Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2024-07-31
2025-10-31
Brief Summary
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Detailed Description
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This feasibility trial is being conducted in collaboration with the Battlefield Auricular Acupressure (BAApress) Training and Intervention Fidelity study (IRB00084011).
Conditions
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Study Design
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NA
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
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Auricular Acupressure (AA) Group
Participants will receive the AA intervention over a 5 day period in addition to their Standard of Care treatment for Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS), and complete daily study questionnaires
Auricular Acupressure
Auricular Acupressure (AA) utilizing all-natural vaccaria ear seeds will be applied to 5 designated sites on each participant's ear (total of 10 seeds placed per patient).
Participants will be asked if they consent to having their ear placement photographed after placement (optional) and audio recorded during interventionist ear seed placement (optional) in collaboration with the BAApress training fidelity study.
Interventions
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Auricular Acupressure
Auricular Acupressure (AA) utilizing all-natural vaccaria ear seeds will be applied to 5 designated sites on each participant's ear (total of 10 seeds placed per patient).
Participants will be asked if they consent to having their ear placement photographed after placement (optional) and audio recorded during interventionist ear seed placement (optional) in collaboration with the BAApress training fidelity study.
Eligibility Criteria
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Inclusion Criteria
* History of documented interstitial cystitis/bladder pain syndrome (IC/BPS)
* Able to read and understand informed consent form in English
Exclusion Criteria
* Cognitive impairment (e.g. delirium, dementia)
* Physical impairment preventing them from applying daily pressure/stimulation to ear seeds
* Patients with cardiac pacemakers (contraindication to POINTER PAL)
* Use of some types of hearing aids (which could potentially obstruct placements of ear seeds)
* Any acute illness or psychiatric conditions that would impact adherence to the study requirements
18 Years
80 Years
ALL
No
Sponsors
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Wake Forest University Health Sciences
OTHER
Responsible Party
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Principal Investigators
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Stephen Walker, PhD
Role: PRINCIPAL_INVESTIGATOR
Wake Forest University Health Sciences
Other Identifiers
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IRB00090489
Identifier Type: -
Identifier Source: org_study_id
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