Nonpharmacologic Reduction of Periprocedural Pain, Anxiety, and Prescription Drug Use Phase II
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Anxiety during the dental visit (Change as Compared to Beginning of the Waiting Room Time)
研究概览
简要总结
Dental pain and anxiety are usually managed by local anesthetics and sedatives, but patient anxiety and fear of pain remain common and adversely affect oral health behavior and outcomes. The long-term goal is to provide a validated behavioral alternative/adjunct for managing dental anxiety and pain through a commercial Comfort Talk® (Cft) app. Such an application should benefit the patients undergoing the >300 million dental procedures per year in the US alone. In Phase I (Clinical Trials Identifier NCT03328208), the investigators designed such an app based on short Comfort Talk® scripts and snippets that, when spoken live by trained personnel in our prior large-scale clinical trials, reduced pain, anxiety, and drug use during invasive procedures, and when used practice-wide, improved patient attendance, throughput, and economics. In Phase I, the Cft app significantly reduced pain and anxiety in the dental waiting room. In Phase II, the investigators propose to further assess its impact.
We hypothesize that:
- The Cft app reduces pain and anxiety in the waiting room
- The Cft app improves the patient experience and cooperation during dental treatment
- The Cft app improves operations and economics of dental practices
- Heart rate tracings are helpful in identifying outcome-critical app elements
150 patients scheduled for root canals or dental implants will receive in randomized sequence the Cft app or a placebo white noise app in the dentistry waiting room of Cambridge Health Alliance. Anxiety and pain will be measured subjectively on validated scales (0-no anxiety/no pain at all; 10-worst anxiety/pain possible) before listening and throughout the visit. Heart rate (HR) and ECG will be continuously recorded to assess adverse events and, in the absence of a validated biomarker for pain and anxiety, serve as an exploratory physiologic indicator of distress. Usage patterns of the Cft and the placebo apps will be established electronically through time-stamped background capture, de-identified, and uploaded to a database along with the corresponding HR recordings and overlayed with the patient's subjective ratings and procedure steps to identify outcome-critical elements of the app.
We will record chair-time, staff-time, use of anesthetics and sedatives, if applicable, and patient and staff satisfaction, supplemented by bulk data acquired from other practices that use a co-branded version of the app, to determine the economic impact of the Cft app.
详细描述
Dental pain and anxiety are usually managed by local anesthetics and sedatives, but patient anxiety and fear of pain remain common and adversely affect oral health behavior and outcomes. The long-term goal is to provide a validated behavioral alternative/adjunct for managing dental anxiety and pain through a commercial Comfort Talk® (Cft) app. Such an application should benefit the patients undergoing the >300 million dental procedures per year in the US alone. In Phase I (Clinical Trials Identifier NCT03328208), the investigators designed such an app based on short Comfort Talk® scripts and snippets that, when spoken live by trained personnel in their prior large-scale clinical trials, reduced pain, anxiety, and drug use during invasive procedures, and when used practice-wide, improved patient attendance, throughput, and economics. In Phase I, the Cft app significantly reduced pain and anxiety in the dental waiting room. In Phase II, the investigators propose to further assess its impact. In Phase II, the investigators propose to further assess the impact of the Cft app in dentistry in accordance with an objective of the National Center for Complementary and Integrative Health(NCCIH) 2021-2025 Strategic Plan: testing the integration of a complementary approach into healthcare in a real-world setting.
The hypotheses are:
- The Cft app reduces pain and anxiety in the waiting room
- The Cft app improves the patient experience and cooperation during dental treatment
- The Cft app improves operations and economics of dental practices
- Heart rate tracings are helpful in identifying outcome-critical app elements
150 patients scheduled for root canals or dental implants will receive in randomized sequence the Cft app or a placebo white noise app in the dentistry waiting room.
The trial will be performed at Cambridge Health Alliance (CHA), Department of Dental Medicine, based on their high patient volume (>12,000 annual visits) and ethnically/racially diverse mix of patients. CHA is a nationally respected and innovative healthcare system and Massachusetts' largest safety net organization. CHA is committed to providing care for the undeserved and promoting interprofessional/cross-disciplinary care for all regardless of cultural, racial, or socioeconomic background. All patients of the dental clinic also receive their primary care through CHA, enabling electronic chart review regarding prior dental experiences, vital signs, and medical history.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Care Provider, Investigator, Outcomes Assessor)
盲法说明
Two iPad tablets used in the study will be labeled A and B and will be preloaded with the app or white noise by the Hypnalgesics, LLC in randomized sequence. Personnel at CHA will not be aware which tablet presents test or control content. The opening screen and option screen of the white noise control app will use the same color scheme and lay-out as the one of the test Comfort Talk app. The statistical team will receive the encoded data entries and will not be informed about the content of the tablets until all analyses are completed. Since they also will not have direct contact with the study patients they are also not at risk of becoming unblinded during app use by the patients
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Scheduled to undergo a root canal or dental implant procedure at Cambridge - Health Alliance
- •Able to hear, write and read in English, as the ComfortTalk® scripts, study scales and take-home diary are in English
- •Able to operate a standard smart tablet
- •Willing and able to give informed consent
排除标准
- •Known acute psychiatric disorder, such as multiple personalities which will be assessed on the medical history form
- •Implanted cardiac medical device
- •Not meeting inclusion criteria
结局指标
主要结局
Anxiety during the dental visit (Change as Compared to Beginning of the Waiting Room Time)
时间窗: Up to 180 minutes
Anxiety as measured by self-report on a 0-10 scale with 0=no anxiety at all and 10=worst anxiety possible; change from the beginning to the end of the waiting room time, measured before listening to the app, at the end of the waiting room, every 10 minutes on the dental chair, and after treatment completion
Pain during the dental visit (Change as Compared to Beginning of the Waiting Room Time)
时间窗: Up to 180 minutes
Pain as measured by self-report on a 0-10 scale with 0=no pain at all and 10=worst pain possible; change from the beginning to the end of the waiting room time, measured before listening to the app, at the end of the waiting room, every 10 minutes on the dental chair, and after treatment completion
次要结局
- Chair Time(Up to 180 minutes)
- Staff Satisfaction(10 minutes)
- Staff Time(Up to 180 minutes)
- Adverse events(Up to 180 minutes)
- Patient Satisfaction(10 minutes)