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.
Current pain management in conjunction with the annual >100 million surgical and >300 million dental procedures in US is ineffective and contributes to the annual 28,000 overdose death from prescription-drugs. The Comfort Talk app project seeks to begin pain management upfront at first contact with the patient. The goal is to empower the patient with coping skills to reduce pain, anxiety, and need for opioids before addiction occurs.
