Pain, Acute, Pain, Postoperative
Conditions
Keywords
auricular acupressure, anesthesia
Brief summary
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.
Detailed description
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.
Interventions
DEVICEAuricular 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.
OTHERStandard of care pain management
The participant post-operative pain will be managed following the standard protocol by the treating physician.
Sponsors
Wake Forest University Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Statistician blinded to study arms during analysis phase.
Intervention model description
Arm 1 Treatment group, Arm 2 Control group, Arm 3 Nurse Interventionist group
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Adults 18-80 admitted for knee or hip arthroplasty * Pre-surgery morphine equivalent \< 50 * American Society of Anaesthesiologists (ASA) score \< 3
Exclusion criteria
* Participants with a history of skin disease (psoriasis), adhesive allergy, history of delirium, or cognitive impairment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analogue Pain Scale | Up to Post-operatively day 4, at rising approximately 6 am | 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. |
| Medication Use - Outpatient Opioids | Up to post-operatively day 4 | Amount of medication use after discharge recorded in total morphine equivalent dose from discharge through day 4 postoperatively |
| Medication Use - Inpatient Opioids | Up to post-operatively day 4 | Amount of medication recorded in morphine equivalent dose while in hospital (not including anesthesia) |
| Medication Use - Total Other Analgesics | Up to post-operatively day 4 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Responded They Were Satisfied With Pain Management | post-operatively day 4 | 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 |
| Nurse Time to Deploy Pellets | post-operatively day 5 | Reported as the number of minutes that it took nurse interventionists to place acupressure seeds (pellets), activate, and provide instruction. |
| Number of Participants Who Responded Yes, Would Definitely Consider Using in the Future. | post-operatively day 4 | 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. |
| Number of Nurse Concerns Reported | post-operatively day 0 and 1 | 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. |
| Visual Analogue Pain Scale | Baseline | Average pain upon awakening score from 0 to 10 using visual analogue scale (0= no pain, 10= worst pain). |
| Mean Number of Pellets Retained | Up to post-operatively day 4 | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 30 |
| 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. | 30 |
| Total | 60 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 2 | 3 | 0 |
| Overall Study | participant stopped treatment but submitted partial data. | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | Standard of Care Group | Total | Auricular Acupressure Group |
|---|---|---|---|
| Age, Continuous | 66 years STANDARD_DEVIATION 8.3 | 66 years STANDARD_DEVIATION 9 | 66 years STANDARD_DEVIATION 9.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 2 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 29 Participants | 58 Participants | 29 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) White | 29 Participants | 56 Participants | 27 Participants |
| Region of Enrollment United States | 30 participants | 60 participants | 30 participants |
| Sex: Female, Male Female | 19 Participants | 39 Participants | 20 Participants |
| Sex: Female, Male Male | 11 Participants | 21 Participants | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 30 | 0 / 30 |
| other Total, other adverse events | 1 / 30 | 0 / 30 |
| serious Total, serious adverse events | 0 / 30 | 0 / 30 |
Outcome results
Primary
Medication Use - Inpatient Opioids
Amount of medication recorded in morphine equivalent dose while in hospital (not including anesthesia)
Time frame: Up to post-operatively day 4
Population: Data obtained from hospital medication administration record on all participants.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Auricular Acupressure Group | Medication Use - Inpatient Opioids | 37.8 MME | Standard Deviation 28.3 |
| Standard of Care Group | Medication Use - Inpatient Opioids | 35.8 MME | Standard Deviation 28.6 |
p-value: 0.86ANCOVA
Primary
Medication Use - Outpatient Opioids
Amount of medication use after discharge recorded in total morphine equivalent dose from discharge through day 4 postoperatively
Time frame: Up to post-operatively day 4
Population: 1 in Treatment group and 1 in Standard of Care (SOC) group with missing data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Auricular Acupressure Group | Medication Use - Outpatient Opioids | 74.2 morphine milligram equivalents | Standard Deviation 58.9 |
| Standard of Care Group | Medication Use - Outpatient Opioids | 88.6 morphine milligram equivalents | Standard Deviation 73.1 |
p-value: 0.64ANCOVA
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.
Time frame: Up to post-operatively day 4
Population: 1 in Treatment group and 3 in Standard of Care (SOC) group with missing data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Auricular Acupressure Group | Medication Use - Total Other Analgesics | 13643 milligrams | Standard Deviation 4615 |
| Standard of Care Group | Medication Use - Total Other Analgesics | 13766 milligrams | Standard Deviation 3395 |
p-value: 0.661ANCOVA
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.
Time frame: Up to Post-operatively day 4, at the end of the day approximately 10 pm
Population: 3 in Treatment group and 3 in Standard of Care (SOC) group with missing data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Auricular Acupressure Group | Visual Analogue Pain Scale | 5.27 units on a scale | Standard Deviation 2.51 |
| Standard of Care Group | Visual Analogue Pain Scale | 6.11 units on a scale | Standard Deviation 2.21 |
p-value: 0.29ANCOVA
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.
Time frame: Up to Post-operatively day 4, at rising approximately 6 am
Population: 1 in Treatment and 2 in Standard of Care (SOC) group with incomplete missing data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Auricular Acupressure Group | Visual Analogue Pain Scale | 3.03 units on a scale | Standard Deviation 2.04 |
| Standard of Care Group | Visual Analogue Pain Scale | 4.37 units on a scale | Standard Deviation 2.18 |
p-value: 0.048ANCOVA
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.
Time frame: Up to post-operatively day 4
Population: 3 in Treatment with missing data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Auricular Acupressure Group | Mean Number of Pellets Retained | 7.38 number of pellets | Standard Deviation 4.15 |
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.
Time frame: post-operatively day 0 and 1
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Auricular Acupressure Group | Number of Nurse Concerns Reported | 10 number of concerns reported |
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
Time frame: post-operatively day 4
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Auricular Acupressure Group | Number of Participants Who Responded They Were Satisfied With Pain Management | 19 Participants |
| Standard of Care Group | Number of Participants Who Responded They Were Satisfied With Pain Management | 21 Participants |
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.
Time frame: post-operatively day 4
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Auricular Acupressure Group | Number of Participants Who Responded Yes, Would Definitely Consider Using in the Future. | 19 Participants |
| Standard of Care Group | Number of Participants Who Responded Yes, Would Definitely Consider Using in the Future. | 13 Participants |
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.
Time frame: post-operatively day 5
Population: Data collected while inpatient on all 30 participants in treatment arm. Missing data on 2 participants. This outcome applies to the AA group only.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Auricular Acupressure Group | Nurse Time to Deploy Pellets | 13.5 minutes |
Secondary
Visual Analogue Pain Scale
Average pain upon awakening score from 0 to 10 using visual analogue scale (0= no pain, 10= worst pain).
Time frame: post-operatively day 1, at the end of the day
Population: 1 in Standard of Care group with missing data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Auricular Acupressure Group | Visual Analogue Pain Scale | 5.64 units on a scale | Standard Deviation 3.11 |
| Standard of Care Group | Visual Analogue Pain Scale | 6.46 units on a scale | Standard Deviation 2.54 |
Secondary
Visual Analogue Pain Scale
Average pain upon awakening score from 0 to 10 using visual analogue scale (0= no pain, 10= worst pain).
Time frame: post-operatively day 2, at the end of the day
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Auricular Acupressure Group | Visual Analogue Pain Scale | 5.79 units on a scale | Standard Deviation 2.73 |
| Standard of Care Group | Visual Analogue Pain Scale | 6.48 units on a scale | Standard Deviation 2.41 |
Secondary
Visual Analogue Pain Scale
Average pain upon awakening score from 0 to 10 using visual analogue scale (0= no pain, 10= worst pain).
Time frame: post-operatively day 3, at the end of the day
Population: 2 in Treatment with missing data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Auricular Acupressure Group | Visual Analogue Pain Scale | 4.78 units on a scale | Standard Deviation 2.74 |
| Standard of Care Group | Visual Analogue Pain Scale | 6.27 units on a scale | Standard Deviation 2.49 |
Secondary
Visual Analogue Pain Scale
Average pain upon awakening score from 0 to 10 using visual analogue scale (0= no pain, 10= worst pain).
Time frame: post-operatively day 4, at the end of the day
Population: 3 in Treatment and 3 in Standard of Care (SOC) group with missing data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Auricular Acupressure Group | Visual Analogue Pain Scale | 4.47 units on a scale | Standard Deviation 2.75 |
| Standard of Care Group | Visual Analogue Pain Scale | 5.80 units on a scale | Standard Deviation 2.46 |
Secondary
Visual Analogue Pain Scale
Average pain upon awakening score from 0 to 10 using visual analogue scale (0= no pain, 10= worst pain).
Time frame: post-operatively day 1, at rising
Population: Data from other participant in treatment group who stopped study treatment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Auricular Acupressure Group | Visual Analogue Pain Scale | 3.05 units on a scale | Standard Deviation 2.36 |
| Standard of Care Group | Visual Analogue Pain Scale | 3.90 units on a scale | Standard Deviation 2.52 |
Secondary
Visual Analogue Pain Scale
Total score 0 to 10 on visual analogue scale, anchors 0=no pain, 10 equals worse pain.
Time frame: post-operatively day 2, at rising
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Auricular Acupressure Group | Visual Analogue Pain Scale | 3.76 units on a scale | Standard Deviation 2.79 |
| Standard of Care Group | Visual Analogue Pain Scale | 5.01 units on a scale | Standard Deviation 2.7 |
Secondary
Visual Analogue Pain Scale
Average pain upon awakening score from 0 to 10 using visual analogue scale (0= no pain, 10= worst pain).
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Auricular Acupressure Group | Visual Analogue Pain Scale | 2.30 units on a scale | Standard Deviation 2.28 |
| Standard of Care Group | Visual Analogue Pain Scale | 2.84 units on a scale | Standard Deviation 2.69 |
Secondary
Visual Analogue Pain Scale
Average pain upon awakening score from 0 to 10 using visual analogue scale (0= no pain, 10= worst pain).
Time frame: post-operatively day 3, at rising
Population: 2 in Treatment with missing data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Auricular Acupressure Group | Visual Analogue Pain Scale | 2.60 units on a scale | Standard Deviation 2.02 |
| Standard of Care Group | Visual Analogue Pain Scale | 4.46 units on a scale | Standard Deviation 2.42 |
Secondary
Visual Analogue Pain Scale
Average pain upon awakening score from 0 to 10 using visual analogue scale (0= no pain, 10= worst pain).
Time frame: post-operatively day 4, at rising
Population: 2 in Treatment and 2 in Standard of Care (SOC) group with missing data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Auricular Acupressure Group | Visual Analogue Pain Scale | 2.81 units on a scale | Standard Deviation 2.13 |
| Standard of Care Group | Visual Analogue Pain Scale | 4.25 units on a scale | Standard Deviation 2.37 |