Clinical trial NCT06333938: Veterans Enhanced Recovery Using Integrative Treatments Around Surgery
Official title: An Effectiveness-Implementation Hybrid Study on the Use of Integrative Treatments for Perioperative Symptom Management.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Anesthesia
Surgery
Knee Arthropathy
Keywords: Perioperative Care
Complementary Integrative Health (CIH)
Battlefield Acupuncture (BFA)
Music Medicine
Aromatherapy
Veterans
Integrative Treatments
Lead sponsor: Durham VA Medical Center
Sponsor class: FED
First posted: 2024-03-27
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Pain and Pain Interference assessed among patients using the Defense veterans pain rating scale 2.0
timeFrame: Each day from Postoperative Day 0 to Day 5.
measure: Heart Rate Variability among Patients as assessed using time and frequency domain analysis of the heart rate.
timeFrame: Each day (over 8-hour periods, 7pm and 7am) from 5 days before surgery to postoperative day 5.
measure: Implementation of Treatment among Patients as assessed by the Acceptability of Intervention, Appropriateness of Intervention, and Feasibility of Intervention Measures.
timeFrame: Measurement will be at three points: within the 5 day period before surgery; on the day of Surgery; and on postoperative day 5.
measure: Fidelity of Treatment among Patients as assessed by a Fidelity Checklist
timeFrame: Each day from Postoperative Day 0 to Day 5.
measure: Implementation of Treatment among Providers as assessed by the Acceptability of Intervention, Appropriateness of Intervention, and Feasibility of Intervention Measures.
timeFrame: On the day of surgery or within 1-day after.
measure: Fidelity of Treatment among Providers as assessed by a Fidelity Checklist
timeFrame: On the day of surgery or within 1-day after.
Secondary outcomes:
measure: Amount of Opioid medication received by patients assessed in average daily oral morphine equivalents.
timeFrame: Each day from Postoperative Day 0 to Day 5.
measure: Quality of Recovery among patients as measured using the Quality-of-Recovery 40 tool.
timeFrame: Preoperative on the day of surgery, and each day from Postoperative Day 0 to Day 5.
Other outcomes:
Locations:
city: Durham
country: United States
facility: Durham Veterans Affairs Medical Center
state: North Carolina
Study officials:
References: