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Not yet recruiting NCT06333938

Veterans Enhanced Recovery Using Integrative Treatments Around Surgery

Phase IV Interventional Anesthesia Surgery Knee Arthropathy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Nonpharmacologic Treatment, Standard Care.
Who it may be relevant to
Registry conditions: Anesthesia, Surgery, Knee Arthropathy. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

An Effectiveness-Implementation Hybrid Study on the Use of Integrative Treatments for Perioperative Symptom Management.

Overview

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.

Interventions

  • Other Nonpharmacologic Treatment
    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 acupun
  • Other Standard Care
    Patients will receive standard clinical care without the addition of Music Medicine, Aromatherapy, or Battlefield Acupuncture

Primary outcome measures

  • Pain and Pain Interference assessed among patients using the Defense veterans pain rating scale 2.0 [Time frame: 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. [Time frame: 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. [Time frame: 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 [Time frame: 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. [Time frame: On the day of surgery or within 1-day after.]
  • Fidelity of Treatment among Providers as assessed by a Fidelity Checklist [Time frame: On the day of surgery or within 1-day after.]
Secondary outcome measures (2)
  • Amount of Opioid medication received by patients assessed in average daily oral morphine equivalents. [Time frame: Each day from Postoperative Day 0 to Day 5.]
  • Quality of Recovery among patients as measured using the Quality-of-Recovery 40 tool. [Time frame: Preoperative on the day of surgery, and each day from Postoperative Day 0 to Day 5.]

Eligibility criteria

Inclusion criteria

  • Veterans Scheduled to undergo procedures at the Durham VA

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • Durham Veterans Affairs Medical Center — Durham

Identifiers

NCT: NCT06333938 · 01968

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗