Reduction of Perioperative Anxiety Using a Hand-held Video Game Device
Condition: Separation Anxiety; Anxiety; Anxiety, Separation; Anxiety Generalized
MeSH terms: Anxiety Disorders; Anxiety, Separation
Study type: Interventional

Summary: 
      Distraction techniques, such as use of a virtual reality device, have been used to augment or
      replace pharmacological practices for relief of anxiety in pediatric patients prior to
      surgical procedures. This relief can not only benefit medical staff, as procedures may be
      easier to perform and require less time, but also have a calming effect on the the parent
      during the procedure if they feel that their child is being better cared for. In addition,
      decreased anxiety prior to surgical procedures have been shown to reduce maladaptive
      behaviors post-operatively. This prospective study plans to evaluate the anxiety level of
      parents and pediatric patients in an outpatient surgery center pre-, during and
      post-operatively with and without the use of a virtual reality distraction device. The goal
      is to determine the existence of correlations between distraction techniques (in this case,
      the use of handheld video games) pediatric patient anxiety, parental anxiety, and parental
      satisfaction with the experience surrounding the procedure.
    

Detailed description: 
      General Data will be collected for patients being treated at Patewood Outpatient Surgery
      Center following legal guardian consent. Patients receiving surgical treatment involving the
      use of an anesthesia mask, age 4 to 10, will be included in the study. Exclusion criteria
      will include ear tube cases, patients physically incapable to play a video game, patients of
      non-English speaking caregivers, and patients without legal guardian present day of surgery.
      IV Ear tube cases are too short a procedure for data collection and at least one caretaker
      must be capable of taking both an oral and written survey.

      For the purposes of this study, a "caregiver" will be defined as an adult that spends a
      significant amount of time with the patient, and meets the following criteria.

      The primary caregiver is the adult that is responsible for the minor patients' care. The
      caregiver may reside with the patient full-time or part-time but have the information
      necessary to assess the child's behavior before and after the outpatient procedure.

      Data collected for each patient will include demographics, random placement in Video Game/No
      Video game group, surgical procedure, information normally recorded by surgeon or
      anesthesiologist including duration of surgery and duration under anesthesia, caregiver
      reported changes in patient behavior following surgery, and scores of the anxiety being felt
      by caregivers and patients. Anxiety scores will be determined using shortened versions of
      validated anxiety scoring assessments. Behavioral changes will be recorded using a shortened
      version of the Post Hospital Behavior Questionnaire (PHBQ). Assessments have been shortened
      to increase study participation, and eliminate any impact the study may have had on
      day-to-day operations at Patewood Outpatient Surgery Center.

      Caregivers will also be asked to fill out a hospital created survey related to how satisfied
      they are with the care of the patient. It will be referred to as the Preoperative Hospital
      Satisfaction Survey (PHSS). This survey will be administered while the surgical procedure is
      in progress, when the caregivers are sitting in the waiting room. The survey is to be a
      reflection of how caregivers perceive preoperative separation care given to patients, so will
      not be influenced by surgical outcome.

      Consent Legal guardians of patients are contacted over the phone by Patewood Outpatient
      Surgery Center registration per standard preoperative care procedure. Before concluding the
      normal preoperative interview, a script will be read that introduces the guardian to the
      study and its goals. The guardian will then be asked if they are interested in learning more
      about the study. Those who answer "no" will be removed from a list of potential participants.
      Those who answer "yes" or "maybe" will be given more information about study participation
      after arriving at the outpatient surgery center on the day of their scheduled appointment. A
      more thorough explanation of the study will be given and any questions answered. If a
      guardian is interested in participating, they will be provided a consent form to fill out.

      Group assignment Patients will be assigned into a "Video Game group" or a "No Video Game
      group." All patients on any particular day will be assigned into the same group. This is done
      to prevent one patient from feeling disappointed after seeing another patient with a video
      game, and then learning they may not have one. Group assignment will alternate each day.

      Assessment and Survey Descriptions

      Modified Yale Preoperative Scale (mYPAS)- Observational survey used to quickly score the
      anxiety level of children during preoperative holding and induction of anesthesia. It has
      frequent use and validation as an accurate tool for determining the anxiety level of
      pediatric surgical patients. Each section has 4 to 6 numbers listed, each corresponding with
      different patient description. For each section, the number by the most accurate patient
      description is circled. (Jenkins)(Kain)

      State Trait Anxiety Inventory (STAI)- Self-taken survey for adults. Gives 2 different scores.
      One score is an indicator of susceptibility to stressful situations, the other score is the
      level of anxiety felt while taking the survey. It has frequent use and validation as a tool
      for determining anxiety levels of adults. (Spielberger)

      Post Hospital Behavior Questionnaire (PHBQ)- Survey taken by primary caregiver of a patient
      after leaving the hospital. The survey is designed to identify maladaptive behaviors a
      patient has developed following a time at a hospital. Questions must be answered "much less
      than before", "less than before", "same as before", "more than before", or "much more than
      before". This survey is sensitive only to the change in frequency of behaviors, not their
      presence or absence. Therefore, undesirable behavior existing prior to a hospital stay should
      have no influence on the PHBQ score.

      All surveys used in this study were truncated. Any modification was evaluated and approved by
      the staff psychologist (PhD.) familiar with using surveys to research anxiety and stress of
      patients and their families. Any questions that were included or excluded from the surveys
      was done so under expert direction.

      Perioperative Holding After completing standard preoperative procedure, a nurse will complete
      a short observational survey (mYPAS [modified Yale Preoperative Scale] or mYPAS-SF) to score
      the patients current anxiety level. Just prior to separation from the caregiver, the patient
      will be given (or not given) a Video Game by the nurse. During separation, another mYPAS will
      be scored.

      Operating Room Another mYPAS will be scored during the induction of anesthesia. If the
      patient has a video game, the patient is allowed to play as long as he/she wants. Often
      times, this is up until the procedure begins.

      Caregivers During Procedure One or two primary caregivers will be asked to fill out a
      shortened STAI (State Trait Anxiety Inventory) and PHSS.

      Follow-up Phone Calls The day following surgery, standard postoperative care procedure will
      be followed. This includes a phone call to the caregiver of a patient. Before concluding the
      phone call, the instructions at the top of the shortened PHBQ will be read to the caregivers
      participating in the survey. Then each question will be read and answered. One week and 2
      weeks following surgery, the caregiver will be called and the shortened PHBQ will be
      administered.

      Statistics The existence of correlations between maladaptive behavior, patient anxiety,
      caregiver susceptibility to anxiety, caregiver experience of anxiety, caregiver satisfaction,
      video game use, and any other collected data will be determined. All information from this
      study will be used to describe our cohort only. All data will be expressed in summary and is
      meant to contribute to the generalizable knowledge of the field.
    

Intervention name(s): Hand-held video game device
Intervention type(s): Other
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Patients will be assigned into a "Video Game group" or a "No Video Game group." All patients on any particular day will be assigned into the same group. This is done to prevent one patient from feeling disappointed after seeing another patient with a video game, and then learning they may not have one. Group assignment will alternate each day.
Masking: Double (Participant, Care Provider)
Primary purpose: Supportive Care
Keywords: anxiety; separation fear