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年度> 1亿外科手术和3亿 我们内心的牙科手术无效，并陷入阿片类药物危机。长期目标是提供 接受这些程序的患者是验证的，实用的非药物减少手段 相关的疼痛，焦虑以及通过ComfortTalk®实现的后期药物处方药的需求 应用程序。先前的大规模临床试验表明，Short ComfortTalk®脚本和摘要现场 在入侵程序开始时，受过训练的程序人员改变了疼痛处理的方式 并导致疼痛和焦虑，药物使用，并发症和程序的持续持续减少 时间大大提高了患者满意度和资源的使用。该项目评估是否 个性化的ComfortTalk®应用程序可以产生类似的重大好处。第一阶段的目的是设计 这样的应用程序，评估其对临床使用的可行性和接受，并获得试点数据以实现确定性 在第二阶段测试假设的益处。 特定的目标1沿着专利申请的个性化舒适谈话应用程序的设计和开发 算法允许沿风格偏好的位置（家庭，候诊室，程序套件），允许个性化的算法， 特定情况的建议和时间可用。经时调整的片段将与指示合并 放松，特定情况图像，疼痛和焦虑管理，可选内容以及 重新定位以无缝调整到4分钟至2小时之间的时间。使用行为的敏捷方法 - 驱动发展（BDD）将用于设计和实施研究表明的功能 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 通过接受测试驱动的计划执行持续的质量控制。 AIM 2是执行试验审判 塔夫茨大学牙科医学院的颅面疼痛中心。六十名患者将随机听 到诊所中的应用程序（n = 30），白噪声（n = 15）或音乐（n = 15），并在应用程序上接收下载优惠券 释放。焦虑和疼痛将对先前验证的量表进行评估（完全不焦虑/无疼痛， 在诊所和在家中出院后7天，可能是10次焦虑/疼痛。过程数据， 药物使用情况，处方，处方呼叫回电话以及对治疗的满意度，该应用将是 记录。 AIM 3将评估临床应用程序使用和试验设计的可行性的接受。应用程序 将通过背景捕获以电子方式建立诊所的使用模式和接受 病人的反馈。应用程序邮政程序的上诉将通过下载优惠券的百分比进行评估 在每个组中使用，合并匿名应用程序数据，并有兴趣在返回访问时使用该应用程序。 患者愿意参加并遵守试验试验的相对因素 确定关键2期试验的可行性和辅助评估措施的选择。