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Screen-Based Distraction Tool for Preoperative Preparation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03014466
Recruitment Status : Completed
First Posted : January 9, 2017
Last Update Posted : October 1, 2018
Sponsor:
Information provided by (Responsible Party):
Samuel Rodriguez, Stanford University

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.

Condition or disease Intervention/treatment Phase
Anxiety Behavioral: Use of Video Projector Behavioral: Use of Video Tablet Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Screen-Based Distraction Tool for Preoperative Preparation
Actual Study Start Date : January 2017
Actual Primary Completion Date : January 2018
Actual Study Completion Date : January 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Active Comparator: Tablet
Preoperative patients will utilize a video tablet for addressing pre anesthesia anxiety
Behavioral: Use of Video Tablet
7 inch video tablet that is used for displaying videos of the patient's choosing prior to induction of anesthesia

Experimental: Video Projector
Preoperative patients will utilize a video projection unit for addressing pre anesthesia anxiety
Behavioral: Use of Video Projector
Bed mounted video projector that is used to play videos of the patient's choosing prior to induction of anesthesia
Other Name: Bedside Entertainment Theater




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Induction Compliance [ Time Frame: 5 minutes ]
    Validated score for assessing patient compliance with anesthesia



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   4 Years to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Participants must:

  1. be between ages of 4-10 years of age
  2. have comprehension of instructions in the English language
  3. have parental consent
  4. Pediatric patient must be undergoing non-emergent outpatient surgery at Lucile Packard Children's Hospital
  5. Children who are normally healthy (ASA I) or have a mild systemic disease (ASA II) -

Exclusion Criteria:

General Exclusion Criteria are as follows:

  1. Significant cognitive impairment/developmental delays per parental report or H&P.
  2. 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)
  3. Children currently taking psychotropic mediations will be excluded from this study due to the affect emotion modulation
  4. Strong parental or patient preference for pharmacological anxiolytic
  5. Strong parental or patient preference for specific anxiety-reducing technique
  6. Children born before 32 week gestation
  7. Any indication that the patient may be admitted post-operatively
  8. Child has had previous surgery or has undergone general anesthesia
  9. Parent does not want to be present during transport to the OR or during induction -

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03014466


Sponsors and Collaborators
Stanford University
Investigators
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Principal Investigator: Samuel T Rodriguez, MD Stanford School of Medicine
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Responsible Party: Samuel Rodriguez, Clinical Assistant Professor, Stanford University
ClinicalTrials.gov Identifier: NCT03014466    
Other Study ID Numbers: IRB-37577
First Posted: January 9, 2017    Key Record Dates
Last Update Posted: October 1, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No