Clinical trial NCT03110367: Reframe the Pain: A Parent-Led Intervention to Alter Children's Memories for Pain
Official title: Reframe the Pain: A Parent-Led Intervention to Alter Children's Memories for Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Psychology
Pain
Stress
Behavior
Coping
Emotion, Expressed
Lead sponsor: University of Calgary
Sponsor class: OTHER
First posted: 2017-04-12
Enrollment: 25
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will include 90 youth scheduled for a pectus repair or a spinal fusion surgery, surgeries associated with high levels of post-surgical pain, and their parents. They will be recruited at the Alberta Children's Hospital. The timelines and measures to be administered to parents and children are listed below. The timelines will include a baseline assessment (1-3 weeks pre-op), in hospital assessment for several days, 1-2 weeks post-op (acute recovery phase), the 2-4 week post-op clinic visit (memory reframing intervention) and 6 weeks post-op.

Participants will be randomized into three groups:

1. Attention Control Group
2. Normal Reminiscing
3. Intervention Group
Primary purpose: TREATMENT

Brief summary: Pain is a common experience in youth and influences youth long after the painful situations are over. Youth memory of pain after surgery can affect painful experiences in the future. Negative memories and feelings of pain, like remembering more pain than the actual level of pain experienced are linked to anxiety for future surgery. Research has found that children's memories of pain is linked to anxiety, pain-related fear, and confidence. Children's memories for pain can be altered after a visit to the hospital, but only a couple of studies have look at this.

The study will be one of the first to look at how well a parent-led memory reframing intervention to reduce youth's negative memories of surgery. We want to look at how a parent-led memory reframing session on youth's post-surgical pain memory.

The study will include 90 youth who have a chest wall surgery or a spinal fusion surgery at the Alberta Children's Hospital. They will be recruited at the Alberta Children's Hospital. There will be pain tests in the form of surveys 1-3 weeks before surgery, pain monitoring in the hospital for a couple of days, pain monitoring 1-2 weeks after surgery, a clinic visit 2-4 weeks after surgery for a memory reframing session, and pain monitoring 6 weeks after surgery in the form of a telephone interview.

Detailed description: Background:

Children's pain memories are a powerful mechanism underlying subsequent pain experiences. 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 are neither short lasting or benign. Poorly managed pain can result in negatively biased pain memories, fears, and for some children, phobias that persist into adulthood. We have demonstrated that children's pain memories are a more important predictor of subsequent pain than their initial experience of pain itself. Indeed, children's pain memories fully mediated the relation between an initial and a subsequent laboratory pain experience. Our most recent data indicates that children's pain memories 2 months after surgery predict higher levels of post-surgical pain 4-6 months later.

Child and parent factors predict children's pain memory development. Existing research has implicated a number of factors in the development of negatively biased memories in children. Child sleep and language abilities have been shown to influence memory development following stressful and painful events. 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. Parents and adolescents who think in more catastrophic ways about child pain prior to surgery tend to develop more negatively biased pain memories months later. Parent and child anxiety are thought to lead to memory biases because of the ways in which parents and children talk about pain following painful events. However, the influence of parent-child language-based interactions on pain memories has not been demonstrated.

The influence of parents on children's pain memories is greatest in early childhood. To guide future research on children's pain memory development, I published a conceptual developmental framework in the journal PAIN11 outlining the cognitive and social factors that are thought to influence children's pain memory development. Of particular importance is early childhood (ages 4-7 years) when children are most susceptible 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. Our 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.

Parent-child reminiscing influences children's memory development. Although surprisingly understudied in the field of pediatric pain, parent-child language-based interactions about past negative events, play a powerful role in how autobiographical memories of those events are subsequently retrieved and reframed. Parent-child narrative style also influences children's coping and psychological functioning. Young children whose parents are topic-extending and elaborative (e.g., who ask open-ended questions to pull for richer, more detailed accounts of the past) and who use emotional language, have children who are more accurate and detailed in recalling their pasts, which is adaptive. Similarly, our recent data provides strong evidence that parents who reminisce with their children about a recent surgery using a particular style (i.e., more elaborative, less topic-switching) and content (less content about pain, fear, medical procedures; more explanations) have children who later remember pain a more accurate/positively biased way.

Memory reframing interventions lead to children remembering pain in more accurate/positively-biased ways. To date, there have been three trials of memory reframing interventions, all of which were administered by a researcher to children undergoing needle procedures (vaccine injections, dental anesthetic injections, lumbar punctures) within 15 minutes. Our recent systematic review revealed that these interventions were efficacious in altering children's memories of pain to be more accurate/positively biased. Emphasizing and rehearsing positive aspects of a pain memory have also been shown to lead to an enhanced ability of children to forget its negative aspects. However, research has not yet implemented parent-led memory reframing interventions for children's pain; however, we have argued that parents are potentially the most powerful and accessible agents of change. Indeed, our recent data provides strong evidence that the language parents use when reminiscing with children following tonsillectomies influences children's pain memory biases.

Recent data from our lab provides compelling evidence that parents who reminisce with their children about surgery using a particular 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 a more accurate and positively biased way. Parental reminiscing style and content have been effectively targeted in interventions to improve children's memory development, albeit, not yet in the context of pain.To date, research has not examined if memory reframing techniques implemented by parents can alter children's recall of post-surgical pain. Thus, the goal of this research 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. The intervention will draw from our recent data and extant memory reframing and narrative-based intervention techniques to promote more accurate/positive pain memories by teaching parents more adaptive styles of reminiscing with their children about a past surgery. We will accomplish our aims by extending our existing program of research on post-surgical pain memory development of children (aged 4-7 years) and randomly assigning parents to receive a memory reframing intervention or attention control following surgery and subsequently assessing children's memories for pain.

Study aims and hypotheses:

Aim 1.) 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.

Aim 2.) 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.

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, thereby extending memory-reframing techniques to the post-surgical pain context. Given the integral 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.

Methods:

Sample:

Participants will include 90 adolescents scheduled for a pectus repair or spinal fusion, surgeries associated with high levels of post-surgical pain,2 and their parents. They will be recruited at the Alberta Children's Hospital (ACH). We will use a recruitment strategy that is consistent with our studies with clinical samples. Specifically, the recruitment pool will be generated as follows: 1) clinic staff will identify the patients scheduled for pectus repair or spinal fusion surgeries; 2) upon booking of the pre-op clinic visit, the admin staff will obtain permission to contact for research purposes from parents along with contact details; 3) clinic staff will pass on the contact information to the research study team via a secure electronic transfer; 4) the study staff will contact eligible families and screen interested parents and youth for eligibility and address any questions they might have and then set up a time to conduct a consent conference call with parent and child. This consent call will involve a discussion with the parent and child who will participate in the study and a researcher. The researcher will explain the information included in the consent form and provide the opportunity for potential participants to ask questions and clarify understanding. At this time, we will also clearly outline our limits to confidentiality regarding disclosure of abuse, neglect, suicidal ideation and intent, and potential to a minor. These are described on the consent form; however, the consent conference is an excellent opportunity to reiterate and clarify these procedures and issues. For this consent conference, a researcher will email these forms to participants (using REDCap, a secure online web-based application) who can complete them on a computer device. To increase participation, we will also distribute the posters (see Recruitment Poster) within ACH, so that potential participants will have the opportunity to contact us directly to indicate interest in the study. Screening for eligibility and consent procedures will be as described above.

Procedure:

One week before surgery, youth will complete measures of pain, sleep (Adolescent Sleep Wake Scale; ASWS), pain catastrophizing (PCS - Child version), anxiety and depression symptoms (PROMIS-25), quality of life (PedsQL), PTSD symptoms (CPSS-5), sensitivity to pain traumatization (SPTS-Child version), self-efficacy about pain, expectancies about pain and pain-related fear (Numerical Rating Scales; NRS). Parents will complete measures of sleep (Pittsburgh Sleep Quality Index), pain catastrophizing (PCS-Parent version), measures of anxiety, depression and PTSD symptoms (PROMIS-29 and PCL-5), sensitivity to pain traumatization (SPTS-Parent version), self-efficacy about pain, parent responses to child pain (ARCS), expectancies about pain and pain-related fear (NRS), a socio-demographic survey (parent education, child age, household income), preparation that they/their child received about the surgery and what this entailed (e.g., coping skills, pain management), and family history of surgeries.

On the day of surgery and every day after the surgery (until discharge), both youth and parents will report pain characteristics (pain intensity \[NRS\], pain-related fear \[NRS\], pain interference \[PROMIS\], pain unpleasantness \[a Likert scale\], pain catastrophizing \[state\]), state anxiety (NRS), overall affect (NRS), and sleep quality (NRS). Parents will also complete a measure of parent responses to child pain (ARCS). Information regarding analgesic and anesthetic agents administered on the day of surgery will be collected via medical chart review.

At 2-weeks post-surgery, parents and youth will complete the baseline assessment measures.

At 4-weeks post-surgery following their clinic visit, parent-child dyads will be randomized into three groups: an attention control group, a normal reminiscing group, and an intervention 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.

Attention Control Group: Parents and youth in the attention control group will watch a neutral 20-minute video that is not related to surgery (Planet Earth). Importantly, they will not talk about pain or the past surgery experience.

Normal Reminiscing: Parents and youth in the normal reminiscing group will be instructed to reminisce with their children about the in-hospital and post-surgery periods as they normally would.

Intervention Group: Parents and youth in the intervention group will receive instructions about adaptive ways of reminiscing about the in-hospital and post-surgery periods. The intervention will draw from existing narrative-based interventions that have taught parents to reminisce with their children about past negative events in more elaborative and emotion-rich ways (e.g., using more open-ended questions, to follow in on children's answers by providing new details about the event, to talk more about emotions, and to praise children's answers). We will also include elements of 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 providing more explanations for events, using less utterances about pain, fear, and medical procedures, 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. Researchers will also provide suggestions for specific questions and remarks to make while reminiscing. Parents, youth, and researchers will engage in brief role-plays to solidify the techniques, which will be followed by researcher feedback. After this training 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.

At 6-weeks post-surgery, youth and parent will complete a telephone pain memory interview to assess youth's recall of the in-hospital and post-surgery periods.Then, parents in the intervention group will complete a brief semi-structured telephone interview to assess feasibility and acceptability of the intervention.

Eligibility criteria: Inclusion Criteria:

1. Youth between the age of 10 to 18
2. Youth who are scheduled to have a chest wall surgery or a spinal fusion surgery

Exclusion Criteria:

1. Youth with developmental disorders or who are being treated for cancer
2. Youth who have had a chest wall surgery or spinal fusion surgery before
3. Youth who are scheduled for other surgical procedures within 24 hours of the scheduled chest wall surgery or spinal fusion surgery
4. Youth who do not speak fluent English
5. Youth who have two non-fluent English speaking parents (one parent must be fluent in English to participate)
6. Youth who experience chronic pain

Primary outcomes:
measure: Memory Biases
timeFrame: 4 weeks post-operative (for spinal instrumentation surgeries) - 6 weeks post operative (for pectus chest wall surgeries)
Secondary outcomes:
measure: Sleep Quality - Child
timeFrame: At baseline, in hospital assessment (1-5 days after surgery), 1 week post surgery (for spinal instrumentation surgeries) - 2 weeks post surgery (for pectus chest wall surgeries)
measure: Sleep quality - Parent
timeFrame: At baseline, in hospital assessment (1-5 days after surgery), 1 week post surgery (for spinal instrumentation surgeries) - 2 weeks post surgery (for pectus chest wall surgeries)
measure: Pain Intensity
timeFrame: At baseline, in hospital assessment (1-5 days after surgery), 1 week post surgery (for spinal instrumentation surgeries) - 2 weeks post surgery (for pectus chest wall surgeries), telephone interview (6 weeks post operative)
measure: Pain characteristics, unpleasantness, and interference.
timeFrame: At baseline, in hospital assessment (1-5 days after surgery), 1 week post surgery (for spinal instrumentation surgeries) - 2 weeks post surgery (for pectus chest wall surgeries)
measure: Pain-related anxiety.
timeFrame: At baseline, in hospital assessment (1-5 days after surgery), 1 week post surgery (for spinal instrumentation surgeries) - 2 weeks post surgery (for pectus chest wall surgeries), telephone interview (6 weeks post operative)
measure: Post-traumatic stress disorder symptoms - Child
timeFrame: At baseline, in hospital assessment (1-5 days after surgery), 1 week post surgery (for spinal instrumentation surgeries) - 2 weeks post surgery (for pectus chest wall surgeries)
measure: Anxiety and depressive symptoms - child
timeFrame: At baseline, in hospital assessment (1-5 days after surgery), 1 week post surgery (for spinal instrumentation surgeries) - 2 weeks post surgery (for pectus chest wall surgeries)
measure: Physical and psychosocial functioning.
timeFrame: At baseline, in hospital assessment (1-5 days after surgery), 1 week post surgery (for spinal instrumentation surgeries) - 2 weeks post surgery (for pectus chest wall surgeries)
measure: Sensitivity to pain traumatization (Child version).
timeFrame: At baseline, in hospital assessment (1-5 days after surgery), 1 week post surgery (for spinal instrumentation surgeries) - 2 weeks post surgery (for pectus chest wall surgeries)
measure: Catastrophic thinking about pain - Trait (Child)
timeFrame: At baseline, in hospital assessment (1-5 days after surgery), 1 week post surgery (for spinal instrumentation surgeries) - 2 weeks post surgery (for pectus chest wall surgeries)
measure: Catastrophic thinking about pain - State (Child version).
timeFrame: assessment will take place on day 1 post-operative (day after surgical procedure), day 2 post-operative, day 3 post-operative, day 4 post-operative, day 5 post-operative (if applicable - not yet discharged)
measure: Parent responses to child pain.
timeFrame: assessment will take place on day 1 post-operative (day after surgical procedure), day 2 post-operative, day 3 post-operative, day 4 post-operative, day 5 post-operative (if applicable - not yet discharged)
measure: Background variables collected at baseline - child age
timeFrame: collected at baseline
measure: Pain characteristics, unpleasantness, and interference (Subscale)
timeFrame: At baseline, in hospital assessment (1-5 days after surgery), 1 week post surgery (for spinal instrumentation surgeries) - 2 weeks post surgery (for pectus chest wall surgeries)
measure: Post-traumatic stress disorder symptoms - Parent
timeFrame: At baseline, in hospital assessment (1-5 days after surgery), 1 week post surgery (for spinal instrumentation surgeries) - 2 weeks post surgery (for pectus chest wall surgeries)
measure: Sensitivity to pain traumatization (Parent version).
timeFrame: At baseline, in hospital assessment (1-5 days after surgery), 1 week post surgery (for spinal instrumentation surgeries) - 2 weeks post surgery (for pectus chest wall surgeries)
measure: Catastrophic thinking about pain - Trait (Parent)
timeFrame: At baseline, in hospital assessment (1-5 days after surgery), 1 week post surgery (for spinal instrumentation surgeries) - 2 weeks post surgery (for pectus chest wall surgeries)
measure: Catastrophic thinking about pain - State (Parent version).
timeFrame: At baseline, in hospital assessment (1-5 days after surgery), 1 week post surgery (for spinal instrumentation surgeries) - 2 weeks post surgery (for pectus chest wall surgeries)
measure: Anxiety and depressive symptoms - Parent
timeFrame: At baseline, in hospital assessment (1-5 days after surgery), 1 week post surgery (for spinal instrumentation surgeries) - 2 weeks post surgery (for pectus chest wall surgeries)
measure: Background variables collected at baseline - parent age
timeFrame: Collected at baseline
measure: Background variable collected at baseline - parent sex
timeFrame: Collected at baseline
measure: Background variables collected at baseline - child sex
timeFrame: Collected at baseline
measure: Background variables collected at baseline - child school status
timeFrame: Collected at baseline
measure: Background variables collected at baseline - parent race
timeFrame: Collected at baseline
measure: Background variables collected at baseline - child race
timeFrame: Collected at baseline
measure: Background variables collected at baseline - parent marital status
timeFrame: Collected at baseline
measure: Background variables collected at baseline - child marital status
timeFrame: Collected at baseline
measure: Background variables collected at baseline - child education
timeFrame: Collected at baseline
measure: Background variables collected at baseline - parent education
timeFrame: Collected at baseline
measure: Background variables collected at baseline - family income
timeFrame: Collected at baseline
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Alberta Children's Hospital
state: Alberta
Study officials:
References:
citation: Pavlova M, Lund T, Sun J, Katz J, Brindle M, Noel M. A memory-reframing intervention to reduce pain in youth undergoing major surgery: Pilot randomized controlled trial of feasibility and acceptability. Can J Pain. 2022 Jun 9;6(2):152-165. doi: 10.1080/24740527.2022.2058919. eCollection 2022.