Study Stopped
Due to Covid 19.
Integrating Auricular Point Acupressure Into Real-world Nursing Practice to Manage Cancer-related Pain
1 other identifier
interventional
31
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 30, 2019
CompletedFirst Posted
Study publicly available on registry
July 31, 2019
CompletedStudy Start
First participant enrolled
October 8, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
January 30, 2021
CompletedAugust 13, 2021
August 1, 2021
1.3 years
July 30, 2019
August 6, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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).
Baseline (pre-treatment), APA Intervention (one session, 1 day), Follow-up (3 consecutive days after treatment, starting the first day treatment is given).
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).
Baseline (pre-treatment), APA Intervention (one session, 1 day), Follow-up (3 consecutive days after treatment, starting the first day treatment is given).
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.
Baseline (pre-treatment), APA Intervention (one session, 1 day), Follow-up (3 consecutive days after treatment, starting the first day treatment is given).
Secondary Outcomes (2)
Change in Fatigue as assessed by a 0 to 10 scale
Baseline (pre-treatment), APA Intervention (one session, 1 day), Follow-up (3 consecutive days after treatment, starting the first day treatment is given).
Change in Quality of Sleep as assessed by a 0 to 10 scale
Baseline (pre-treatment), APA Intervention (one session, 1 day), Follow-up (3 consecutive days after treatment, starting the first day treatment is given).
Study Arms (1)
APA Treatment
EXPERIMENTALOncology 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.
Interventions
Light touch using vaccaria seeds on corresponding ear points related to patient's pain.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Is delirious
- Has ear skin disease
- Non-English speaker
- Has latex allergy to the tape used for this study
- Women who are pregnant
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21231, United States
Related Publications (1)
Van de Castle B, Lukkahatai N, Billing BL, Huang X, Wu H, Zhang J, Abdi S, Kameoka J, Smith TJ. Nurse-Administered Auricular Point Acupressure for Cancer-Related Pain. Integr Cancer Ther. 2023 Jan-Dec;22:15347354231198086. doi: 10.1177/15347354231198086.
PMID: 37706457DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Chao Hsing Yeh, PhD
Johns Hopkins University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 30, 2019
First Posted
July 31, 2019
Study Start
October 8, 2019
Primary Completion
January 30, 2021
Study Completion
January 30, 2021
Last Updated
August 13, 2021
Record last verified: 2021-08