Reframing Needle-Related Pain: Randomized Clinical Trial of a Parent-Led Memory-Reframing Intervention
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 77
- 试验地点
- 2
- 主要终点
- Child pain during the second vaccination
研究概览
简要总结
The present research study aims to examine the efficacy of a brief parent-led memory reframing intervention to foster more adaptive (i.e., more accurate and positive) pain memories and less future needle pain and fear for a two-series needle procedure (approved vaccines to protect against COVID-19; e.g., BioNTech Pfizer). The intervention will draw from 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 needle procedure (i.e., a COVID-19 vaccine).
详细描述
Pain is a common experience in childhood. Healthy children who adhere to recommended medical care undergo up to 20 painful procedures by the age of 5. Pain from, and fear of, medical experiences are neither short lasting or benign and 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, and are sometimes more influential to future pain than the initial experience of pain itself. Memory is susceptible to distortion. Negative biases in pain memories (i.e., recalling higher levels of pain as compared to initial pain report) are associated with higher subsequent pain, distress, and worse medical compliance. 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 tend to develop more negatively biased pain memories months later. In particular, adolescents who felt helpless in the face of pain (lack of self-efficacy in their ability to deal with pain) prior to surgery went on to develop more negatively-biased memories. Moreover, parents' catastrophic thinking about child pain was found to be the single most important predictor of children's memory biases and subsequent pain trajectories. It has been suggested that parental and child anxiety lead to memory biases because of the ways in which parents and children talk about pain following painful events (e.g., by emphasizing threatening aspects of the experience). Needle fear and vaccine hesitancy have also been argued to play an important role in children's and parent reactions to needle pain.
There have only been a few studies examining memory reframing interventions in the context of children's recall of (needle) pain. In a systematic review, existing trials of memory reframing interventions were found to be efficacious in reducing negative memory biases, which is thought to be due to increases in self-efficacy. Indeed, 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.
Recent data 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 in a more accurate and positively biased way. In a recently published pilot randomized controlled trial, the investigators demonstrated that a parent-led memory-reframing intervention is efficacious in reducing negative biases in children's memories for post-surgical pain. However, the intervention has not been examined in the context of needle procedures. The potential impact of the intervention on children's future pain experiences has not yet been examined. Finally, the parent-led memory-reframing intervention has only been tested in children aged 4 to 7 years. A recent RCT has demonstrated that a parent-led memory-reframing intervention is feasible and acceptable in youth aged 10 to 18 years undergoing major surgeries. Yet, the intervention efficacy for needle pain in older children is unknown.
The present research study aims to examine the efficacy of a brief parent-led memory reframing intervention to foster more adaptive (i.e., more accurate and positive) pain memories and less future needle pain and fear for a two-series needle procedure (approved vaccines to protect against COVID-19; e.g., BioNTech Pfizer). The intervention will draw from the 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 needle procedure (i.e., a COVID-19 vaccine). All participating parents will receive evidence-based information on pain management techniques. Parents randomized to the control group will receive a pamphlet outlining pain management strategies. Parents randomized to the intervention group will receive this same pamphlet and additionally receive a pamphlet and video link with memory-reframing instructions based on a previously published study. The third group will receive the pamphlet outlining pain management strategies, the memory-reframing pamphlet and video, as well as brief verbal instructions via telephone or zoom on how to deliver the intervention to their children. Parents randomized to the intervention groups will receive text reminders to use the intervention after the vaccine injection.
This study will be the first to test a brief, parent-led intervention aimed at changing the way children recall their pain after a needle procedure and examine the impact of the intervention on children's future needle pain intensity and fear at a second vaccine injection. This study has great potential to contribute an accessible and feasible pediatric pain management intervention and foster more adaptive pain trajectories and medical experiences in childhood.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 4 Years 至 11 Years(Child)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •A child will be eligible to participate if they
- •are aged between 4 and 11 years old at the time of the recruitment;
- •plan to receive a two-dose COVID-19 vaccine;
- •are able to understand and speak English;
- •have at least one of their caregivers' consent to participate in the study, and this caregiver is able to speak and read English
- •have Internet access.
排除标准
- •serious developmental disabilities (e.g., Autism Spectrum Disorder) or speech/language delays, as it may make it difficult for the participants to complete all necessary study tasks (e.g., assent, memory interview);
- •child's or caregiver's inability to speak and/or understand English
结局指标
主要结局
Child pain during the second vaccination
时间窗: 6 to 8 weeks after the first vaccination appointment (subject to change depending on the Canada Health guidelines)
Pain intensity will be assessed using a well-validated single-item faces pain scale (Faces Pain Scale-Revised; FPSR; range of scores 0 to 10; higher scores mean higher levels of pain) by children
Child pain-related fear during the second vaccination
时间窗: 6 to 8 weeks after the first vaccination appointment (subject to change depending on the Canada Health guidelines)
Children's pain-related fear will be assessed using the Children's Fear Scale (CFS; range of scores 0 to 4; higher scores mean higher levels of pain-related fear).
Memory for pain during the first vaccination
时间窗: 7 to 10 days after the first vaccination appointment
Children will be asked to recall the first vaccination appointment and complete a pain intensity rating scale (i.e., Faces Pain Scale-Revised; range of scores 0 to 10; higher scores mean higher levels of pain) based on their memories of that time period. Biases in memory will be defined as the deviation in recalled and initial/experienced pain reports. Similar to our previous research, statistical models predicting pain memories will control for initial pain ratings that correspond to each memory question. Negatively-biased pain memories will be defined as children who remember more pain as compared to their initial pain reports. Positively biased pain memories will be defined as recalled pain that is less than initial pain reports. Accurate memories reflect no difference between recalled and experienced levels of pain.
Memory for pain-related fear during the first vaccination
时间窗: 7 to 10 days after the first vaccination appointment
Children will be asked to recall the first vaccination appointment and complete a pain-related fear rating scale (i.e., Children's Fear Scale; CFS; range of scores 0 to 4; higher scores mean higher levels of pain-related fear) based on their memories of that time period. Biases in memory will be defined as the deviation in recalled and initial/experienced pain-related fear reports. Similar to our previous research, statistical models predicting pain-related fear memories will control for initial pain-related fear ratings that correspond to each memory question. Negatively-biased memories will be defined as children who remember more pain-related fear as compared to their initial pain-related fear reports. Positively biased pain-related fear memories will be defined as recalled pain-related fear that is less than initial pain-related fear reports. Accurate memories reflect no difference between recalled and experienced levels of pain-related fear.
次要结局
- Child and parent self-efficacy(Baseline and 7 to 10 days after the first vaccination appointment)
- Feasibility of intervention (i.e., how many participants assigned to intervention groups received the intervention)(Baseline, pre-intervention, post-intervention, follow-up (i.e., 6 to 8 weeks after the first vaccination appointment))
- Expected pain-related fear(7 to 10 days after the first vaccination appointment)
- Acceptability (i.e., participants' perception of the intervention applicability and usefulness, as well as their satisfaction with the intervention)(6 to 8 weeks after the first vaccination appointment (subject to change depending on the Canada Health guidelines))
- Child self-efficacy(Baseline and 7 to 10 days after the first vaccination appointment)
- Adherence(6 to 8 weeks after the first vaccination appointment (subject to change depending on the Canada Health guidelines))
- Expected pain(7 to 10 days after the first vaccination appointment)
