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临床试验/NCT03110367
NCT03110367已完成不适用

Reframe the Pain: A Parent-Led Intervention to Alter Children's Memories for Pain

University of Calgary1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2018年1月23日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
25
试验地点
1
主要终点
Memory Biases

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
10 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者
是

入选标准

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

排除标准

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

研究组 & 干预措施

Pain Reframing Intervention

Active Comparator

Participants will be randomized into this group:

  • Memory reframe with parent facilitated by researcher:

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.

干预措施: Pain Reframing Intervention (Behavioral)

Attention Control Group

Sham Comparator

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 this group:

  • Attention control (watch video [Planet Earth] for same amount of time): 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.

干预措施: Attention Control Group (Behavioral)

Normal Reminiscing

No Intervention

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 this group:

  • 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.

结局指标

主要结局

Memory Biases

时间窗: 4 weeks post-operative (for spinal instrumentation surgeries) - 6 weeks post operative (for pectus chest wall surgeries)

Youth and parents will complete telephone memory interviews to assess their pain memories. Specifically, youth will be asked to remember the levels of sensory (pain intensity) and affective (unpleasantness, anxiety) pain experienced after the surgery. Parents will be asked to remember the levels of sensory (pain intensity) and affective (unpleasantness, anxiety) pain they think their children experienced after the surgery. At the beginning of the memory interviews, children and parents will be asked to freely recall anything that they can remember about the pain task. Telephone interviews to assess children's memory for pain have been effectively conducted with youth. Positively biased pain memories will be defined as recalled pain level that is less than the initial pain report. Accurate memories reflect no difference between recalled and experienced pain. Free recall will be coded for both content and tone.

次要结局

  • Pain Intensity(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))
  • Pain characteristics, unpleasantness, and interference.(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))
  • Pain-related anxiety.(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))
  • Physical and psychosocial functioning.(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))
  • Sensitivity to pain traumatization (Child version).(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))
  • Post-traumatic stress disorder symptoms - Child(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))
  • Anxiety and depressive symptoms - child(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))
  • Catastrophic thinking about pain - Trait (Child)(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))
  • Parent responses to child pain.(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))
  • Sleep Quality - Child(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))
  • Sleep quality - Parent(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))
  • Catastrophic thinking about pain - State (Child version).(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))
  • Background variables collected at baseline - child age(collected at baseline)
  • Pain characteristics, unpleasantness, and interference (Subscale)(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))
  • Post-traumatic stress disorder symptoms - Parent(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))
  • Sensitivity to pain traumatization (Parent version).(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))
  • Catastrophic thinking about pain - Trait (Parent)(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))
  • Catastrophic thinking about pain - State (Parent version).(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))
  • Anxiety and depressive symptoms - Parent(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))
  • Background variables collected at baseline - parent age(Collected at baseline)
  • Background variable collected at baseline - parent sex(Collected at baseline)
  • Background variables collected at baseline - parent race(Collected at baseline)
  • Background variables collected at baseline - parent marital status(Collected at baseline)
  • Background variables collected at baseline - child sex(Collected at baseline)
  • Background variables collected at baseline - child school status(Collected at baseline)
  • Background variables collected at baseline - child race(Collected at baseline)
  • Background variables collected at baseline - parent education(Collected at baseline)
  • Background variables collected at baseline - family income(Collected at baseline)
  • Background variables collected at baseline - child marital status(Collected at baseline)
  • Background variables collected at baseline - child education(Collected at baseline)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Melanie Noel

Assistant Professor, University of Calgary

University of Calgary

研究点 (1)

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