Veterans Enhanced Recovery Using Integrative Treatments Around Surgery

NCT ID: NCT06333938

Last Updated: 2025-05-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-30

Study Completion Date

2027-06-30

Brief Summary

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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

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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.

Conditions

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Anesthesia Surgery Knee Arthropathy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Integrative Treatment

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

Group Type ACTIVE_COMPARATOR

Nonpharmacologic Treatment

Intervention Type 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.

Standard Care

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

Group Type ACTIVE_COMPARATOR

Standard Care

Intervention Type OTHER

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

Interventions

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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 acupuncture needles or acupressure beads before, during, or after surgical or non-surgical procedures.

Intervention Type OTHER

Standard Care

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Veterans Scheduled to undergo procedures at the Durham VA

Exclusion Criteria

* Hearing Loss
* Procedures on the Ear
* Risk of Bleeding
* Anosmia
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Durham VA Medical Center

FED

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Durham Veterans Affairs Medical Center

Durham, North Carolina, United States

Site Status

Countries

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United States

Central Contacts

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Karthik Raghunathan, MD MPH

Role: CONTACT

Facility Contacts

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Karthik Raghunathan, MD, MPH

Role: primary

919-286-6938

Other Identifiers

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01968

Identifier Type: -

Identifier Source: org_study_id

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