Nonpharmacologic reduction of periprocedural pain, anxiety, and prescription drug use

非药物减少围手术期疼痛、焦虑和处方药使用

• 批准号: 9345484
• 负责人: ELVIRA Valentina LANG-ANDERSON
• 金额: $ 15万
• 依托单位: HYPNALGESICS, LLC
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-07-01 至 2018-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9345484
• 关键词: Adherence; Aftercare; Algorithms; Anesthetics; Anxiety; Appointment; Back; Behavior; Blinded; Callback; Client satisfaction; Clinic; Clinical; Clinical Trials; Coping Skills; Craniofacial Pain; Critiques; Data; Databases; Dental Care; Dental Schools; Dental Staff; Dentistry; Development; Distress; Drug Prescriptions; Drug usage; Elements; Enrollment; Environment; Evaluation; Feedback; Feeds; Goals; Home environment; Human Resources; Hypnosis; Imagery; Instruction; Intake; Language; Legal patent; Location; Magnetic Resonance Imaging; Measures; Medicine; Monitor; Music; Noise; Online Systems; Operative Surgical Procedures; Opioid; Pain; Pain Clinics; Pain management; Patients; Pattern; Performance; Pharmaceutical Preparations; Pharmacotherapy; Phase; Phase II Clinical Trials; Play; Procedures; Quality Control; Randomized; Relaxation; Research; Resources; Services; Shapes; Site; Source; Specialist; Suggestion; Tablets; Techniques; Testing; Time; Training; Treatment Protocols; Universities; Visit; addiction; anxiety management; approach behavior; base; design; diaries; feeding; improved; interest; overdose death; pilot trial; preference; prototype; retention rate; satisfaction; trial design; willingness

Current pain management techniques in conjunction with the annual >100 million surgical and >300 million dental procedures in US are ineffective and feed into the opioid crisis. The long-term goal is to provide for the patients undergoing these procedures a validated, practical means of nonpharmacologic reduction of the associated pain, anxiety, and need for postprocedural prescription drugs achieved through a Comfort Talk® app. Prior large-scale clinical trials showed that short Comfort Talk® scripts and snippets spoken live by trained procedural personnel at the beginning of invasive procedures change the mode of pain processing and resulted in significant sustained reductions of pain and anxiety, drug use, complications, and procedure time while greatly improving patient satisfaction and resource use. This project assesses whether a personalized Comfort Talk® app can produce similar significant benefits. The objective of Phase I is to design such an app, assess its feasibility and acceptance of clinical use and obtain pilot data to enable definitive testing of the hypothesized benefits in Phase II. Specific Aim 1 pursues design and development of a personalized Comfort Talk® app along a patent-pending algorithm allowing individualization along stylistic preferences location (home, waiting room, procedure suite), situation-specific suggestions, and time available. Time-adjusted snippets will be coalesced with instructions, suggestions for relaxation, situation-specific imagery, pain and anxiety management, optional content, and reorientation to adjust seamlessly to times between 4 min and 2 hrs. An agile approach using Behavior- Driven-Development (BDD) will be used to design and implement features that research suggests to be effective, allowing conjoint input from designers, clinicians and patient feedback to shape the design and exert ongoing quality control by Acceptance-Test-Driven Planning. Aim 2 is execution of a pilot trial at the Craniofacial Pain Center at Tufts University School of Dental Medicine. Sixty patients will randomized to listen to the app (n=30), white noise (n=15), or music (n=15) in clinic and receive download coupon for the app on discharge. Anxiety and pain will be assessed on previously validated scales (0-no anxiety/no pain at all and 10-worst anxiety/pain possible) in clinic and for 7 days after discharge at home via diary. Procedure data, drugs usage, prescriptions, prescription call backs, and satisfaction with treatment and the app will be recorded. Aim 3 will assess the acceptance of the clinical app use and feasibility of the trial design. App usage patterns and acceptance in clinic will be established electronically through background capture and patient feedback. Appeal of the app post procedure will be assessed by percentage of download coupons used in each group, consolidated anonymized app data, and interest in using the app upon return visits. Patients' willingness to enroll and compliance with the respective elements of the pilot trial will be used to determine feasibility of a pivotal Phase 2 trial and aid selection of evaluation measures.

当前的疼痛管理技术与每年1亿英镑的外科手术和3亿英镑的 美国的牙科手术是无效的，助长了阿片类药物危机。我们的长远目标是为 接受这些手术的患者是一种有效的、实用的非药物治疗方法 通过Comfort Talk®实现的相关疼痛、焦虑和术后处方药需求 应用程序。之前的大规模临床试验表明，Short Comfort Talk®脚本和片段由 在侵入性程序开始时受过培训的程序人员改变了疼痛处理的模式 并显著地持续减少疼痛和焦虑、药物使用、并发症和手术 时间，同时大大提高患者满意度和资源利用率。该项目评估一个 个性化的Comfort Talk®应用程序也可以产生类似的显著好处。第一阶段的目标是设计 这样一个应用程序，评估其可行性和临床应用的接受度，并获得试点数据以实现最终的 在第二阶段对假设的益处进行测试。 特定目标1致力于设计和开发个性化Comfort Talk®应用程序，该应用程序正在申请专利 允许沿着风格偏好位置(主页、等候室、程序套件)进行个性化的算法， 针对具体情况的建议，以及可用的时间。经过时间调整的代码片段将与指令合并， 放松的建议，特定情况的图像，疼痛和焦虑的管理，可选的内容，以及 重新定向可无缝调整至4分钟至2小时之间的时间。使用行为的敏捷方法- 驱动开发(BDD)将用于设计和实现研究建议的功能 有效，允许设计师、临床医生和患者反馈的联合输入来塑造设计和 通过验收测试驱动的计划实施持续的质量控制。目标2是执行一项试点试验 塔夫茨大学牙科医学院的头面部疼痛中心。60名患者将随机接受治疗 到诊所的应用程序(n=30)、白噪音(n=15)或音乐(n=15)，并获得应用程序的下载优惠券 出院。焦虑和疼痛将在之前经过验证的量表上进行评估(0-没有焦虑/完全没有疼痛和 10-可能最严重的焦虑/疼痛)在诊所和出院后7天通过日记在家中。程序数据， 药物使用、处方、处方回拨以及对治疗和应用程序的满意度将是 录制好了。AIM 3将评估临床应用程序使用的接受度和试验设计的可行性。APP 将通过背景捕获和电子方式建立临床使用模式和接受度 病人的反馈。APP POST程序的上诉将根据下载优惠券的百分比进行评估 在每个组中使用，整合匿名应用程序数据，以及在回访时使用该应用程序的兴趣。 患者的登记意愿和对试点试验各自要素的遵从性将被用于 确定关键阶段2试验的可行性，并协助选择评估措施。