Screen-Based Distraction Tool for Preoperative Preparation

NCT03014466 | Completed DMC

• 1 other identifier: IRB-37577
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Anxiety

Outcome Measures

Primary Outcomes (1)

• Anxiety at Induction of Anesthesia

  Modified Yale Perioperative Anxiety Score at induction of anesthesia. This is a validated scale used to assess patient periprocedural anxiety

  30 minutes

Secondary Outcomes (1)

• Induction Compliance

  5 minutes

Study Arms (2)

Tablet

ACTIVE COMPARATOR

Preoperative patients will utilize a video tablet for addressing pre anesthesia anxiety

Behavioral: Use of Video Tablet

Video Projector

EXPERIMENTAL

Preoperative patients will utilize a video projection unit for addressing pre anesthesia anxiety

Behavioral: Use of Video Projector

Interventions

Use of Video Projector BEHAVIORAL

Bed mounted video projector that is used to play videos of the patient's choosing prior to induction of anesthesia

Also known as: Bedside Entertainment Theater

Video Projector

Use of Video Tablet BEHAVIORAL

7 inch video tablet that is used for displaying videos of the patient's choosing prior to induction of anesthesia

Tablet

Eligibility Criteria

• Age: 4 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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) -

You may not qualify if:

• 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 -

Sponsors & Collaborators

• Stanford University: lead

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Samuel T Rodriguez, MD

  Stanford School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: January 5, 2017
• First Posted: January 9, 2017
• Study Start: January 1, 2017
• Primary Completion: January 1, 2018
• Study Completion: January 1, 2018
• Last Updated: October 1, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share