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The purpose of pilot study is to test the feasibility of nurse initiated post-operative bilateral auricular acupressure as an adjunct to medication for post-operative pain management.
Postoperative pain management has become an area of concern over the last decade due to the opioid epidemic and concerns related to their use as the primary pain management strategy. Joint Commission requires that hospitals have additional pain non-pharmacologic pain management tools at their disposal to an effort decrease the reliance on opioids. Acupuncture and acupressure have been used for centuries in the management of a variety of disorders including pain. Unlike acupuncture, acupressure can be easily applied with limited training and is within the scope of practice for nurses, according to the North Carolina Board of Nursing. Thus evidence based non-pharmacologic strategies that can be deployed by nursing are of benefit to hospital organizations.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Auricular acupressure Group | Experimental | The Auricular acupressure (AA) nurses will place the acupressure pellet pads on the participants in this group post-operatively. |
|
| Standard of care Group | Active Comparator | Participants in this group will receive standard of care pain management by the treating physician. |
|
| Nurse Interventionists | No Intervention | Nurses who were trained to apply the auricular acupressure pads/pellets in the the holding room prior to surgery. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Auricular acupressure | Device | Trained nurses in auricular acupressure will place acupressure beads on 5 acupoints on each ear (cingulate gyrus, thalamus, omega-2, point zero, and Shen Men). The nurse will do the initial activation of the acupressure site by applying pressure for 30 seconds to each point until the participant reports tingling or moderate degree of pressure. Participant will be given instructions to do this three times a day for a total of 5 days. Acupoints were selected based on recommendation of faculty acupuncturist. |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analogue Pain Scale | Average "pain upon awakening" score from 0 to 10 using visual analogue scale (0= no pain, 10= worst pain). Pain score averaged across post-op days 1 - 4. | Up to Post-operatively day 4, at rising approximately 6 am |
| Visual Analogue Pain Scale | Average "pain before bed" score from 0 to 10 using visual analogue scale (0= no pain, 10= worst pain).Pain score averaged across post-op days 0 - 4. | Up to Post-operatively day 4, at the end of the day approximately 10 pm |
| Medication Use - Outpatient Opioids | Amount of medication use after discharge recorded in total morphine equivalent dose from discharge through day 4 postoperatively | Up to post-operatively day 4 |
| Medication Use - Inpatient Opioids | Amount of medication recorded in morphine equivalent dose while in hospital (not including anesthesia) | Up to post-operatively day 4 |
| Medication Use - Total Other Analgesics | Amount of of other analgesics other than aspirin and not part of anesthesia record from immediate post-operative period to day 4 post-op in reported milligrams. | Up to post-operatively day 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analogue Pain Scale | Average "pain upon awakening" score from 0 to 10 using visual analogue scale (0= no pain, 10= worst pain). | Baseline |
| Visual Analogue Pain Scale | Average "pain upon awakening" score from 0 to 10 using visual analogue scale (0= no pain, 10= worst pain). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carolyn S Huffman, WHNP, PhD | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Davie Medical Center | Bermuda Run | North Carolina | 27006 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Auricular Acupressure Group | The Auricular acupressure (AA) nurses will place the acupressure pellet pads on the participant post-operatively. Auricular acupressure: Trained nurses in auricular acupressure will place acupressure beads on 5 acupoints on each ear (cingulate gyrus, thalamus, omega-2, point zero, and Shen Men). The nurse will do the initial activation of the acupressure site by applying pressure for 30 seconds to each point until the participant reports tingling or moderate degree of pressure. Participant will be given instructions to do this three times a day for a total of 5 days. Acupoints were selected based on recommendation of faculty acupuncturist. Standard of care pain management: The participant post-operative pain will be managed following the standard protocol by the treating physician. |
| FG001 | Standard of Care Group | Standard of care pain management: The participant post-operative pain will be managed following the standard protocol by the treating physician. |
| FG002 | Nurse Interventionists | Nurses who were trained to apply the auricular acupressure pads/pellets in the the holding room prior to surgery. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
No baseline demographic information was gathered on participants in the Nurses arm, so those participants are not included in this section.
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| ID | Title | Description |
|---|---|---|
| BG000 | Auricular Acupressure Group | The Auricular acupressure (AA) nurses will place the acupressure pellet pads on the participant post-operatively. Auricular acupressure: Trained nurses in auricular acupressure will place acupressure beads on 5 acupoints on each ear (cingulate gyrus, thalamus, omega-2, point zero, and Shen Men). The nurse will do the initial activation of the acupressure site by applying pressure for 30 seconds to each point until the participant reports tingling or moderate degree of pressure. Participant will be given instructions to do this three times a day for a total of 5 days. Acupoints were selected based on recommendation of faculty acupuncturist. Standard of care pain management: The participant post-operative pain will be managed following the standard protocol by the treating physician. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Visual Analogue Pain Scale | Average "pain upon awakening" score from 0 to 10 using visual analogue scale (0= no pain, 10= worst pain). Pain score averaged across post-op days 1 - 4. | 1 in Treatment and 2 in Standard of Care (SOC) group with incomplete missing data. | Posted | Mean | Standard Deviation | units on a scale | Up to Post-operatively day 4, at rising approximately 6 am |
|
Adverse events collected from post-operative day 0 - post-operative day 5
self reported on daily study questionnaire; no adverse event information gathered for Nurse Interventionist arm
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Auricular Acupressure Group | The Auricular acupressure (AA) nurses will place the acupressure pellet pads on the participant post-operatively. Auricular acupressure: Trained nurses in auricular acupressure will place acupressure beads on 5 acupoints on each ear (cingulate gyrus, thalamus, omega-2, point zero, and Shen Men). The nurse will do the initial activation of the acupressure site by applying pressure for 30 seconds to each point until the participant reports tingling or moderate degree of pressure. Participant will be given instructions to do this three times a day for a total of 5 days. Acupoints were selected based on recommendation of faculty acupuncturist. Standard of care pain management: The participant post-operative pain will be managed following the standard protocol by the treating physician. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Irritation at auricular acupressure site | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Carolyn Huffman | Atrium Health Wake Forest Baptist | 336.713.4018 | cshuffma@wakehealth.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 19, 2020 | Sep 9, 2022 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 1, 2021 | Oct 26, 2021 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D059787 | Acute Pain |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D019050 | Acupressure |
| ID | Term |
|---|---|
| D064746 | Therapy, Soft Tissue |
| D026201 | Musculoskeletal Manipulations |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
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Arm 1 Treatment group, Arm 2 Control group, Arm 3 Nurse Interventionist group
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Statistician blinded to study arms during analysis phase.
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| Standard of care pain management | Other | The participant post-operative pain will be managed following the standard protocol by the treating physician. |
|
| post-operatively day 1, at rising |
| Visual Analogue Pain Scale | Total score 0 to 10 on visual analogue scale, anchors 0=no pain, 10 equals worse pain. | post-operatively day 2, at rising |
| Visual Analogue Pain Scale | Average "pain upon awakening" score from 0 to 10 using visual analogue scale (0= no pain, 10= worst pain). | post-operatively day 3, at rising |
| Visual Analogue Pain Scale | Average "pain upon awakening" score from 0 to 10 using visual analogue scale (0= no pain, 10= worst pain). | post-operatively day 4, at rising |
| Visual Analogue Pain Scale | Average "pain upon awakening" score from 0 to 10 using visual analogue scale (0= no pain, 10= worst pain). | post-operatively day 1, at the end of the day |
| Visual Analogue Pain Scale | Average "pain upon awakening" score from 0 to 10 using visual analogue scale (0= no pain, 10= worst pain). | post-operatively day 2, at the end of the day |
| Visual Analogue Pain Scale | Average "pain upon awakening" score from 0 to 10 using visual analogue scale (0= no pain, 10= worst pain). | post-operatively day 3, at the end of the day |
| Visual Analogue Pain Scale | Average "pain upon awakening" score from 0 to 10 using visual analogue scale (0= no pain, 10= worst pain). | post-operatively day 4, at the end of the day |
| Mean Number of Pellets Retained | Mean number of pellets retained on post-operative day 4. This Outcome Measure was pre-specified to be assessed for the "Auricular Acupressure Group" Arm only. | Up to post-operatively day 4 |
| Number of Participants Who Responded They Were Satisfied With Pain Management | Likert scale with a total score of 0 to 6--higher scores denotes worse outcomes. Force choice: very satisfied, satisfied, somewhat satisfied, somewhat dissatisfied, dissatisfied, very dissatisfied. Any degree of satisfaction compared to any degree of dissatisfaction. Satisfied included responses very satisfied to somewhat satisfied | post-operatively day 4 |
| Number of Participants Who Responded "Yes, Would Definitely Consider Using in the Future." | Participants were asked if they "would consider using auricular acupressure in the future for pain if recommended by a nurse or physician?" Possible answers are "no, would not use again", "maybe", or "Yes, would definitely consider using in the future." | post-operatively day 4 |
| Nurse Time to Deploy Pellets | Reported as the number of minutes that it took nurse interventionists to place acupressure seeds (pellets), activate, and provide instruction. | post-operatively day 5 |
| Number of Nurse Concerns Reported | Review nurse reports in encounters. Count number of concerns pooled across all participants in encounters with disruption of workflow due to care unit or patient barriers documented while participant was in hospital. Concerns included workflow and patient barriers. This outcome applies to nurse interventionists arm only. | post-operatively day 0 and 1 |
| BG001 | Standard of Care Group | Standard of care pain management: The participant post-operative pain will be managed following the standard protocol by the treating physician. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| OG001 | Standard of Care Group | Standard of care pain management: The participant post-operative pain will be managed following the standard protocol by the treating physician. |
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| Primary | Visual Analogue Pain Scale | Average "pain before bed" score from 0 to 10 using visual analogue scale (0= no pain, 10= worst pain).Pain score averaged across post-op days 0 - 4. | 3 in Treatment group and 3 in Standard of Care (SOC) group with missing data. | Posted | Mean | Standard Deviation | units on a scale | Up to Post-operatively day 4, at the end of the day approximately 10 pm |
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| Primary | Medication Use - Outpatient Opioids | Amount of medication use after discharge recorded in total morphine equivalent dose from discharge through day 4 postoperatively | 1 in Treatment group and 1 in Standard of Care (SOC) group with missing data. | Posted | Mean | Standard Deviation | morphine milligram equivalents | Up to post-operatively day 4 |
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| Primary | Medication Use - Inpatient Opioids | Amount of medication recorded in morphine equivalent dose while in hospital (not including anesthesia) | Data obtained from hospital medication administration record on all participants. | Posted | Mean | Standard Deviation | MME | Up to post-operatively day 4 |
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| Primary | Medication Use - Total Other Analgesics | Amount of of other analgesics other than aspirin and not part of anesthesia record from immediate post-operative period to day 4 post-op in reported milligrams. | 1 in Treatment group and 3 in Standard of Care (SOC) group with missing data. | Posted | Mean | Standard Deviation | milligrams | Up to post-operatively day 4 |
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| Secondary | Visual Analogue Pain Scale | Average "pain upon awakening" score from 0 to 10 using visual analogue scale (0= no pain, 10= worst pain). | Posted | Mean | Standard Deviation | units on a scale | Baseline |
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| Secondary | Visual Analogue Pain Scale | Average "pain upon awakening" score from 0 to 10 using visual analogue scale (0= no pain, 10= worst pain). | Data from "other" participant in treatment group who stopped study treatment. | Posted | Mean | Standard Deviation | units on a scale | post-operatively day 1, at rising |
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| Secondary | Visual Analogue Pain Scale | Total score 0 to 10 on visual analogue scale, anchors 0=no pain, 10 equals worse pain. | Posted | Mean | Standard Deviation | units on a scale | post-operatively day 2, at rising |
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| Secondary | Visual Analogue Pain Scale | Average "pain upon awakening" score from 0 to 10 using visual analogue scale (0= no pain, 10= worst pain). | 2 in Treatment with missing data. | Posted | Mean | Standard Deviation | units on a scale | post-operatively day 3, at rising |
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| Secondary | Visual Analogue Pain Scale | Average "pain upon awakening" score from 0 to 10 using visual analogue scale (0= no pain, 10= worst pain). | 2 in Treatment and 2 in Standard of Care (SOC) group with missing data. | Posted | Mean | Standard Deviation | units on a scale | post-operatively day 4, at rising |
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| Secondary | Visual Analogue Pain Scale | Average "pain upon awakening" score from 0 to 10 using visual analogue scale (0= no pain, 10= worst pain). | 1 in Standard of Care group with missing data. | Posted | Mean | Standard Deviation | units on a scale | post-operatively day 1, at the end of the day |
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| Secondary | Visual Analogue Pain Scale | Average "pain upon awakening" score from 0 to 10 using visual analogue scale (0= no pain, 10= worst pain). | Posted | Mean | Standard Deviation | units on a scale | post-operatively day 2, at the end of the day |
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| Secondary | Visual Analogue Pain Scale | Average "pain upon awakening" score from 0 to 10 using visual analogue scale (0= no pain, 10= worst pain). | 2 in Treatment with missing data. | Posted | Mean | Standard Deviation | units on a scale | post-operatively day 3, at the end of the day |
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| Secondary | Visual Analogue Pain Scale | Average "pain upon awakening" score from 0 to 10 using visual analogue scale (0= no pain, 10= worst pain). | 3 in Treatment and 3 in Standard of Care (SOC) group with missing data. | Posted | Mean | Standard Deviation | units on a scale | post-operatively day 4, at the end of the day |
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| Secondary | Mean Number of Pellets Retained | Mean number of pellets retained on post-operative day 4. This Outcome Measure was pre-specified to be assessed for the "Auricular Acupressure Group" Arm only. | 3 in Treatment with missing data. | Posted | Mean | Standard Deviation | number of pellets | Up to post-operatively day 4 | Pellets | Pellets |
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| Secondary | Number of Participants Who Responded They Were Satisfied With Pain Management | Likert scale with a total score of 0 to 6--higher scores denotes worse outcomes. Force choice: very satisfied, satisfied, somewhat satisfied, somewhat dissatisfied, dissatisfied, very dissatisfied. Any degree of satisfaction compared to any degree of dissatisfaction. Satisfied included responses very satisfied to somewhat satisfied | 8 in Treatment and 5 in Standard of Care (SOC) group with missing data. Results indicate number of respondents who endorsed they were satisfied (very satisfied to somewhat satisfied) with pain management. | Posted | Count of Participants | Participants | post-operatively day 4 |
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| Secondary | Number of Participants Who Responded "Yes, Would Definitely Consider Using in the Future." | Participants were asked if they "would consider using auricular acupressure in the future for pain if recommended by a nurse or physician?" Possible answers are "no, would not use again", "maybe", or "Yes, would definitely consider using in the future." | 6 in Treatment and 5 in Standard of Care (SOC) group with missing data. Results are percent of total respondents who selected: "Yes, would definitely consider using in the future." | Posted | Count of Participants | Participants | post-operatively day 4 |
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| Secondary | Nurse Time to Deploy Pellets | Reported as the number of minutes that it took nurse interventionists to place acupressure seeds (pellets), activate, and provide instruction. | Data collected while inpatient on all 30 participants in treatment arm. Missing data on 2 participants. This outcome applies to the AA group only. | Posted | Median | Full Range | minutes | post-operatively day 5 |
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| Secondary | Number of Nurse Concerns Reported | Review nurse reports in encounters. Count number of concerns pooled across all participants in encounters with disruption of workflow due to care unit or patient barriers documented while participant was in hospital. Concerns included workflow and patient barriers. This outcome applies to nurse interventionists arm only. | Posted | Number | number of concerns reported | post-operatively day 0 and 1 | encounters | encounters |
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| 0 |
| 30 |
| 0 |
| 30 |
| 1 |
| 30 |
| EG001 | Standard of Care Group | Standard of care pain management: The participant post-operative pain will be managed following the standard protocol by the treating physician. | 0 | 30 | 0 | 30 | 0 | 30 |
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| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |