Veterans Enhanced Recovery Using Integrative Treatments Around Surgery
- Conditions
- AnesthesiaSurgeryKnee Arthropathy
- Interventions
- Device: BFADevice: Bridge
- Registration Number
- NCT06333938
- Lead Sponsor
- Durham VA Medical Center
- Brief Summary
The study aims to assess the implementation and effectiveness of Integrative Treatments - Music Medicine, Aromatherapy, and Battlefield Acupuncture - in the management of perioperative pain and anxiety, and in the reduction of related pharmacologic treatments.
- Detailed Description
There is an urgent need for effective, safe, and low-cost nonpharmacologic treatments for postoperative pain. This study aims to:
1. assess the implementation of Music Medicine, Aromatherapy, and Battlefield Acupuncture among patients presenting for procedures at the Durham Veterans Affairs Medical Center; and,
2. compare the effectiveness of these treatments, alone and in combination, versus standard clinical practice not involving any of these treatments.
Patients from the Durham Veterans Affairs Medical Center (Durham VAMC) scheduled to undergo procedures will be eligible to participate in this study. A sample of 400 veterans will be studied. We will offer treatments versus no treatment on alternate months. Recruitment will end when 200 patients have received at least one of these treatments, and 200 patients have received no treatment.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 400
- Veterans Scheduled to undergo procedures at the Durham VA
- Hearing Loss
- Procedures on the Ear
- Risk of Bleeding
- Anosmia
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Battlefield Acupuncture (BFA) BFA 30 participants will receive BFA, up to 10 patients per month Bridge Bridge Experimental - 30 participants will receive the Bridge device, up to 10 patients per month
- Primary Outcome Measures
Name Time Method Fidelity of Treatment among Patients as assessed by a Fidelity Checklist Each day from Postoperative Day 0 to Day 5. Fidelity, the degree to which an intervention was implemented as it was intended by the developers, will be measured using a fidelity instrument with three domains: adherence (adherence to each component of treatment, scale 1- 5), participant responsiveness (measured on the treatment expectation questionnaire scale 0-10), and dosage (scale 1-5). Higher scores are better. We will compare the average scores overall, and in each domain.
Implementation of Treatment among Providers as assessed by the Acceptability of Intervention, Appropriateness of Intervention, and Feasibility of Intervention Measures. On the day of surgery or within 1-day after. The Acceptability of Intervention measure, Appropriateness of Intervention measure, and Feasibility of Intervention Measure will be used. Each of these three tools is a 4-item questionnaire that has been validated as a distinct and strong measure of implementation success. Scale values for each measure range from 1-5. The average of the three measures will be computed and compared. Higher scores represent better outcomes.
Fidelity of Treatment among Providers as assessed by a Fidelity Checklist On the day of surgery or within 1-day after. Fidelity, the degree to which an intervention was implemented as it was intended by the developers, will be measured using a fidelity instrument with two domains: adherence (adherence to each component of treatment, scale 1- 5), and participant responsiveness (measured on the treatment expectation questionnaire scale 0-10). Higher scores are better. We will compare the average scores overall, and in each domain.
Implementation of Treatment among Patients as assessed by the Acceptability of Intervention, Appropriateness of Intervention, and Feasibility of Intervention Measures. Measurement will be at three points: within the 5 day period before surgery; on the day of Surgery; and on postoperative day 5. The Acceptability of Intervention measure, Appropriateness of Intervention measure, and Feasibility of Intervention Measure will be used. Each of these three tools is a 4-item questionnaire that has been validated as a distinct and strong measure of implementation success. Scale values for each measure range from 1-5. The average of the three measures will be computed and compared at each time point. Higher scores represent better outcomes.
Pain and Pain Interference assessed among patients using the Defense veterans pain rating scale 2.0 Each day from Postoperative Day 0 to Day 5. The Defense and Veterans Pain Rating Scale 2.0 utilizes a numerical rating scale enhanced by functional word descriptors, color coding, and pictorial facial expressions matched to pain levels. Four supplemental questions measure how much pain: a) interferes with usual activity, b) interferes with sleep, c) affects mood and d) contributes to stress. The scale for each assessment ranges from 0-10. Three assessments will occur each day. The daily average values will be compared at each time point. Higher Scores represent worse outcomes.
Heart Rate Variability among Patients as assessed using time and frequency domain analysis of the heart rate. Each day (over 8-hour periods, 7pm and 7am) from 5 days before surgery to postoperative day 5. Heart rate variability represents the change in the time interval in milliseconds between successive heartbeats. It is a measure of input to the heart from both sympathetic and parasympathetic branches of the nervous system. Increased heart rate variability is the better outcome.
- Secondary Outcome Measures
Name Time Method Amount of Opioid medication received by patients assessed in average daily oral morphine equivalents. Each day from Postoperative Day 0 to Day 5. The amount of opioid analgesic medications received by patients as recorded in the electronic health record (inpatient setting) or as reported by patients (outpatient setting) will be summarized each day and reported in daily oral morphine equivalents. The total amount from postoperative day 0 to day 5, and the average daily oral morphine equivalents will be measured for comparisons. Higher amounts represent worse outcomes.
Quality of Recovery among patients as measured using the Quality-of-Recovery 40 tool. Preoperative on the day of surgery, and each day from Postoperative Day 0 to Day 5. The Quality-of-Recovery 40 tool is a 40-item questionnaire, with each question graded on a five-point Likert scale. Scores range from 40 (extremely poor quality of recovery) to 200 (excellent quality of recovery). Assessment will occur preoperatively on the day of surgery (baseline value) and each day from Postoperative Day 0 to 5. The difference between the baseline and the value each day will be compared.
Trial Locations
- Locations (1)
Durham Veterans Affairs Medical Center
🇺🇸Durham, North Carolina, United States