Veterans Enhanced Recovery Using Integrative Treatments Around Surgery

NCT06333938 | Not Yet Recruiting Phase 4

• 1 other identifier: 01968
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Anesthesia; Surgery; Knee Arthropathy

Keywords

Perioperative Care; Complementary Integrative Health (CIH); Battlefield Acupuncture (BFA); Music Medicine; Aromatherapy; Veterans; Integrative Treatments

Outcome Measures

Primary Outcomes (6)

• Pain and Pain Interference assessed among patients using the Defense veterans pain rating scale 2.0

  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.

  Each day from Postoperative Day 0 to Day 5.

• Heart Rate Variability among Patients as assessed using time and frequency domain analysis of the heart rate.

  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.

  Each day (over 8-hour periods, 7pm and 7am) from 5 days before surgery to postoperative day 5.

• Implementation of Treatment among Patients as assessed by the Acceptability of Intervention, Appropriateness of Intervention, and Feasibility of Intervention Measures.

  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.

  Measurement will be at three points: within the 5 day period before surgery; on the day of Surgery; and on postoperative day 5.

• Fidelity of Treatment among Patients as assessed by a Fidelity Checklist

  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.

  Each day from Postoperative Day 0 to Day 5.

• Implementation of Treatment among Providers as assessed by the Acceptability of Intervention, Appropriateness of Intervention, and Feasibility of Intervention Measures.

  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.

  On the day of surgery or within 1-day after.

• Fidelity of Treatment among Providers as assessed by a Fidelity Checklist

  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.

  On the day of surgery or within 1-day after.

Secondary Outcomes (2)

• Amount of Opioid medication received by patients assessed in average daily oral morphine equivalents.

  Each day from Postoperative Day 0 to Day 5.

• 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.

Study Arms (2)

Integrative Treatment

ACTIVE COMPARATOR

200 participants will receive at least one of three integrative treatments: Music Medicine, Aromatherapy, Battlefield Acupuncture

Other: Nonpharmacologic Treatment

Standard Care

ACTIVE COMPARATOR

200 patients will not receive standard care without any additional integrative treatments

Other: Standard Care

Interventions

Nonpharmacologic Treatment OTHER

At least one three nonpharmacologic treatments (Music Medicine, Aromatherapy, Battlefield Acupuncture) will be delivered. Music Medicine is the delivery of personal music players to listen to patient-preferred music before, during, or after surgical or non-surgical procedures. Aromatherapy is the delivery of personally-preferred AromaTabs before, during, or after surgical or non-surgical procedures. Battlefield Acupuncture is the delivery of Auricular Acutherapy by trained providers using acupuncture needles or acupressure beads before, during, or after surgical or non-surgical procedures.

Integrative Treatment

Standard Care OTHER

Patients will receive standard clinical care without the addition of Music Medicine, Aromatherapy, or Battlefield Acupuncture

Standard Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Veterans Scheduled to undergo procedures at the Durham VA

You may not qualify if:

• Hearing Loss
• Procedures on the Ear
• Risk of Bleeding
• Anosmia

Sponsors & Collaborators

• Durham VA Medical Center: lead

Study Sites (1)

Durham Veterans Affairs Medical Center

Durham, North Carolina, 27705, United States

Location

MeSH Terms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Central Study Contacts

Karthik Raghunathan, MD MPH

CONTACT

2158507220; karthik.raghunathan@duke.edu; Karthik.Raghunathan@va.gov

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2023
• First Posted: March 27, 2024
• Study Start: September 1, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: May 1, 2025

Record last verified: 2025-04

Locations

US (1)