of anesthesia.
Bedside Entertainment and Relaxation Theater (BERT): BERT is a Nebula Capsule Max portable projector that creates a familiar theater experience designed for children to divert attention away from procedures. It is fitted with a remote control that can be utilized to manage on-screen activities. BERT can be used with any wall, ceiling, or projector screen to create the theater experience with a large screen. It can also be used with assist devices, such as steering wheel and noise-canceling headphones. | 74 |
| Standard of Care Subjects will be offered standard of care interventions to improve preoperative anxiety. The interactive gaming system under investigation will not be available to this group. | 74 |
| Healthcare Professionals Health care providers' will be asked their opinions on the usefulness of AVG in reducing anxiety and the feasibility of such a program in a health care setting. | 30 |
| Total | 178 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Did not receive intervention | 1 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 2 | 0 | 0 |
Baseline characteristics
| Characteristic | Interactive Gaming Group | Standard of Care | Total | Healthcare Professionals |
|---|---|---|---|---|
| Age, Continuous Caregivers | 37.8 years STANDARD_DEVIATION 6.1 | 37 years STANDARD_DEVIATION 7 | 37.4 years STANDARD_DEVIATION 6.07 | — |
| Age, Continuous Child participants | 7.35 years STANDARD_DEVIATION 2.04 | 6.43 years STANDARD_DEVIATION 1.98 | 6.89 years STANDARD_DEVIATION 2.05 | — |
| Caregiver Relationship to Participant Other | 3 Participants | 0 Participants | 3 Participants | — |
| Caregiver Relationship to Participant Parent | 34 Participants | 37 Participants | 71 Participants | — |
| Caregiver Surgical History, Previous Surgery No | 14 Participants | 9 Participants | 23 Participants | — |
| Caregiver Surgical History, Previous Surgery Yes | 23 Participants | 28 Participants | 51 Participants | — |
| Ethnicity (NIH/OMB) Hispanic or Latino | 13 Participants | 13 Participants | 26 Participants | — |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 21 Participants | 24 Participants | 45 Participants | — |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 3 Participants | 0 Participants | 3 Participants | — |
| Healthcare Professional Title Anesthesiologist | 0 Participants | 0 Participants | 5 Participants | 5 Participants |
| Healthcare Professional Title Anesthesiology Resident/Fellow | 0 Participants | 0 Participants | 8 Participants | 8 Participants |
| Healthcare Professional Title Certified Registered Nurse Anesthetist (CRNA) | 0 Participants | 0 Participants | 3 Participants | 3 Participants |
| Healthcare Professional Title Circulating Nurse | 0 Participants | 0 Participants | 6 Participants | 6 Participants |
| Healthcare Professional Title Scrub Technologist | 0 Participants | 0 Participants | 3 Participants | 3 Participants |
| Healthcare Professional Title Surgery Resident/Fellow | 0 Participants | 0 Participants | 5 Participants | 5 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | — |
| Race (NIH/OMB) Asian | 1 Participants | 4 Participants | 5 Participants | — |
| Race (NIH/OMB) Black or African American | 7 Participants | 5 Participants | 12 Participants | — |
| Race (NIH/OMB) More than one race | 2 Participants | 2 Participants | 4 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 | 1 Participants | 2 Participants | — |
| Race (NIH/OMB) White | 26 Participants | 25 Participants | 51 Participants | — |
| Region of Enrollment United States | 37 participants | 37 participants | 74 participants | — |
| Sex: Female, Male Caregivers Female | 29 Participants | 32 Participants | 61 Participants | — |
| Sex: Female, Male Caregivers Male | 8 Participants | 5 Participants | 13 Participants | — |
| Sex: Female, Male Child Participants Female | 18 Participants | 17 Participants | 35 Participants | — |
| Sex: Female, Male Child Participants Male | 19 Participants | 20 Participants | 39 Participants | — |
| Short State Anxiety Inventory Score at baseline | 10.5 score on a scale STANDARD_DEVIATION 5.3 | 11.4 score on a scale STANDARD_DEVIATION 3.1 | 10.95 score on a scale STANDARD_DEVIATION 3.3 | — |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 74 | 0 / 74 | 0 / 30 |
| other Total, other adverse events | 0 / 74 | 0 / 74 | 0 / 30 |
| serious Total, serious adverse events | 0 / 74 | 0 / 74 | 0 / 30 |
Outcome results
Primary
Patient Anxiety Assessed by Modified Yale Perioperative Anxiety Score (mYPAS)
The mYPAS is the gold standard for measuring pediatric perioperative anxiety. It is an observational-based 22-item instrument divided into five categories: activity, emotional expressivity, state of arousal, vocalization, and use of parents. The score ranges from 23 to 100, higher scores suggest higher levels of anxiety. It was developed at Yale University. This will be used for child participants only. Results presented here are mean change from baseline in anxiety during induction and upon Operating Room (OR) entry.
Time frame: Baseline at OR entry (approximately 1 hour after baseline) and At Induction of Anesthesia (approximately 65 minutes after baseline),
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Interactive Gaming Group | Patient Anxiety Assessed by Modified Yale Perioperative Anxiety Score (mYPAS) | Induction | 5 score on a scale | Standard Deviation 18.3 |
| Interactive Gaming Group | Patient Anxiety Assessed by Modified Yale Perioperative Anxiety Score (mYPAS) | OR entry | 0.18 score on a scale | Standard Deviation 9.7 |
| Standard of Care | Patient Anxiety Assessed by Modified Yale Perioperative Anxiety Score (mYPAS) | Induction | 21.4 score on a scale | Standard Deviation 22.1 |
| Standard of Care | Patient Anxiety Assessed by Modified Yale Perioperative Anxiety Score (mYPAS) | OR entry | 8.9 score on a scale | Standard Deviation 10.7 |
Comparison: Inductionp-value: <0.001t-test, 2 sided
Comparison: OR entryp-value: <0.001t-test, 2 sided
Secondary
Healthcare Professional Opinions on BERT Assessed With Health Professional Survey
This survey will obtain health care providers' opinions on the usefulness of using the BERT system in reducing anxiety and the feasibility of such a program in a health care setting. Eligible individuals include: physicians, physician assistants/advanced practice providers, nurses, and other operating room staff.
Time frame: During first 10 study days
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Interactive Gaming Group | Healthcare Professional Opinions on BERT Assessed With Health Professional Survey | Rated BERT system very favorable or favorable for continued use | 97 percentage of participants |
| Interactive Gaming Group | Healthcare Professional Opinions on BERT Assessed With Health Professional Survey | Believe system benefited children | 97 percentage of participants |
| Interactive Gaming Group | Healthcare Professional Opinions on BERT Assessed With Health Professional Survey | Believe system benefited caregivers | 90 percentage of participants |
| Interactive Gaming Group | Healthcare Professional Opinions on BERT Assessed With Health Professional Survey | Believe system benefited staff | 70 percentage of participants |
| Interactive Gaming Group | Healthcare Professional Opinions on BERT Assessed With Health Professional Survey | Did not find system disruptive | 70 percentage of participants |
Secondary
Mean Change in Caretaker Anxiety Assessed by Short State Anxiety Inventory Score
The Short State Anxiety Inventory is a 6-item validated measure of anxiety in subjects aged 5 years and older. Subjects are asked to rate how they felt on a 4-point Likert scale in relation to feeling calm, tense, upset, relaxed, content, or worried. A score of 1 correlates to not at all and a score of 4 correlates to very much. The final score is the sum of recorded values and ranges from 6 to 24, higher scores suggest higher levels of anxiety. This will be collected for caretakers only.
Time frame: Baseline, After Induction of Anesthesia (approximately 1 hour after baseline)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Interactive Gaming Group | Mean Change in Caretaker Anxiety Assessed by Short State Anxiety Inventory Score | -0.18 score on a scale | Standard Deviation 3.2 |
| Standard of Care | Mean Change in Caretaker Anxiety Assessed by Short State Anxiety Inventory Score | 1.89 score on a scale | Standard Deviation 2.84 |
p-value: 0.022t-test, 2 sided
Secondary
Patient Induction Compliance Assessed by Induction Compliance Checklist
The Induction Compliance Checklist is a validated 10-item observer-rated checklist of behaviors that interfere with induction of anesthesia. The score is the sum of the items checked. A perfect induction (the child does not exhibit negative behaviors, fear, or anxiety) is scored as 0, whereas the worst induction is a score of 9. A score greater than six is considered poor compliance. This will be collected for child participants only.
Time frame: At Induction of Anesthesia
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Interactive Gaming Group | Patient Induction Compliance Assessed by Induction Compliance Checklist | 1.0 score on a scale | Standard Deviation 2.2 |
| Standard of Care | Patient Induction Compliance Assessed by Induction Compliance Checklist | 2.1 score on a scale | Standard Deviation 2.5 |
p-value: 0.046t-test, 2 sided