Healthcare Provider Behavior and Children's Perioperative Distress
Condition: Pain, Postoperative; Infant Behavior
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      The goal of this randomized trial is to examine the effectiveness of a Provider Tailored
      Intervention for Perioperative Stress (P-TIPS) in preventing high anxiety and improving the
      recovery process in children undergoing surgery. Four hospitals and all Healthcare Providers
      (HCP) in it will be randomized to either a P-TIPS Group, who will receive the newly developed
      intervention, or a Control Group who will receive a 2-hour seminar on the management of
      preoperative anxiety and postoperative pain and otherwise will provide standard care. The
      aims of this study are to:

      PRIMARY AIM

      1. Determine if P-TIPS is more effective than standard care for preventing high preoperative
      anxiety among children undergoing anesthesia and surgery. The primary outcome will be
      observational anxiety in the operating room settings as measured by m-YPAS (modified-Yale
      Preoperative Anxiety Scale).

      SECONDARY AIMS

        1. Examine the impact of P-TIPS on surgical recovery parameters such as postoperative pain,
           recovery room stay, nausea and vomiting, emergence delirium and maladaptive behavioral
           changes as measured by the PAED, and PHBQ

        2. Determine if the use of P-TIPS results in higher satisfaction and lower anxiety scores
           in the parents.as measured by the STAIs, STAIt and Parent Satisfaction questionnaires

        3. Determine if HCP in P-TIPS group display more desired behaviors and less undesired
           behaviors as compared to control group and whether these behaviors mediate the child and
           parent-level outcomes.These behaviors will be measured using the m-PCAMPIS
    

Detailed description: 
      The proposed clustered randomized trial of four children's hospitals: CHOC Children's (CHOC),
      Children's Hospital Los Angeles (CHLA), Lucile Packard Children's Hospital at Stanford, The
      Children's Hospital, Denver. At each hospital approximately 20 anesthesia and nursing health
      care providers (HCP) will examine the effectiveness of a Provider Tailored Intervention for
      Perioperative Stress (P-TIPS) aimed at preventing high anxiety and improving the recovery
      process in children undergoing surgery via modifying adults' behavior. Each hospital and all
      HCP in it will be randomized to either a P-TIPS Group, who will receive the newly developed
      intervention, or a Control Group who will receive a 2-hour seminar on the management of
      preoperative anxiety and postoperative pain and otherwise will provide standard care.
      Objective measures of children's preoperative anxiety and postoperative recovery, as well as
      adherence measures of HCP will be collected prior and during the experimental period.

      HCP in the Intervention group will learn that the use of behaviors as such distraction and
      medical reinterpretation directs the child's attention towards more enjoyable topics or
      reframes the procedure into something less threatening, which in turn diverts the child's
      attention away from their own distress or fear. Conversely, although HCPs often use
      reassurance and empathy to help soothe children, the education that HCPs receive from P-TIPS
      will explain that these emotion-focused comments seem to direct children's attention to their
      own distress and frightening aspects of the medical procedure. HCPs will also learn the
      intricacies of implementing these strategies and ways to adjust their behavior to effectively
      keep children engaged in coping related behaviors.

      Child's anxiety m-YPAS during induction is assessed at two points, a) entering the operating
      room and b) introduction of the anesthesia mask to the child. Once in the OR, the child's
      blood pressure and heart rate is also assessed. A total of 10 child-parent dyad interactions
      per HCP are collected for the baseline assessment phase. HCP behavior during induction is
      also videotaped by research assistants and coded later using the P-CAMPIS measure. Also,
      parents and children answer baseline questionnaires aimed at capturing demographics, anxiety,
      health beliefs. Postoperative analgesic consumption, behavioral and recovery measures are
      also collected.
    

Intervention name(s): Provider Tailored Intervention for Perioperative Stress
Intervention type(s): Behavioral
Intervention description(s): Provider Tailored Intervention for Perioperative Stress (P-TIPS) is developed based on the proximal-distal theory that suggested that in acute procedural settings specific adult behaviors directly affect children's distress and coping behaviors. P-TIPS aims at reducing preoperative anxiety in children via modifying adults' behavior.
Other intervention name(s): P-TIPS
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Pediatric; Pain; Postoperative; General Anesthesia; Anesthesia Recovery Period; Infant Behavior; Adolescent Behavior; Patient Satisfaction