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 亿次手术和 >3 亿次手术相结合 美国的牙科手术无效，并加剧了阿片类药物危机。长期目标是解决这一问题。 接受这些手术的患者是一种经过验证的、实用的非药物减少方法 通过 Comfort Talk® 解决相关疼痛、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，简短的 Comfort Talk® 脚本和片段是由现场说出的。 在侵入性手术开始时训练有素的手术人员改变了疼痛处理的模式 并导致疼痛和焦虑、药物使用、并发症和手术的显着持续减少 时间，同时大大提高患者满意度和资源利用。 个性化的 Comfort Talk® 应用程序可以产生类似的显着效益 第一阶段的目标是设计。 这样的应用程序，评估其可行性和临床使用的接受度，并获取试点数据以实现最终的结果 测试第二阶段所利用的效益。 具体目标 1 致力于设计和开发个性化的 Comfort Talk® 应用程序以及正在申请专利的 算法允许根据风格偏好位置（家、候诊室、手术室）进行个性化， 针对特定情况的建议和可用时间调整的片段将与说明合并在一起。 放松建议、针对具体情况的意象、疼痛和焦虑管理、可选内容以及 重新定位以无缝调整 4 分钟到 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、民兵和患者反馈的联合输入来塑造设计和 目标 2 是在 塔夫茨大学牙科医学院颅面疼痛中心将随机安排 60 名患者聆听。 到诊所的应用程序 (n=30)、白噪音 (n=15) 或音乐 (n=15) 并在以下位置接收该应用程序的下载优惠券 焦虑和疼痛将按照之前验证的量表进行评估（0-无焦虑/完全无疼痛，并且 通过日记记录在诊所和出院后 7 天内可能发生的 10 种最严重的焦虑/疼痛情况。 使用情况、处方、处方药回电以及对治疗和应用程序的满意度将 目标 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。 诊所的使用模式和接受度将通过后台捕获和电子化方式确定 患者对应用程序术后反馈的吸引力将根据下载优惠券的百分比进行评估。 每组的使用情况、整合的匿名应用程序数据以及回访时使用该应用程序的兴趣。 患者参加试验的意愿以及对试点试验各个要素的遵守情况将被用于 确定关键的第二阶段试验的可行性并帮助选择评估措施。