A Pilot Trial to Assess the Impact of Acupuncture on Post-mastectomy Pain, Nausea, Anxiety and Ability to Cope
A Pilot Randomized Controlled Trial to Assess the Impact of Acupuncture on Post-mastectomy Pain, Nausea, Anxiety and Ability to Cope.
1 other identifier
interventional
30
1 country
1
Brief Summary
The purpose of the study is to compare the effect of acupuncture to the standard of care (control group) on pain, nausea, anxiety, ability to cope, costs and length of hospital stay in post-mastectomy patients at Abbott Northwestern Hospital.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable breast-cancer
Started Jun 2014
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
April 16, 2014
CompletedFirst Posted
Study publicly available on registry
April 25, 2014
CompletedStudy Start
First participant enrolled
June 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2016
CompletedResults Posted
Study results publicly available
April 2, 2018
CompletedApril 2, 2018
September 1, 2017
6 months
April 16, 2014
August 31, 2016
September 6, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Patients Eligible Compared to the Number Approached and Enrolled
Feasibility will be measured by the number of patients eligible for enrollment, the number approached, the number consented, and the final sample with completed data. The study population will be described in terms of demographics and background characteristics collected on the enrollment questionnaire.
One year
Secondary Outcomes (4)
Change in Pain Post Intervention
Participants will be followed on post operations day 1 and 2 of their hospital stay
Change in Anxiety Post Intervention
Participants will be followed on post operations day 1 and 2 of their hospital stay
Change in Nausea Post Intervention
Participants will be followed on post operations day 1 and 2 of their hospital stay
Change in Ability to Cope Post Intervention
Participants will be followed on post operations day 1 and 2 of their hospital stay
Study Arms (2)
Acupuncture
EXPERIMENTALTwo sessions of acupuncture, at least twelve hours apart, post-mastectomy.
Standard of Care
NO INTERVENTIONStandard of care post-mastectomy.
Interventions
Acupuncture involves inserting thin, sterile needles into the skin at certain points in the body.
Eligibility Criteria
You may qualify if:
- Women
- years or older
- Undergoing mastectomy surgery
You may not qualify if:
- Non-English speaking
- Pregnant
- Also undergoing an oophorectomy, TRAM or Latissimus flap surgery
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Abbott Northwestern Hospital
Minneapolis, Minnesota, 55407, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Director of Integrative Health Reseach Center
- Organization
- Allina Health
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 16, 2014
First Posted
April 25, 2014
Study Start
June 1, 2014
Primary Completion
December 1, 2014
Study Completion
January 1, 2016
Last Updated
April 2, 2018
Results First Posted
April 2, 2018
Record last verified: 2017-09