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

目前的疼痛管理技术结合每年> 1亿次手术和> 3亿次 美国的牙科手术是无效的，并助长了阿片类药物危机。长期目标是提供 接受这些手术的患者是一种经验证的，实用的非药物性减少 通过Comfort Talk®实现相关疼痛、焦虑和术后处方药需求 附录之前的大规模临床试验表明，简短的Comfort Talk®脚本和片段由 侵入性手术开始时训练有素的手术人员改变了疼痛处理模式 并导致疼痛和焦虑，药物使用，并发症和程序的显着持续减少 同时大大提高患者满意度和资源利用率。该项目评估了 个性化的Comfort Talk®应用程序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使用的接受程度，并获得试点数据， 在第二阶段测试假设的益处。 Specific Aim 1致力于设计和开发个性化的Comfort Talk®应用程序，沿着正在申请专利的 算法允许个性化沿着风格偏好位置（家、候诊室、手术室）， 针对具体情况的建议和可用的时间。经过时间调整的片段将与指令合并， 放松建议，特定情境的意象，疼痛和焦虑管理，可选内容，以及 重新定向以无缝地调整到4分钟和2小时之间的时间。使用行为的敏捷方法- 驱动开发（BDD）将被用于设计和实现研究表明 有效，允许来自设计师、临床医生和患者反馈的联合输入来塑造设计， 通过验收测试驱动计划来实施持续的质量控制。目标2是在 塔夫茨大学牙科医学院颅面疼痛中心。60名患者将随机接受 应用程序（n=30）、白色噪声（n=15）或音乐（n=15），并在以下网站上获得应用程序的下载优惠券 放电焦虑和疼痛将根据先前验证的量表进行评估（0-无焦虑/完全无疼痛， 10-最严重的焦虑/疼痛可能），出院后7天通过日记在家。程序数据， 药物使用，处方，处方回电，以及对治疗的满意度，应用程序将 记录。目标3将评估临床应用程序使用的可接受性和试验设计的可行性。App 将通过后台采集以电子方式建立诊所的使用模式和接受度， 患者反馈。上诉的应用程序后的程序将被评估的百分比下载优惠券 在每个组中使用，合并匿名应用程序数据，并在回访时使用应用程序的兴趣。 患者的入组意愿和对初步试验各要素的依从性将用于 确定关键2期试验的可行性，并帮助选择评估措施。

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.