Geagea Dali, Griffin Bronwyn, Kimble Roy, Polito Vince, Terhune Devin B, Tyack Zephanie
Centre for Children's Burns and Trauma Research, Centre for Children's Health Research, Level 7, 62 Graham Street, South Brisbane, QLD, 4101, Australia.
Faculty of Medicine, The University of Queensland, Brisbane, QLD, 4067, Australia.
Pilot Feasibility Stud. 2022 Mar 9;8(1):58. doi: 10.1186/s40814-022-01017-z.
Burns and related procedures are painful and distressing for children, exposing them to acute and chronic sequelae that can negatively affect their physiological, psychological, and social functions. Non-pharmacological interventions such as distraction techniques are beneficial adjuncts to pharmacological agents for procedural pain, state anxiety, and itch in children with burns but have limitations (e.g. lack of research on burn-related itch, tailoring, and consensus on optimal treatment). Hypnotherapy is a non-pharmacological intervention that can be tailored for varied settings and populations with evidence of benefit for itch and superior effectiveness in comparison to other non-pharmacological interventions for children's procedural pain and state anxiety. Thus, children with burns can benefit from hypnotherapy as an adjunct to pharmacological agents. Yet, in paediatric burns, rigorous studies of effectiveness are limited and no studies have been identified that screen for hypnotic suggestibility, an important predictor of hypnotherapy outcomes. Considering potential barriers to the delivery of hypnotherapy in paediatric burns, the proposed study will examine the feasibility and acceptability of hypnotic suggestibility screening followed by hypnotherapy for procedural pain, state anxiety, and itch in children with acute burns.
An observational mixed-methods feasibility and acceptability study will be conducted over 15 weeks. Eligible children (N = 30) aged 4 to 16 years presenting to a paediatric burns outpatient centre in a metropolitan children's hospital in Australia with acute burns requiring dressing changes will be included. Eligible parents of children (N = up to 30) and clinicians who perform dressing changes (N = up to 20) will also be included. Child participants screened as having medium to high suggestibility as assessed by behavioural measures will receive hypnotherapy during dressing changes. A process evaluation will target feasibility and acceptability as primary outcomes and implementation (i.e. fidelity in delivery), reach, potential effectiveness, and adoption of evaluation procedures and intervention as secondary outcomes.
Ethical approval was obtained from the Queensland Children's Hospital and Health Service ethics committee. Results will be published in peer-reviewed publications and conference proceedings. The findings will guide the design of future trials on the effectiveness of hypnotherapy and inform the development of child-centred hypnotic interventions in children with burns.
Australian New Zealand Clinical Trials Registry ACTRN12620000988954.
烧伤及相关治疗对儿童来说既痛苦又令人苦恼，会使他们面临急性和慢性后遗症，这些后遗症会对其生理、心理和社会功能产生负面影响。非药物干预措施，如分散注意力技巧，对于烧伤儿童的治疗性疼痛、状态焦虑和瘙痒而言，是药物治疗的有益辅助手段，但存在局限性（例如，缺乏关于烧伤相关瘙痒、个性化治疗以及最佳治疗方案共识的研究）。催眠疗法是一种非药物干预措施，可以针对不同的环境和人群进行调整，有证据表明其对瘙痒有益，并且与其他针对儿童治疗性疼痛和状态焦虑的非药物干预措施相比，效果更佳。因此，烧伤儿童可受益于将催眠疗法作为药物治疗的辅助手段。然而，在儿科烧伤领域，关于其有效性的严格研究有限，尚未发现有研究对催眠易感性进行筛查，而催眠易感性是催眠疗法效果的重要预测指标。考虑到儿科烧伤中实施催眠疗法可能存在的障碍，本拟议研究将探讨对急性烧伤儿童进行催眠易感性筛查后再采用催眠疗法治疗治疗性疼痛、状态焦虑和瘙痒的可行性和可接受性。
将在15周内开展一项观察性混合方法可行性和可接受性研究。纳入年龄在4至16岁、前往澳大利亚一家大都市儿童医院的儿科烧伤门诊中心就诊、因急性烧伤需要换药的符合条件的儿童（N = 30）。还将纳入符合条件的儿童家长（N = 最多30名）以及进行换药的临床医生（N = 最多20名）。通过行为测量评估被筛查为具有中度至高易感性的儿童参与者将在换药期间接受催眠疗法。过程评估将以可行性和可接受性作为主要结果，以实施情况（即实施的保真度）、覆盖范围、潜在有效性以及评估程序和干预措施的采用情况作为次要结果。
已获得昆士兰儿童医院和卫生服务伦理委员会的伦理批准。研究结果将发表在同行评审的出版物和会议论文集中。这些发现将指导未来关于催眠疗法有效性试验的设计，并为制定以儿童为中心的烧伤儿童催眠干预措施提供参考。
澳大利亚新西兰临床试验注册中心ACTRN12620000988954。
