Veterans Enhanced Recovery Using Integrative Treatments Around Surgery
{ "Veterans Enhanced Recovery Using Integrative Treatments Around Surgery", "This study, called \"Veterans Enhanced Recovery Using Integrative Treatments Around Surgery,\" is looking at ways to help Veterans manage pain and anxiety around surgery without relying solely on medications. It's testing three non-drug treatments: Music Medicine (listening to preferred music), Aromatherapy, and Battlefield Acupuncture. The study wants to see how well these treatments work, alone or together, compared to standard care for Veterans having procedures at the Durham VA. Researchers will measure your pain levels and heart rate, and also check how easy it is to use these treatments. You might be able to join if you are a Veteran aged 18 or older, scheduled for a procedure at the Durham VA, and do not have certain conditions like hearing loss or a risk of bleeding. The study aims to enroll 400 Veterans.", "design": "This study will involve 400 Veterans. Participants will either receive one of the integrative treatments or standard care, with treatments offered on alternate months.", "commitments": "You will have your pain and heart rate measured daily from before surgery until 5 days after. You will also be asked about your experience with the treatments before surgery, on the day of surgery, and 5 days after.", "compensation": "Not stated in the trial record.", "follow_up": "Your pain and heart rate will be monitored daily from 5 days before surgery until 5 days after surgery. Your experience with the treatments will be assessed up to 5 days after surgery.", }
- Study design
- Not specified.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Not specified.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Veterans Enhanced Recovery Using Integrative Treatments Around Surgery
At a glance
Conditions
Where it's being run
1 sites across 1 statesWho to contact
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What this trial measures
- Pain and Pain Interference assessed among patients using the Defense veterans pain rating scale 2.0Each 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.
- 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.
- Fidelity of Treatment among Patients as assessed by a Fidelity ChecklistEach 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 ChecklistOn 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.