Battlefield Auricular Acupressure (BAApress) for Emergency Department Observation Psychiatric Patients With Co-occurring Chronic and Acute Pain Management
Phase: NA
Conditions: Pain
Sponsor: Wake Forest University Health Sciences

Protocol Date: 03-13-2023 
Page 1 
 
Study Title:  Battlefield auricular acupressure (BAApress) for Emergency Department 
Observation of psychiatric patients with co-occurring chronic and acute pain management. 
 
Principal Investigator PI: Michelle Olshan-Perlmutter, PMHCNS, NP  
Co-investigators: Kelly R. Hobgood, MD; Carolyn Huffman, WHNP, PhD 
Study Coordinator: Nicolas Archer, MSN;  
Study Staff: Jean May 
 
Sponsor or funding source: Departmental 
 
Background, Rationale and Context 
Pain can have a significant impact on psychiatric patients, as it can exacerbate symptoms and 
interfere with treatment. Pain can cause or worsen anxiety and depression, is associated with 
increased disability and poorer quality of life in people with severe and persistent mental 
illness. (Birgenheir et. al., 2013, Onwumere et al., 2022, Stubbs et al., 2015).  Additionally, both 
severe and persistent mental illness and pain are associated with increased suicide risk (Fu XL et 
al., 2021, Racine, 2015). 
 
Evidence suggests that individuals with mental illness may be one population with particularly 
high rates of chronic non cancer pain (CNCP) and may also be more likely to receive 
prescription opioids for their pain (6). Individuals with serious mental illness, who are most at 
risk for developing opioid-related problems, continue to be prescribed opioids more often than 
their peers without mental illness (Owen-Smith et al., 2020).   
 
As of January 1, 2018, The Joint Commission requires hospitals to have non-pharmacologic 
modalities available for pain management in an effort to decrease the need for opioids.  
Acupuncture and acupressure have been used for centuries in the management of a variety of 
disorders including pain.  A recent meta-analysis (Zhong et al., 2019) of 26 RCTs (all included 
studies were in China) favored the use of acupressure for pain management over usual care 
based on total effective rate (RR =1.25, [CI= 1.13, 1.37], p <.0001) and total analgesia use 
(RR=0.41, [CI= 0.24, 0.68] p = .0006).  There were no serious adverse events reported in the 26 
trials (N=1063 in treatment groups) and no withdrawals from the studies were reported due to 
adverse events. More recently, in an effort to increase access to non-pharmacological 
modalities for pain management, the VA has developed a battlefield auricular acupressure 
(BAApress) protocol.   Unlike acupuncture, acupressure can be easily applied with training and 
is within the scope of practice for nurses, according to the North Carolina Board of Nursing 
(NCBON, 2013).  Although acupressure has been used for centuries in traditional Chinese 
medicine, there are few studies assessing the use of nurse-initiated acupressure as an adjuvant 
for co-occurring pain. Thus, we propose assessing the effectiveness of BAApress for chronic and 
acute pain management for psychiatric patients in a psychiatric emergency room setting.  In 
addition, by analyzing measures and demographics we hope identify patients that may benefit 
most from BAApress acupressure.  
 

Protocol Date: 03-13-2023 
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This feasibility study is being performed in collaboration with the BAApress training and 
Intervention Fidelity study IRB00084011. This study is similar to Fidelity study IRB00068022, 
Auricular Acupressure for Pain Management as a Non-Opioid Adjuvant Therapy for Opioid 
Tolerant Patients (PI Heather Columbano).  The purpose of this study is to test the feasibility of 
Emergency Department nurse-initiated battlefield auricular acupressure as an adjunct to 
medication for pain management for psychiatric Emergency Department Observation patients.  
The Battlefield Auricula Acupressure interventionists (nurse) will complete Auricular training 
modules and complete competency assessments and intervention assessments throughout the 
study. Study interventionist will include the possibility that a study participant may be part of a 
competency assessment and that their session may be recorded and securely uploaded to a 
server per IRB and institutional policies.  
 
 
Objectives 
1. To determine psychiatric patients’ acceptance of BAApress as an adjunct treatment 
to address co-occurring pain.    
2. To determine if the addition of BAApress protocol will lower pain scores and   
decrease pain medication usage. 
3. To determine ability of ED nurses to incorporate BAApress into their workflow.   
 
 
Methods and Measures 
 
Design 
             Feasibility trial, no control group  
   
             Setting: 
This study will utilize the location of Atrium Health Behavioral Health Charlotte 
Emergency Department ED and Observation unit for initiation of study procedures. 
 
 
Subject Selection Criteria 
Any patient admitted to Behavioral Health Charlotte Emergency Department Observation Unit 
for psychiatric reasons and with co-occurring pain. 
 
• Inclusion Criteria 
Patients requiring admission to psychiatric emergency room who also have 
documented chronic or acute pain  
1. Age greater or equal to 18 
2. History of chronic or acute pain with or without opioid use disorder 
3. Expected length of stay at least 2-3 days at the time of recruitment 
4. Able to read and understand the informed consent form 
 

Protocol Date: 03-13-2023 
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• Exclusion Criteria 
1. Since this is a feasibility pilot, only English-speaking participants will be 
eligible.  
2. Cognitive impairment (Intellectual Disability Disorder or Dementia) 
3. Patients who have a legal guardian  
4. Participants with a history of skin disease (e.g., psoriasis) involving the ear, 
adhesive allergy, recent scar tissue on ear, or current abrasions or cuts on ear, 
5.  Use of some types of hearing aids (obstructing the placement of beads)  
 
• Sample Size 
A total of between 10-20 patients will be recruited from Atrium Health BH Charlotte 
ED Observation unit   
 
 
Interventions and Interactions 
 
Terms:   AA = Auricular acupressure  
Acupressure pad= hypoallergenic adhesive pad containing a 2 mm Vaccaria 
seeds (Earseeds®)  
 
 
 Acupoint = specific area of body where acupressure is applied. 
 BAApress= Battlefield Auricular Acupressure       
 
• Participants will be informed of the study once they are identified by the behavioral 
health care team, which includes patient’s psychiatric provider and medical 
consultation provider as an appropriate candidate.  
• Informed consent will be obtained by study personnel or the interventionist, the 
BAApress interventionist will confirm consent for participation.   
• A study team member will perform visual analogue Scale and Brief Pain Inventory 
with the participant to establish baseline pain score and impact pain has on general 
activity, mood, walking ability, normal work, relationship with other people, sleep 
and enjoyment.  
• The participant will be asked to also complete baseline questionnaires prior to the 
initiating placement of the AA including data collection form and General Anxiety 
Disorder Scale (GAD-7)- A self-administered 7 item scale that draws from DSM-V 
criteria for general anxiety disorder (GAD) to identify GAD and measure symptom 
severity. It is routinely used to measure changes and track treatment progress. 
• BAApress interventionists will record the time from the moment they meet with 
the patient in an available room for the purposes of placing acupressure pads and 
activating each pad until they exit the room.  BAApress interventionists will make 
notation if recorded time includes activity unrelated to placement of acupressure 
pads.  After placement of acupressure pads, BAApress interventionist will enter 
procedure note in a shared specific file for interventionist and complete the 
REDCap nurse questionnaire. 
 

Protocol Date: 03-13-2023 
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Day 1 
The baseline and day 1 activity can take place on the same day, but it is not required. 
Following completion of informed consent and baseline questionnaires, the trained 
BAApress interventionist nurse will place the acupressure pads. 
 
o If the ear contains lesions, skin breakdown, or show signs of irritation, the 
acupressure pads will not be placed, and this will be noted in the study record.   
 
o If the participant consented to the recording portion of the study, they will be 
reminded of the process and the BAApress acupressure nurse will confirm that 
the participant still agrees to participate in the recording portion of the study. 
 
o Acupressure pads will be placed prior to any pain medication. 
 
o A total of 10 adhesive acupressure pads will be placed, 5 acupressure pads per 
ear. Patients will be given a handout showing location of each point where 
acupressure pad will be placed. The pads will be placed bilaterally on the 
following 5 auricular sites: 1) Cyngulate gyrus, 2) Thalamus, 3) Omega 2 4) Point 
Zero, and 5) Shen Men. These sites were selected based on the Veterans 
Administration Battlefield Auricular Acupressure Protocol for acute and chronic 
pain. This is the protocol the Veterans Administration uses for acupressure 
therapy for acute and chronic pain management and is taught to both nurses and 
physicians.   
 
o Each ear will be cleansed with alcohol, beginning at the base of the ear (lobule) 
to the apex.  The acupoints will be visually located and marked with a sterile 
surgical marker.   
 
o The pads will be placed by visual identification of the preselected acupoints as 
per BAApress protocol. The pads will be placed on the on the identified site by 
hand or with the assistance of tweezers, with the seed portion of the pad aligning 
with the identified acupoint. 
 
o To secure the pad, gentle but firm pressure will be applied to the pad, making 
sure that pressure is applied to the entire pad. 
 
o After placement, the interventionist will apply moderate pressure to each 
acupressure pad for 30 seconds (total time 2.5 minutes per ear). Both right and 
left ear site will be stimulated at the same time with pressure in the following 
order: 1) Cyngulate gyrus, 2) Thalamus, 3) Omega 2, 4) Point Zero, and 5) Shen 
Men.   
 
o Participants will tell the BAApress interventionist nurse when they feel a tingling 
sensation in the ear or feel moderate tenderness or pressure as confirmation 

Protocol Date: 03-13-2023 
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that moderate pressure is being applied. Description of sensations felt by 
participant will be recorded by the BAApress interventionist. 
 
o The BAApress interventionist will document pad placement and activation in 
EPIC.  
 
o BAApress interventionist will review with participant how and when to activate 
each pad and give participant a picture of a right and left ear with the 
acupressure points location on each ear. Participants will be reminded to gently 
press on each pad for 30 seconds at least three times a day to activate for a 
total of 3 days.  
 
o If the acupressure pads fall off before day 3, they will not be replaced. The 
BAApress interventionist will record the missing pad/pads. 
 
o After completion of day 3 study activities, the study team will remove the 
acupressure pads by gently pulling on the edges of the pad and lifting off with 
their fingers or using tweezers to loosen the pad if needed. 
 
o If participants are discharged prior to 3 days, they will be contacted via 
telephone call by study personnel and/or via text messaging depending on 
participant preference to remind them to complete the questionnaire and to 
activate their pads 3 times per day.  
 
o At the end of the third day, the study personnel will call the patient, or they will 
receive a text letting them know the study team needs to arrange a telephone 
call to provide   instruction on how to remove the acupressure pads. If 
participant cannot be reached by phone, they will be instructed on removing 
pads by gently pulling on the edges of the pad and lifting off with their fingers 
or using tweezers to loosen the pad if needed. Participants will be reminded to 
complete final post intervention questionnaires after removal of pads that 
study personnel will review with them.   
 
o The BAApress interventionist nurse may record and take pictures of the 
treatment visit. These recordings will be used to ascertain fidelity to the 
intervention protocol as it relates to a) proper placement of acupressure seeds 
and b) provision of instructions to the participant. 
 
o Each study participant will be asked to sign a separate consent giving 
permission for the intervention to be recorded and used for education and 
research purposes. The recordings will be done to limit exposure of the study 
participant’s face.  
 

Protocol Date: 03-13-2023 
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o The study team will perform Visual Analogue Scale (VAS) and Brief Pain 
Inventory with participants one to two times a day for 3 days. 
 
o The study team will have the participant  complete GAD-7 every morning for 3 
days. 
 
o The study team will complete BAApress Questionnaire daily with participant 
every morning for 3 days. 
 
 
End of Study Assessment 
Verify completion of day 5 study questionnaires:  VAS, Brief Pain Inventory, GAD-7, 
BAApress Questionnaire and Pain Management Satisfaction 
 
Primary Outcomes 
Patient reported pain and general activity scores (Visual Analogue Scale) and (Brief Pain 
Inventory) 
 
Secondary Outcomes to be measured: 
• Pain medication usage. Trajectory of am and pm pain scores 
• General Anxiety Disorder Scale (GAD-7). Patients are asked to rate the frequency of 
anxiety symptoms daily on a Likert scale (0-3). In general, patients with GAD or 
other common anxiety disorders exhibit GAD-7 scores of 10 or greater. 
• Pain Management Satisfaction to determine patient satisfaction 
• Acupressure Acceptability questions - We will ask acceptability questions. "How 
satisfied were you with how your pain has been treated?" using the Likert scale to 
measure "Very satisfied =5, Satisfied=4, Somewhat satisfied = 3, Somewhat 
dissatisfied= 2, Dissatisfied 1, Very Dissatisfied 0.”  Would you consider using 
auricular acupressure in the future for pain or if recommended by your nurse or 
physician? a. No, would not use again (Score of 0) b. Maybe (Score of 1), c. Yes, I 
would consider using in the future (Score of 2) 3. Is there anything else you would 
like to tell us that may be helpful for us to know regarding ear acupressure? (Each 
answer will be collected and assessed for future studies). 
• BAA Press placement survey (interventionists only): The Interventionist (Acupressure 
nurse) will be asked to capture time related to completion of study tasks and other 
qualitative questions to assess overall feasibility. 
• Additional Data collection: contact information, relevant demographic data that will 
be recorded are: DOB, age, gender, ethnicity/race.  Relevant medical history will be 
duration of pain medications including narcotic use (in years) and comorbid chronic 
or acute pain diagnoses.  
 
 
 

Protocol Date: 03-13-2023 
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Study activity 
Baselinea 
Day 1 
Day 2 
Day 3/End of 
study 
Informed Consent 
signed 
x 
 
 
 
Data Collection 
Form  
x 
x 
x 
x 
Complete Baapress 
Questionnaire 
x 
x 
x 
x 
Administer or 
record Pain score 
assessment (VAS)b 
x 
x 
x 
x 
Brief Pain Inventory 
x 
x 
x 
x 
Pain Management 
Satisfaction  
 
 
 
x 
Generalized Anxiety 
Disorder Scale 
(GAD-7) 
x 
x 
x 
x 
Acupressure 
placement and 
patient education  
 
x 
 
 
*Optional 
interventionist 
recording of AA 
placementd 
 
x 
 
 
Study team collect 
completed 
questionnaire 
 
 
 
x 
Compensation 
administration 
 
 
 
x 
BAA press 
placement survey 
(interventionist 
only) 
x 
x 
x 
x 
 
 
 
 
 
 
a Baseline and Day 1 can be completed on the same day. Baseline activities are to be 
completed prior to Acupressure administration. 
b The study team will perform the pain score assessment with the participant two 
times a day for three days.  
 c Participants will receive reminders to complete the study questionnaires if 
discharged prior to 3 days. 
d Only participants who agree to participate in the optional recording/photography at 
the time of informed consent will have their acupressure placement session recorded.  

Protocol Date: 03-13-2023 
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Analytical Plan 
Sample Size: This is a feasibility study with no control group. Target enrollment is 10- 20 
participants. Data from this study will be used to generate parameter estimates to calculate 
power for future studies.  
 
Results will be analyzed initially using descriptive statistics. Any group comparisons will be done 
using chi square tests for proportions, and t-tests or ANOVA procedures for continuous 
variables.   
 
Human Subjects Protection 
Good Clinical Practices and HIPAA guidelines will be followed to ensure the safety and wellbeing 
of patients electing to participate in this study. PHI used during this study will be collected and 
recorded in accordance with the standards set forth in the Health Insurance Portability and 
Accountability Act (HIPAA). Confidentiality of medical information will be maintained 
throughout the study. All paper case report forms (CRFs) and informed consent forms (ICFs) will 
be stored in a locked drawer. Study participants will be assigned a unique identifier that will be 
used on CRFs. Data collected for this COVID-19 ALS Registry will also be stored and analyzed 
electronically in Atrium Health’s REDCap Database. REDCap is a secure web platform for 
building and managing online database projects and surveys and is used extensively by 
academic and research institutions. This REDCap study will further restrict access to study staff.  
 
Subject Recruitment Methods 
To assist with recruitment. Patients when admitted to Atrium Behavioral Health Emergency 
Room may be identified by screening behavioral health treatment team and referred to study 
personnel.  
 
Study personnel will review eligibility and approach patient regarding participation.  Only 
eligible patients willing to complete all survey’s pre and post procedures and provide written 
consent will participate.  The study team will ensure that the participant understands the 
voluntary nature of participating in the research study and that study participation study will 
not affect the care that they will receive.  
The study personnel will maintain a record of eligible study participants.  This list will include 
name, MRN, psychiatric and pain diagnosis, and will be kept in a secure file on a secure 
computer and only accessible to study staff. The file of eligible participants will be destroyed at 
the end of recruitment. 
 
Compensation 
Participants completing the study will receive $25.00 in a Walmart gift card.  
 
Informed Consent 
Signed informed consent will be obtained from each subject.  The study personnel will obtain 
informed consent at the time participant is admitted to Observation unit and it is determined 
patient meets criteria. No study procedures will begin until the IRB approved method of 
obtaining consent is completed.  

Protocol Date: 03-13-2023 
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Confidentiality and Privacy 
Confidentiality will be protected by collecting only information needed to assess study 
outcomes, minimizing to the fullest extent possible the collection of any information that could 
directly identify subjects, and maintaining all study information in a secure manner. To help 
ensure subject privacy and confidentiality, only a unique study identifier will appear on the 
stored data collection forms.  Any collected patient identifying information corresponding to 
the unique study identifier will be maintained on a linkage file, store separately from the data.  
The linkage file will be kept secure, with access limited to designated study personnel.   
 
Following data collection, subject identifying information will be destroyed three years after the 
completion of the study consistent with data validation and study design, producing an 
anonymous analytical data set. Data access will be limited to study staff.  Data and records will 
be kept locked and secured with any computer data password protected.  No reference to any 
individual participant will appear in reports, presentations, or publications that may arise from 
the study. 
 
Data and Safety Monitoring 
The principal investigators will be responsible for the overall monitoring of the data and safety 
of study participants.  The principal investigators will be assisted by other members of the study 
staff. Although no serious safety events have been reported in the literature related to auricular 
acupressure, participants will be asked to report any events to study personnel.  Participants 
and the acupressure nurses will be instructed to monitor and report any concerns to the 
principal investigators.  
 
Reporting of Unanticipated Problems, Adverse Events or Deviations 
Any unanticipated problems, serious and unexpected adverse events, deviations or protocol 
changes will be promptly reported by the principal investigator or designated member of the 
research team to the IRB and sponsor or appropriate government agency if appropriate. 
 
      Appendix A: Data Collection Form 3 9 23 
      Appendix B: BAApress Questionnaire1  
      Appendix C: Brief Pain Inventory  
      Appendix D: PainManagementSatisfaction_Bat 
      Appendix E: GAD-7 Anxiety Scale 
      Appendix F: BAApressPlacement_BattlefieldA (For Interventionist use) 
      Appendix G: Vaccaria 600 EarSeeds Package Insert 
      Appendix H: Visual Analogue Scale 
  
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