Screen-Based Distraction Tool for Preoperative Preparation
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Stanford University
- Enrollment
- 60
- Primary Endpoint
- Anxiety at Induction of Anesthesia
Study Overview
Brief Summary
Preoperative anxiety in pediatric patients undergoing surgical procedures has been previously shown to increase the likelihood of family stressors, post- operative pain, agitation, sleep disturbances, and negative behavioral changes. The purpose of this study is to determine whether the use of a bed mounted Video Projection unit (i.e. BERT, Bedside EnterRtainment Theater) is more effective than the use of a standard of care tablet (i.e., iPad) for preventing anxiety before surgery among children undergoing anesthesia and surgery. The anticipated primary outcome will be reduction of child's anxiety in the preoperative and operating room setting and compliance with mask induction.
Detailed Description
Patients will initially be approached about the study during a pre-surgical phone call that every patient receives prior to their procedure by a Nurse Practitioner (NP). During this phone call, the NP will ask if the family would be interested in participating in a research study and if they may be contacted by the research team. If the family expresses interest, the NP will follow-up with the research team and a eligibility screening phone call will be given. If families decline interest, we will respect their decision and will not pursue the family any further for this study. Not all families will be available during the initial pre- surgical phone call, and in this case, the medical staff member and research assistant will approach the family in the pre-operative holding area day of surgery. Interested families will be given a brochure with information about the study and screened for eligibility.
Upon arrival for preoperative preparations, the research assistant will go over the consent and assent forms with the parent and child and answer any questions they may have about the study. While child is being prepped to be transported to the preoperative holding area, a research staff member will determine whether the participant will receive the standard care (i.e. entertainment via tablet) or the (i.e. BERT, Bedside EnteRtainment System; Video Projection) via random assignment. Once determined, the research staff will set up the system for the patient and will be asked to fill out questionnaires, on REDCap or by paper, about how they are feeling at that time before their surgery. Parents will also be asked to fill out questionnaires about their feelings of their child's preoperative emotions. The child will continue to view their preoperative entertainment through to induction. A video camera mounted to the BERT screen or tablet will be used for retrospective coding by blinded research assistants. When possible, a blinded research assistant will also live-code the observer-rated surveys. We aim for this to occur for around 20-30% of participants. care) The research assistants will complete the mYPAS (modified Yale Preoperative Anxiety Scale) and ICC (Induction Compliance Checklist) when coding in vivo. Vitals (i.e. blood pressure, heart rate, oxygen saturation, end tidal CO2, and temperature) will also be recorded as they undergo preoperative preparations. The parent will be asked to remain with their child from the preoperative holding area until the child has undergone induction. Once child enters induction phase in the OR, the patient will undergo surgery as scheduled.
Post-operation, the research assistant will further examine the child's behaviors as they wake from anesthesia. They will also give the the parent, child, and child's anesthesiologist a survey about their experiences with the screen-based device. 1 week after the surgery, the research assistant will follow up with the parent/guardian with questions about their and their child's preoperative and perioperative via phone. The call will also be audio recorded. After the one-week follow-up survey, the study will be concluded for the participant.
b) Explain how the above research procedures are the least risky that can be performed consistent with sound research design.
All survey questions are meant to answer questions pertaining to the study aims. Set up of the Video Projection unit will be performed by trained members of the research team and will be of minimal risk to patients.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 4 Years to 10 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Participants must:
- •be between ages of 4-10 years of age
- •have comprehension of instructions in the English language
- •have parental consent
- •Pediatric patient must be undergoing non-emergent outpatient surgery at Lucile Packard Children's Hospital
- •Children who are normally healthy (ASA I) or have a mild systemic disease (ASA II) -
Exclusion Criteria
- •General Exclusion Criteria are as follows:
- •Significant cognitive impairment/developmental delays per parental report or H&P.
- •Children with ASA III, ASA IV (severe systemic disease that is a constant threat to life) or ASA V (unstable patients not expected to survive >24hours or without the operation)
- •Children currently taking psychotropic mediations will be excluded from this study due to the affect emotion modulation
- •Strong parental or patient preference for pharmacological anxiolytic
- •Strong parental or patient preference for specific anxiety-reducing technique
- •Children born before 32 week gestation
- •Any indication that the patient may be admitted post-operatively
- •Child has had previous surgery or has undergone general anesthesia
- •Parent does not want to be present during transport to the OR or during induction -
Arms & Interventions
Tablet
Preoperative patients will utilize a video tablet for addressing pre anesthesia anxiety
Intervention: Use of Video Tablet (Behavioral)
Video Projector
Preoperative patients will utilize a video projection unit for addressing pre anesthesia anxiety
Intervention: Use of Video Projector (Behavioral)
Outcomes
Primary Outcomes
Anxiety at Induction of Anesthesia
Time Frame: 30 minutes
Modified Yale Perioperative Anxiety Score at induction of anesthesia. This is a validated scale used to assess patient periprocedural anxiety
Secondary Outcomes
- Induction Compliance(5 minutes)
Investigators
Samuel Rodriguez
Clinical Assistant Professor
Stanford University