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Integrating Auricular Point Acupressure Into Real-world Nursing Practice to Manage Cancer-related Pain

Primary Purpose

Cancer-related Pain, Acupressure

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
APA Treatment
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cancer-related Pain focused on measuring Auricular Point Acupressure, Cancer-related Pain, Acupressure, Nursing education

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Cancer patients with worst pain rated as 4 or more on a 0-10 numeric rating scale in the last 24 hours, which will use the EPIC pain scale
  • Able to read and write English
  • Able to apply pressure to the seeds taped to the ears. Patients with any cancer type will be eligible for this study so long as the patients are experiencing cancer-related pain
  • Owns a smartphone

Exclusion Criteria:

  • Is delirious
  • Has ear skin disease
  • Non-English speaker
  • Has latex allergy to the tape used for this study
  • Women who are pregnant

Sites / Locations

  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

APA Treatment

Arm Description

Oncology patients with a pain rating of four or greater will receive APA treatment for patients' cancer-related pain. The ear points will be determined by the corresponding body points related to the patient's specific pain. Pain data will be tracked by electronic surveys and Electronic Health Records.

Outcomes

Primary Outcome Measures

Change in Pain Intensity as assessed by the Brief Pain Inventory (BPI) short form
Pain intensity in the last 24 hours (1) at its worst and (2) on average will both be measured on a scale of 0 (no pain) to 10 (pain as bad as you can imagine).
Change in Pain Interference as assessed by the Brief Pain Inventory (BPI) short form
Pain interference with general activity, mood, walking ability, normal work, relationships with other people, sleep and enjoyment of life will be measured on a scale of 0 (does not interfere) to 10 (completely interferes).
Change in Dose of Analgesic Use
Dose of analgesic use will be collected in electronic health record (EHR) as part of routine nursing assessments for patient care.

Secondary Outcome Measures

Change in Fatigue as assessed by a 0 to 10 scale
Fatigue will be measured on a scale of 0 (energetic, no fatigue) to 10 (worst possible fatigue).
Change in Quality of Sleep as assessed by a 0 to 10 scale
Sleep quality will be measured on a scale of 0 (very poor) to 10 (very good).

Full Information

First Posted
July 30, 2019
Last Updated
August 6, 2021
Sponsor
Johns Hopkins University
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1. Study Identification

Unique Protocol Identification Number
NCT04040140
Brief Title
Integrating Auricular Point Acupressure Into Real-world Nursing Practice to Manage Cancer-related Pain
Official Title
Integrating Auricular Point Acupressure Into Real-world Nursing Practice to Manage Cancer-related Pain
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Terminated
Why Stopped
Due to Covid 19.
Study Start Date
October 8, 2019 (Actual)
Primary Completion Date
January 30, 2021 (Actual)
Study Completion Date
January 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The aims of this proposal are to (1) examine the feasibility of providing a training course of Auricular Point Acupressure (APA) for clinical oncology nurses who can integrate APA into real-world nursing care settings and (2) examine the effectiveness of APA on cancer-related pain (CRP) under the usual conditions.
Detailed Description
Cancer-related pain (CRP) is considered one of the most challenging symptoms that cancer patients experience. Opioid use is the most common strategy to manage pain. However, pharmacological treatments are associated with a variety of adverse side effects, including drowsiness, constipation, dry mouth, and the potential for addiction. As a result, up to 52% of cancer patients do not receive adequate analgesic medication. The high prevalence of pain and ineffective CRP management highlight the limitations of current CRP strategies. An effective, nonpharmacological patient-managed strategy-that has potential to provide quick and low-cost pain relief without new side effects-is an essential next step to manage CRP. Auricular point acupressure (APA), a non-invasive and nonpharmacological patient-managed strategy, can be an innovative solution for CRP. APA is derived from Chinese Medicine and is different from auricular acupuncture, which is an invasive (using needles) and passive treatment (administered by a licensed practitioner). APA is a non-invasive and active treatment for patients with pain and other symptoms. It involves needleless, acupuncture-like stimulation of ear points. Small seeds are taped on specific ear points for stimulation by patients. Once the seeds have been taped on the patient's ear by the skilled provider, the patient is able to co-manage patient's treatment at home. APA is popular in Taiwan, China, and Europe. Though its use is limited in the U.S., a limited number of clinical trials have supported APA. To achieve pain relief, the participant presses on the seeds to stimulate ear points three times daily, three minutes per time, for a total of nine minutes per day. APA provides pain relief within 1-2 minutes after ear stimulation and also sustains pain relief for one month after a 4-week APA intervention. The rapid pain relief makes APA an attractive strategy to manage CRP. The investigators' team has conducted a series of APA studies among patients with (1) chronic low back pain, (2) aromatase inhibitor musculoskeletal symptoms (AIMSS), (3) persistent post-mastectomy pain, and (4) chemotherapy-induced neuropathy (CIN). All of the investigators' pilot studies demonstrated better than a clinically significant pain reduction (30% reduction) after 4 weeks of APA and sustained effects for 1-month. Significant plasma inflammatory changes (IL-1β, IL-2, IL-6, Tumor Necrosis Factor α, and IFNγ) were found after 4 weeks, indicating that APA may affect brain macrophage-cells resulting in inflammatory cytokines alterations, leading to sustained pain relief at 1-month follow-up. Based on these findings, the investigators believe APA would be particularly suitable to reduce CRP. More importantly, easy implementation of APA and its immediate and lasting pain relief can empower and motivate cancer patients to adhere to APA treatment and allows patients to engage other forms of pain intervention, such as maintaining and/or increasing physical activity as a by-product of improved analgesia. Nurses are the patient's first line of support in managing CRP; however, nurses have limited tools available to accomplish this. The most common treatments that nurses have at nurses' disposal are the usage of analgesics or referrals to specialty consultations. Once patients are referred, the role of nurses as cohesive guides and caretakers is often lost. To address this dilemma, patients and nurses need access to a therapy that can quickly relieve the pain, which, in turn, reduces the analgesic use and encourages patients and nurses to engage in other pain interventions. Due to the non-invasive characteristic of APA, nurses can learn APA and incorporate it into nurses' practice to provide pain relief and augment the effects of other pain interventions. The aims of this proposal are to (1) examine the feasibility of providing a training course of APA for clinical oncology nurses which can integrate APA into real-world nursing care settings and (2) examine the effectiveness of APA on CRP under the usual conditions.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer-related Pain, Acupressure
Keywords
Auricular Point Acupressure, Cancer-related Pain, Acupressure, Nursing education

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
31 (Actual)

8. Arms, Groups, and Interventions

Arm Title
APA Treatment
Arm Type
Experimental
Arm Description
Oncology patients with a pain rating of four or greater will receive APA treatment for patients' cancer-related pain. The ear points will be determined by the corresponding body points related to the patient's specific pain. Pain data will be tracked by electronic surveys and Electronic Health Records.
Intervention Type
Other
Intervention Name(s)
APA Treatment
Intervention Description
Light touch using vaccaria seeds on corresponding ear points related to patient's pain.
Primary Outcome Measure Information:
Title
Change in Pain Intensity as assessed by the Brief Pain Inventory (BPI) short form
Description
Pain intensity in the last 24 hours (1) at its worst and (2) on average will both be measured on a scale of 0 (no pain) to 10 (pain as bad as you can imagine).
Time Frame
Baseline (pre-treatment), APA Intervention (one session, 1 day), Follow-up (3 consecutive days after treatment, starting the first day treatment is given).
Title
Change in Pain Interference as assessed by the Brief Pain Inventory (BPI) short form
Description
Pain interference with general activity, mood, walking ability, normal work, relationships with other people, sleep and enjoyment of life will be measured on a scale of 0 (does not interfere) to 10 (completely interferes).
Time Frame
Baseline (pre-treatment), APA Intervention (one session, 1 day), Follow-up (3 consecutive days after treatment, starting the first day treatment is given).
Title
Change in Dose of Analgesic Use
Description
Dose of analgesic use will be collected in electronic health record (EHR) as part of routine nursing assessments for patient care.
Time Frame
Baseline (pre-treatment), APA Intervention (one session, 1 day), Follow-up (3 consecutive days after treatment, starting the first day treatment is given).
Secondary Outcome Measure Information:
Title
Change in Fatigue as assessed by a 0 to 10 scale
Description
Fatigue will be measured on a scale of 0 (energetic, no fatigue) to 10 (worst possible fatigue).
Time Frame
Baseline (pre-treatment), APA Intervention (one session, 1 day), Follow-up (3 consecutive days after treatment, starting the first day treatment is given).
Title
Change in Quality of Sleep as assessed by a 0 to 10 scale
Description
Sleep quality will be measured on a scale of 0 (very poor) to 10 (very good).
Time Frame
Baseline (pre-treatment), APA Intervention (one session, 1 day), Follow-up (3 consecutive days after treatment, starting the first day treatment is given).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Cancer patients with worst pain rated as 4 or more on a 0-10 numeric rating scale in the last 24 hours, which will use the EPIC pain scale Able to read and write English Able to apply pressure to the seeds taped to the ears. Patients with any cancer type will be eligible for this study so long as the patients are experiencing cancer-related pain Owns a smartphone Exclusion Criteria: Is delirious Has ear skin disease Non-English speaker Has latex allergy to the tape used for this study Women who are pregnant
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chao Hsing Yeh, PhD
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21231
Country
United States

12. IPD Sharing Statement

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Integrating Auricular Point Acupressure Into Real-world Nursing Practice to Manage Cancer-related Pain

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