Comparison of Virtual Reality to Tablet-based Distraction in Children

Sponsor

Loma Linda University (Other)

Overall Status

Completed

CT.gov ID

NCT04414501

Collaborator

(none)

Enrollment

Location

Arms

23.1

Actual Duration (Months)

4.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The proposed study is a prospective randomized trial to be performed in pediatric patient's ages 4 to 10 years undergoing surgical procedures requiring general anesthesia. The purpose is to compare the effectiveness of interactive tablet devices vs. Virtual Reality headsets. The primary outcome measure being patient anxiety at the time of separation. Other comparison measures will include preoperative parent/caregiver anxiety, anesthesia mask acceptance characteristics at the time of induction, and time to fully recover in the post-operative period.

Condition or Disease	Intervention/Treatment	Phase
Anxiety, Separation	Behavioral: Separation Anxiety	N/A

Detailed Description

After receiving IRB approval from our institution and consent from parents or guardians, ASA I or II status children ages 4 - 10 presenting for surgery requiring general anesthesia were recruited for this study. They were assigned to either tablet- or VR-based groups. At our institution, tablet-based distraction is widely used and represents standard practice. Children in this control group were given tablets in the preoperative holding area before transport to the operating room. Content consisted of entertainment apps providing access to music videos, movies and games targeting various age groups.

The study group was given a Virtual Reality Smartphone headset in the preoperative holding area prior to transport to the operating room. This headset was chosen because of its low cost and wide compatibility for a variety of smartphones. The content consisted of several VR environments that the child/parent could choose from.

In both groups, the distraction with tablet or VR was continued throughout separation from caregivers, transport to the operating room, placement of monitors and mask induction of general anesthesia. Anxiety at time of separation was measured by the modified Yale Preoperative Anxiety Scale (mYPAS). Caregiver anxiety was measured using the State-Trait Anxiety Inventory for Adults (STAI). Mask acceptance at induction of anesthesia was determined by using the Mask Acceptance Scale.

Study Design

Study Type:

Interventional

Actual Enrollment :

94 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

A Comparison of Virtual Reality Headset and Touch Screen Tablet for Minimizing Anxiety During Separation From Caregiver and Induction of Anesthesia in Children

Actual Study Start Date :

Apr 30, 2018

Actual Primary Completion Date :

Apr 2, 2020

Actual Study Completion Date :

Apr 2, 2020

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Tablet study group Anxiety at separation from caregiver was measured by the modified Yale Preoperative Anxiety Scale (mYPAS). Caregiver anxiety was measured using the State-Trait Anxiety Inventory for Adults (STAI), a validated self-evaluation questionnaire. Mask acceptance, a functional evaluation of stress at the time of induction, was determined using the Mask Acceptance Scale.	Behavioral: Separation Anxiety Perioperative anxiety is a common, undesirable outcome in pediatric surgical patients and has been associated with adverse outcomes.
Active Comparator: VR study group Anxiety at separation from caregiver was measured by the modified Yale Preoperative Anxiety Scale (mYPAS). Caregiver anxiety was measured using the State-Trait Anxiety Inventory for Adults (STAI), a validated self-evaluation questionnaire. Mask acceptance, a functional evaluation of stress at the time of induction, was determined using the Mask Acceptance Scale.	Behavioral: Separation Anxiety Perioperative anxiety is a common, undesirable outcome in pediatric surgical patients and has been associated with adverse outcomes.

Arm

Intervention/Treatment

Active Comparator: Tablet study group

Anxiety at separation from caregiver was measured by the modified Yale Preoperative Anxiety Scale (mYPAS). Caregiver anxiety was measured using the State-Trait Anxiety Inventory for Adults (STAI), a validated self-evaluation questionnaire. Mask acceptance, a functional evaluation of stress at the time of induction, was determined using the Mask Acceptance Scale.

Behavioral: Separation Anxiety

Perioperative anxiety is a common, undesirable outcome in pediatric surgical patients and has been associated with adverse outcomes.

Active Comparator: VR study group

Behavioral: Separation Anxiety

Perioperative anxiety is a common, undesirable outcome in pediatric surgical patients and has been associated with adverse outcomes.

Outcome Measures

Primary Outcome Measures

Patient anxiety at the time of separation in children before surgical procedures [Preoperative Period]
We will compare modified Yale Preoperative Anxiety Scale (mYPAS) scores between the tablet based distraction group to those in virtual reality group. The mYPAS evaluates 27 items divided into 5 categories: activity, vocalization, emotional expressivity, state of arousal, and use of parent. The score ranges from 23 (low anxiety) to 100 (high anxiety).

Secondary Outcome Measures

additional anxiety scoring techniques [Preoperative period]
Short State-Trait Anxiety Inventory for Adults (STAI). The STAI is a validated self-evaluation questionnaire measuring anxiety with scores ranging from 6 (not at all) to 24 (very much).
Mask acceptance by the patient [Intraoperative period]
Mask Acceptance Scores

Eligibility Criteria

Criteria

Ages Eligible for Study:

4 Years to 10 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Children 4-10 years of age
Undergoing procedure that requires general anesthesia

Exclusion Criteria:

Emergent procedure
ASA III-IV
Patients with facial skin lesions
Patients with significant history of motion sickness
Visually impaired patients
Patients unable to wear a virtual reality headset
Patients receiving pharmacological intervention to decrease preoperative anxiety

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Loma Linda University Medical Center	Loma Linda	California	United States	92354

Sponsors and Collaborators

Loma Linda University

Investigators

Principal Investigator: Elizabeth Ghazal, MD, Loma Linda University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Elizabeth Ghazal, Associate Professor, Loma Linda University

ClinicalTrials.gov Identifier:

NCT04414501

Other Study ID Numbers:

5180036

First Posted:

Jun 4, 2020

Last Update Posted:

Mar 15, 2021

Last Verified:

Mar 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Anxiety, Separation

Study Results

No Results Posted as of Mar 15, 2021