Pain After Tonsillectomy Study
Condition: Pain, Postoperative
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      Pain is a common experience in childhood. Healthy children can undergo up to 20 painful
      procedures by the age of 5. Moreover, millions of children undergo surgery (e.g.,
      tonsillectomies) each year, which is commonly linked to pain and distress. Pain from, and
      fear of, medical experiences are not short lasting. Indeed, they can influence children long
      after the painful situation is over. Children's memories of pain after surgery can affect
      painful experiences in the future. Negative memories of pain (when children remember more
      pain than the actual level of pain experienced) are linked to higher pain and distress. As
      well, children who are more anxious and who experience greater pain are more likely to
      develop negatively biased pain memories, which then leads to greater fear and pain at
      subsequent pain experiences. It has been suggested that the ways in which parents and
      children talk about pain following painful events is important for how children remember the
      pain.

      This study will be one of the first to look at whether a parent-led memory reframing
      intervention can reduce children's negative memories of surgery.

      The study will include 100 children scheduled for a tonsillectomy and one of their parents.
      They will be recruited from the Alberta Children's Hospital. Parents will complete a survey
      1-3 weeks before their child's surgery, and then the child's pain and anxiety will be
      monitored on the day of surgery and for 2 weeks after surgery. Two weeks after surgery, the
      parent and child will come to the hospital and be assigned to a control group or a memory
      reframing session. Six weeks after surgery, parents and children will complete a telephone
      interview.
    

Detailed description: 
      Background:

      Pain is ubiquitous in childhood. Healthy children who are compliant with medical care undergo
      up to 20 painful procedures by the age of 5. Moreover, millions of children undergo surgery
      (e.g., tonsillectomies) each year, which is commonly linked to pain and distress. Pain from,
      and fear of, medical experiences can influence children long after the painful stimulus is
      removed. Children's memories of needle-related, experimental, post-surgical, and procedural
      pain are a powerful predictor of future pain experiences, even more so than the initial pain
      itself. Memory is susceptible to distortion. Negative biases in pain memories (i.e., recalled
      pain is higher than initial pain report) are associated with higher subsequent pain,
      distress, and worse medical compliance. Several factors have been implicated in the
      development of negatively biased pain memories in children. Higher child anxiety and pain are
      linked to negatively biased pain memories, which then leads to greater fear and pain at
      subsequent pain experiences. Parents and adolescents who think more catastrophically about
      child pain prior to surgery tend to develop more negatively biased pain memories months
      later. In fact, parents' catastrophic thinking about child pain was found to be the most
      important predictor of children's memory biases and subsequent pain trajectories.

      Parental and child anxiety may lead to memory biases due to the ways in which parents and
      children discuss pain following painful events (e.g., by emphasizing threatening aspects of
      the experience). The investigators recently published a conceptual developmental framework in
      the journal PAIN outlining cognitive and social factors that may influence children's pain
      memory development. Of particular importance is early childhood (ages 4-7 years) when
      children are most prone to memory biases due to suggestibility effects. It is also during
      this time that parents are most influential in shaping children's cognitions, emotions, and
      behaviors. This model posits that the socio-linguistic context (e.g. parent-child narratives
      about pain) in which pain memories develop is most important in early childhood and sets the
      stage for future pain experiences.

      There have been few studies examining memory reframing interventions in the context of
      children's recall of pain. In a recent systematic review, existing trials of memory reframing
      interventions were found to be efficacious in reducing negative memory biases. Parent-child
      reminiscing about past negative events plays a powerful role in how memories of those events
      are later retrieved and reframed. Parent-child narrative style also influences children's
      coping and psychological functioning. Young children of parents who are topic-extending and
      elaborative (e.g., who ask open-ended questions to pull for more detailed accounts of the
      past) and use emotional language, are more accurate and detailed in recalling their pasts,
      which is adaptive.

      Recent data from the investigators' lab suggests that parents who reminisce with their
      children about surgery using a certain style (e.g., more elaborative, less topic-switching)
      and content (e.g., less content about pain, fear, medical procedures; more explanations) have
      children who later remember post-surgical pain in a more accurate or positively biased way.
      Parental reminiscing style and content have been effectively targeted in interventions to
      improve children's memory development. However, negatively biased memories of post-surgical
      pain, which can lead to persistent pain problems, have not been targeted, despite a need for
      interventions for this pediatric population. Moreover, existing memory reframing
      interventions did not employ parents. Parents are potentially the most powerful and
      accessible intervention agents, and the investigators' recent data provides strong evidence
      that the language parents use when reminiscing with children following surgery influences
      children's pain memory biases.

      The aim of the proposed research study is to conduct a pilot study to examine the preliminary
      efficacy, feasibility, and acceptability of a brief parent-led memory reframing intervention
      following pediatric surgery to foster more adaptive (i.e., less negatively biased) pain
      memories. This study will be the first to develop and pilot test a brief, parent-led
      intervention aimed at changing the way children recall their pain after surgery. Given the
      vital role of pain memories in shaping future pain experiences and the need for interventions
      in the pediatric surgery context, this study has great potential to contribute an accessible
      and feasible post-surgical pediatric pain management intervention and foster more adaptive
      pain trajectories and medical experiences in childhood.

      Study aims:

      Primary Aim: To examine the preliminary efficacy, feasibility, and acceptability of a
      parent-led memory reframing intervention on children's post-surgical pain memories.
      Hypothesis 1: Children in the intervention group will go on to recall post-surgical pain in a
      more accurate or positively biased way as compared to the control group who will remember
      pain in a more negatively biased way. The intervention will be judged by parents to be
      feasible and acceptable.

      Secondary Aim: To examine the influence of baseline individual child and parent
      characteristics on children's pain memories. Hypothesis 2: Children who are more anxious,
      less self-efficacious, have worse sleep quality, and whose parents are more anxious and
      catastrophize more about child pain prior to surgery will subsequently remember pain in a
      more negatively biased way.

      Methods:

      Sample:

      One hundred children (50 intervention, 50 control) between the ages of 4-7 years and one of
      their parents will be recruited from the Ear Nose and Throat (ENT) Clinic at Alberta
      Children's Hospital.

      Procedure:

      Patients will be identified through surgery schedule lists. At entry into the clinic, a
      member of the ENT Clinic will provide potentially eligible patients with information about
      the study. Parents provide permission to be contacted by the research team. A few weeks
      before surgery, a member of the research team will conduct a recruitment phone call with all
      eligible patients' parents to discuss the study. After the recruitment phone call, online
      consent forms will be emailed to interested participants. Parents will provide consent for
      the child's participation; children, who are 7 years old or over or turn 7 during the course
      of participation in the study, will provide assent. One week before surgery, parents will
      complete measures of parent catastrophizing about child pain (PCS-P), child language (CCC2),
      and child sleep (SDSC). For descriptive purposes, parents will report on socio-demographics
      (e.g., child age, household income), preparation that they/their child received about the
      surgery, and family history of tonsillectomies and surgeries. On the day of surgery, measures
      of parental state anxiety (STAI-S) will be obtained as well as children's levels of pain
      intensity (FPS-R) and pain-related fear (CFS). A trained observer will objectively assess
      preoperative child anxiety during anesthesia induction (mYPAS).

      As per standard clinical care: In Day Surgery, all patients will receive Tylenol 15 mg/kg
      orally pre-operatively, unless there is a specific contraindication. One parent may be
      present at anesthesia induction with their child. The child will receive an inhalational
      induction with sevoflurane, oxygen, and nitrous oxide. An intravenous will then be inserted,
      and the child will be maintained on either volatile anesthetic or total intravenous
      anesthetic (TIVA) for the procedure. During the procedure, all patients will receive
      dexamethasone 0.2 mg/kg IV, ondansetron 0.1 mg/kg IV, and morphine for analgesia. All of the
      ENT surgeons will use cautery to the tonsillar bed as their surgical technique for the
      procedure. The child will then be extubated deep or awake at the end of the procedure and
      transferred to the Post-Anesthesia Care Unit (PACU) to recover. Decision to bring a parent or
      caregiver into the PACU will be at the discretion of the PACU nurse and the anesthesiologist.
      Information regarding the surgical technique used and analgesic and anesthetic agents
      administered on the day of surgery will be collected via medical chart review.

      A researcher will obtain ratings of child pain intensity and pain-related fear shortly
      following surgery. Parents will be given and instructed on how to administer these scales so
      that child-reports of pain can be captured at home. Proxy and self-reports of child average
      and worst pain intensity and pain-related fear will be assessed on days 1, 2, 3, 7 and 14
      post-surgery. Proxy-reports of child sleep (SDSC) will be assessed on day 14 post-surgery.
      Parents will also report on the use of analgesics at home. At 2-weeks post-surgery, parents
      and children will come to the PI's research lab at the Alberta Children's Hospital during
      which time they will be randomized into an intervention or control group. Randomization will
      be conducted by an external statistician using a computer random number generator. Allocation
      concealment will be achieved using sequentially numbered, opaque, and sealed envelopes. Group
      allocation will be revealed by a researcher at the outset of the lab visit. During the lab
      visit, parents in both groups will talk to a researcher while another researcher plays with
      the child (e.g., coloring) in a separate room.

      Control Group. Similar to previous narrative and memory interventions, parents in the control
      group will receive instructions from a researcher on how to engage in child-directed play.
      Importantly, they will not talk about pain or the past surgery experience. After this
      20-minute period, parents in the control group will be instructed to reminisce with their
      children about the in-hospital and post-surgery periods as they normally would.

      Intervention Group. Parents in the intervention group will receive instructions from a
      researcher about adaptive ways of reminiscing about the in-hospital and post-surgery periods.
      The intervention will draw from extant interventions that have taught parents to reminisce
      with their children about past negative events in more elaborative and emotion-rich ways
      (e.g., to use more open-ended questions, follow up on children's answers by providing new
      details about the event, talk more about emotions, and praise children's answers). Elements
      of past pain memory reframing interventions and findings from the investigators' recent data
      will also be included. Specifically, parents will be taught to reminisce with their children
      about the in-hospital and post-surgery periods by providing more explanations for events,
      using less utterances about pain, fear, and medical procedures, emphasizing positive aspects
      of the child's surgery memory, and enhancing children's self-efficacy regarding their ability
      to cope with pain. Researchers will also provide suggestions for specific questions and
      remarks to make while reminiscing. Parents and researchers will engage in brief role-plays to
      solidify the techniques, followed by researcher feedback. After this 20-minute period,
      parents in the intervention group will be instructed to reminisce with their children about
      the in-hospital and post-surgery periods using the intervention strategies.

      After parents and children have finished reminiscing, parents in both groups will be asked to
      complete a short survey similar to the one completed at baseline. Three to four weeks after
      surgery, children in both groups will complete a telephone pain memory interview to assess
      children's recall of the in-hospital and post-surgery periods. Then, parents in the
      intervention group will complete a brief telephone interview to assess feasibility and
      acceptability of the intervention.
    

Intervention name(s): Memory Reframing
Intervention type(s): Behavioral
Intervention description(s): The intervention will draw from existing narrative-based interventions, past pain memory reframing interventions and findings from our recent data. Specifically, parents will be taught to reminisce with their children about the in-hospital and post-surgery periods by encouraging children to provide more explanations, using less utterances about pain, avoiding repetitions, emphasizing positive aspects of the child's surgery memory (e.g., when children used coping methods such as deep breathing, when they got a treat), and enhancing children's self-efficacy regarding their ability to cope with pain.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: At 2-weeks post-surgery, parent-child dyads will participate in a lab visit during which time they will be randomized into an intervention or control group. Randomization will be conducted by an external statistician using a computer random number generator. Allocation concealment will be achieved using sequentially numbered, opaque, and sealed envelopes.
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention