Use of Handheld Audiovisual Devices to Treat Pediatric Preoperative Anxiety

NCT ID: NCT02286674

Last Updated: 2022-08-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-11-30
• Study Completion Date: 2017-01-31

Brief Summary

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.

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.

Conditions

Pediatric Preoperative Anxiety

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Tablet for watching movie

The study group will receive standard of care in addition to a tablet to watch movies and/or TV

Group Type: EXPERIMENTAL

Tablet (Audio/Visual Device)

Intervention Type: OTHER

Subjects will be given a tablet to use before surgery

Standard of care - no tablet

The control group will receive standard of care only.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Tablet (Audio/Visual Device)

Subjects will be given a tablet to use before surgery

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

McLaren Health Care

OTHER

Sponsor Role: lead

Responsible Party

MCRI Staff

Michael Stein

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michael Stein, DO

Role: PRINCIPAL_INVESTIGATOR

Physician

Locations

McLaren Greater Lansing Hospital

Lansing, Michigan, United States

Countries

United States

References

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Reference Type: BACKGROUND

PMID: 10320175 (View on PubMed)

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Other Identifiers

201400076

Identifier Type: -

Identifier Source: org_study_id