Child Life Intervention to Decrease Anxiety in Patients and Caregivers for Outpatient Surgical Intervention
Condition: Surgery
Study type: Interventional

Summary: 
      1. Determine preoperative and postoperative levels of anxiety for pediatric patients ages
           6-17 related to outpatient surgical intervention using the validated Psychosocial Risk
           Assessment in Pediatrics (PRAP) assessment tool, the State-Trait Anxiety Inventory for
           Adults(STAI-AD), and the State-Trait Anxiety Inventory for Children (STAI-CH)

        2. Determine preoperative and postoperative levels of anxiety for parent/guardian of
           pediatric patients ages 6 - 17 related to outpatient surgical intervention using the
           validate PsychosocialRisk Assessment in Pediatrics (PRAP) assessment tool and the
           State-Trait Anxiety Inventory for Adults (STAI-AD).

        3. Assess if additional Child Life intervention offered pre-operatively to one group
           demonstrates differences in PRAP scores compared to control group
    

Detailed description: 
      This is a prospective, interventional study with two groups of patients scheduled for
      outpatient surgery at Ann and Robert H. Lurie Children's Hospital of Chicago. Participants
      eligible for enrollment will be identified and screened upon diagnosis and/or at the time of
      referral for surgery until patient enrollment is completed. Based on a power analysis, using
      average scores and norms for the validated tool with a projected difference of four points
      difference between groups, minimum enrollment is 22 per group, 44 patients total to detect a
      statistically significant difference based on established parameters.

      Potential participants will be identified in the outpatient clinic setting once a physician
      and family has agreed to pursue surgical invention. The research team will consent either
      during clinical evaluation or following surgical consent obtainment. All questions will be
      answered prior to obtaining signed study consent. Once consent is received, Child Life will
      be paged to observe the patient and caregiver along with the physician provider in order to
      observe and assess behavior required to complete the PRAP assessment form. Additionally, the
      patient and parent/guardian will be asked to complete the STAI-CH and STAI-AD assessments as
      appropriate per age. After the completion of the assessments the patient and family will be
      randomly assigned to intervention or control group. Only the Child Life Specialist and
      research staff facilitating the intervention will be unblinded as to which patients are in
      which group, which is necessary for conducting the study. All other study staff will remain
      blinded. For patients randomized to the intervention group, the Child Life specialist will
      reach out via telephone to offer support and expertise in helping prepare their child and
      themselves for outpatient surgery to help decrease anxiety and increase coping. Concepts
      covered will include: developmentally appropriate language for explaining surgery and related
      procedures, potential coping skills to ease separation for caregivers and pediatric patients.
      Additionally, written materials (attached) covering the same information will be sent via
      mail or email covering the same information discussed in the phone conversation to serve as a
      refresher and resource before the day of surgery. On the day of surgery, the patient will
      receive standard of care (SOC) Child Life Services available to all patients. Patients
      randomized to the control group will not receive the preoperative phone call or written
      materials and will only receive SOC Child Life services on the day of surgery.

      After the surgical induction or day of the procedure, the Child Life Specialist will complete
      the PRAP and document in EPIC per SOC procedures. The Child Life Specialist will also attend
      the postoperative and complete the third PRAP based on feedback from the patient,
      family/caregiver and providing surgeon. At this postoperative time the patient and
      parent/guardian will be asked to complete the STAI-CH and STAI-AD assessments as appropriate
      per age for the second time. Once data is collected, analysis will compare PRAP, STAI-CH, and
      STAI-AD scores between groups at all three points on the timeline. Information gained may be
      used to help direct and develop interventions to help decrease patient and family anxiety and
      increase coping related to surgical intervention
    

Intervention name(s): Child Life
Intervention type(s): Behavioral
Intervention description(s): For patients randomized to the intervention group, the Child Life specialist will reach out via telephone to offer support and expertise in helping prepare their child and themselves for outpatient surgery to help decrease anxiety and increase coping. Concepts covered will include: developmentally appropriate language for explaining surgery and related procedures, potential coping skills to ease separation for caregivers and pediatric patients. Additionally, written materials (attached) covering the same information will be sent via mail or email covering the same information discussed in the phone conversation to serve as a refresher and resource before the day of surgery. On the day of surgery, the patient will receive standard of care (SOC) Child Life Services available to all patients.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care