Use of Handheld Audiovisual Devices to Treat Pediatric Preoperative Anxiety

August 23, 2022 updated by: MCRI Staff, McLaren Health Care

Use of Handheld Audiovisual Devices to Treat Pediatric Preoperative Anxiety: A Randomized Control Trial.

Anxiety in children undergoing surgery is a central concern to both parents and healthcare workers, including nurses, surgeons, and anesthesiologists. It has been ranked by anesthesiologists as one of the top five important low-morbidity anesthesia outcomes (1). This study would determine whether such devices would decrease anxiety in children prior to induction of anesthesia for outpatient surgery. Two hundred children ages 2-12 will be enrolled.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Anxiety in children undergoing surgery is a central concern to both parents and healthcare workers, including nurses, surgeons, and anesthesiologists. It has been ranked by anesthesiologists as one of the top five important low-morbidity anesthesia outcomes (1). Extensive research has been done characterizing, quantifying, and risk stratifying anxiety in this group as well as identifying a multitude of treatment options both pharmacological and nonpharmacological. Up to 60% of all children develop anxiety in the preoperative holding area and during anesthetic induction (2). The incidence can be much higher in some subpopulations. Preoperative anxiety has been attributed to number of causes including separation from parents and uncertainty about anesthesia, the procedure, and outcome (3).

Interestingly, anxiety prior to surgery has effects that extend into the intraoperative, acute recovery and subacute recovery timeframes. Patients with high levels of preoperative anxiety have been found to require greater anesthetic dosages (4). There is a higher incidence of emergence delirium in children with higher levels of preoperative anxiety (5, 6). These patients also have with a higher incidence of postoperative pain and require more analgesic medications (7). Furthermore, there are well documented maladaptive behavioral changes that can occur in 30-54% of children two weeks following surgery (8). These include generalized anxiety, nighttime crying, enuresis, separation anxiety, and temper tantrums. Twenty percent of these children maintain this behavior at 6 months and 7% persist at 1 year after the operation (9). High preoperative anxiety levels correlate with these behavior changes (2, 5, 8,10).

Many other interventions have been tried to decrease anxiety with varying success. Most are aimed at distraction. Music therapy appears to be therapist-dependent (12). Hand held video games appear to help decrease anxiety, even during induction (13). Even having clowns in the operating room at induction of anesthesia seems to help -- the study concluded that staff were quite resistant to maintaining the clown program (14). Interestingly, a small randomized controlled trial showed that parents distracting their children during induction with novel toys and books or blowing bubbles did not decrease anxiety (15).

Few studies have considered the use of tablets as distraction tools for children undergoing surgery. Low and Pittaway briefly described using an iPhone™ to distract 93 children in the preoperative period (16). However, the results are simply anecdotal. Patel et al. described a randomized control trial using hand held video games as a means of distraction compared to midazolam and a control group. They used the well validated and extensively used modified Yale Preoperative Anxiety Score (17) to measure anxiety levels. However, this study included parents being present at induction in all the groups, which may make the results difficult to apply at the majority of institutions, where parental presence is not used - our institution included (11).

In addition, premedication may be given to 50% of patients nationally, but it is not popular among parents (11,18). If the majority of practitioners do not use parental presence at induction, preoperative education programs are not yet in widespread use and half of patients are not premedicated, that leaves a significant portion of the population with little intervention for the time of separation and for time of induction of anesthesia. Finding an economical, efficient means to help decrease anxiety without high doses of premedication would be quite appealing.

This study would determine whether such devices would decrease anxiety in children prior to induction of anesthesia for outpatient surgery. Two hundred children ages 2-12 will be enrolled. Half would be in the control group, which would receive standard care. Half would be in the study group, which would receive a tablet device in the preoperative holding area and would be allowed to watch TV or movies from a preloaded list until they are given anesthetic gases in the operating room. The subjects would be observed for outward signs of anxiety and scored using a well validated and well used anxiety scale, the modified Yale preoperative anxiety scale, at several points in time prior to induction of anesthesia. The expected total study length is 6 months based on the current number of pediatric cases at the study site.

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Lansing, Michigan, United States, 48910
        • McLaren Greater Lansing Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

7 months to 10 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Ages 2-12
  2. Outpatient surgery procedures
  3. ASA I of II (No or mild systemic disease)
  4. Parental/guardian ability to understand and willingness to sign written informed consent
  5. Patient assent to use tablet, if they are randomized to the study group
  6. Anesthetic plan includes sevoflurane inhalation induction as determined by the anesthesiologist

Exclusion Criteria:

  1. Psychoactive medications (e.g. antipsychotics, mood stabilizers, anxiolytics, antidepressants, narcotics)
  2. Diagnosed psychiatric disease
  3. Developmental disabilities
  4. History of photosensitive seizures
  5. Patient requiring sedative or narcotic medications prior to induction of anesthesia, as determined by the anesthesiologist.
  6. Parental/guardian inability to understand or refusal to sign written informed consent
  7. Patient unwillingness or inability to use tablet
  8. Anesthetic plan does not include sevoflurane induction, as determined by anesthesiologist.
  9. Non English speaking patient and/or parent/guardian

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Tablet for watching movie
The study group will receive standard of care in addition to a tablet to watch movies and/or TV
Other: Tablet (Audio/Visual Device)
Subjects will be given a tablet to use before surgery
No Intervention: Standard of care - no tablet
The control group will receive standard of care only.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Yale Preoperative Anxiety Score
Time Frame: Baseline
Anytime prior to patient being ifnormed of group assignment
Baseline
Yale Preoperative Anxiety Score
Time Frame: Upon patient spearation from parents Approx 15-20 minutes
Approx 15-20 minutes after the study group participants receive a tablet
Upon patient spearation from parents Approx 15-20 minutes
Yale Preoperative Anxiety Score
Time Frame: Patient enters operating room 1-32 minutes
1-32 minutes after #2
Patient enters operating room 1-32 minutes
Yale Preoperative Aniety Score
Time Frame: Placement of face mask on patient ofr anesthetic delivery 1-2 minutes
1-2 minutes after #3
Placement of face mask on patient ofr anesthetic delivery 1-2 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

McLaren Health Care

Investigators

  • Principal Investigator: Michael Stein, DO, Physician

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2014

Primary Completion (Actual)

November 1, 2016

Study Completion (Actual)

January 1, 2017

Study Registration Dates

First Submitted

October 10, 2014

First Submitted That Met QC Criteria

November 7, 2014

First Posted (Estimate)

November 10, 2014

Study Record Updates

Last Update Posted (Actual)

August 25, 2022

Last Update Submitted That Met QC Criteria

August 23, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201400076

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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