AnesthesiaPhase 4VERITASNCT06333938
Veterans Enhanced Recovery Using Integrative Treatments Around Surgery
A Phase 4 study testing Nonpharmacologic Treatment in people with Anesthesia and Surgery, run by Durham VA Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anesthesia, Surgery, Knee Arthropathy
- What is being tested?
- Nonpharmacologic Treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2025to Jun 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Veterans Scheduled to undergo procedures at the Durham VA
Who cannot join
- Hearing Loss
- Procedures on the Ear
- Risk of Bleeding
- Anosmia
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Karthik Raghunathan, MD MPH contact
United States1 site
Durham Veterans Affairs Medical Center
Durham, North Carolina, 27705
Karthik Raghunathan, MD, MPH, 919-286-6938, Karthik.Raghunathan@va.gov
About this study
Official title: An Effectiveness-Implementation Hybrid Study on the Use of Integrative Treatments for Perioperative Symptom Management.
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.
Read the detailed description
There is an urgent need for effective, safe, and low-cost nonpharmacologic treatments for postoperative pain. This study aims to:
- assess the implementation of Music Medicine, Aromatherapy, and Battlefield Acupuncture among patients presenting for procedures at the Durham Veterans Affairs Medical Center; and,
- 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
- Anesthesia, Surgery, Knee Arthropathy
- Being tested
- Nonpharmacologic Treatment, Standard Care
- Keywords
- Perioperative Care, Complementary Integrative Health (CIH), Battlefield Acupuncture (BFA), Music Medicine, Aromatherapy, Veterans, Integrative Treatments
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nonpharmacologic TreatmentOther
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 CareOther
Patients will receive standard clinical care without the addition of Music Medicine, Aromatherapy, or Battlefield Acupuncture
| Study group | Role | What they receive |
|---|---|---|
| Integrative Treatment | Active comparator | 200 participants will receive at least one of three integrative treatments: Music Medicine, Aromatherapy, Battlefield Acupuncture Receives: Other: Nonpharmacologic Treatment |
| Standard Care | Active comparator | 200 patients will not receive standard care without any additional integrative treatments Receives: Other: Standard Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
The amount of opioid analgesic medications received by patients as recorded in the electronic health record (inpatient setting) or as reported by patients (outpatient setting) will be summarized each day and reported in daily oral morphine equivalents. The total amount from postoperative day 0 to day 5, and the average daily oral morphine equivalents will be measured for comparisons. Higher amounts represent worse outcomes.
Measured: Each day from Postoperative Day 0 to Day 5.
Quality of Recovery among patients as measured using the Quality-of-Recovery 40 tool.
The Quality-of-Recovery 40 tool is a 40-item questionnaire, with each question graded on a five-point Likert scale. Scores range from 40 (extremely poor quality of recovery) to 200 (excellent quality of recovery). Assessment will occur preoperatively on the day of surgery (baseline value) and each day from Postoperative Day 0 to 5. The difference between the baseline and the value each day will be compared.
Measured: Preoperative on the day of surgery, and each day from Postoperative Day 0 to Day 5.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2024
- Study startSep 2025 (estimated)
- Primary completionSep 2026 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Durham VA Medical Center
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06333938
- Sponsor's protocol ID
- 01968
- Acronym
- VERITAS
- Status last verified
- Apr 2025
- First submitted
- 13 Dec 2023
- Last updated
- 1 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Effectiveness-Implementation Hybrid Study on the Use of Integrative Treatments for Perioperative Symptom Management.
- ClinicalTrials.gov ID
- NCT06333938
- Acronym / sponsor ID
- VERITAS / 01968
- Conditions
- Anesthesia, Surgery, Knee Arthropathy
- Keywords
- Perioperative Care, Complementary Integrative Health (CIH), Battlefield Acupuncture (BFA), Music Medicine, Aromatherapy, Veterans, Integrative Treatments
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Durham VA Medical CenterUS federal agency
- Study start
- Sep 2025 (estimated)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 27 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- assess the implementation of Music Medicine, Aromatherapy, and Battlefield Acupuncture among patients presenting for procedures at the Durham Veterans Affairs Medical Center; and,
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Integrative Treatment | Active comparator | Other: Nonpharmacologic Treatment200 participants will receive at least one of three integrative treatments: Music Medicine, Aromatherapy, Battlefield Acupuncture |
| Standard Care | Active comparator | Other: Standard Care200 patients will not receive standard care without any additional integrative treatments |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Veterans Scheduled to undergo procedures at the Durham VA
Key exclusion criteria (4 listed)
- Hearing Loss
- Procedures on the Ear
- Risk of Bleeding
- Anosmia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nonpharmacologic TreatmentAt 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. | Other | Integrative Treatment |
| Standard CarePatients will receive standard clinical care without the addition of Music Medicine, Aromatherapy, or Battlefield Acupuncture | Other | Standard Care |
Primary outcome
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.
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.
Time frame: 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.
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.
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 Checklist
Time frame: Each 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.
Time frame: 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 Checklist
Time frame: On 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.
2 secondary outcomes
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Karthik Raghunathan, MD MPH contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Nonpharmacologic Treatment in people with Anesthesia and Surgery, run by Durham VA Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 1 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Karthik Raghunathan, MD MPH (2158507220, karthik.raghunathan@duke.edu; Karthik.Raghunathan@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2025; AzTrials last refreshed its copy on 6 Nov 2026.