Breast Cancer Clinical Trial
Official title:
A Pilot Randomized Controlled Trial to Assess the Impact of Acupuncture on Post-mastectomy Pain, Nausea, Anxiety and Ability to Cope.
Verified date | September 2017 |
Source | Allina Health System |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 30 |
Est. completion date | January 2016 |
Est. primary completion date | December 2014 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Women - 18 years or older - Undergoing mastectomy surgery Exclusion Criteria: - Non-English speaking - Pregnant - Also undergoing an oophorectomy, TRAM or Latissimus flap surgery |
Country | Name | City | State |
---|---|---|---|
United States | Abbott Northwestern Hospital | Minneapolis | Minnesota |
Lead Sponsor | Collaborator |
---|---|
Allina Health System | Abbott Northwestern Hospital |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Change in Pain Post Intervention | Change in pain on a single question 11-point Numeric Rating Scale (NRS) where 0 equals no pain and 10 equals most severe pain. The score is derived by subtracting the pre-intervention score from the post-intervention score within the same day (e.g. Post-Pain Day 1 - Pre-Pain Day 1). A lower score indicates better outcomes. Outcomes were obtained on both post-op Day 1 and Day 2. | Participants will be followed on post operations day 1 and 2 of their hospital stay | |
Secondary | Change in Anxiety Post Intervention | Change in anxiety on a single question 11-point Numeric Rating Scale (NRS) where 0 equals no anxiety and 10 equals most severe anxiety. The score is derived by subtracting the pre-intervention score from the post-intervention score within the same day (e.g. Post-Anxiety Day 1 - Pre-Anxiety Day 1). A lower score indicates better outcomes. Outcomes were obtained on both post-op Day 1 and Day 2. | Participants will be followed on post operations day 1 and 2 of their hospital stay | |
Secondary | Change in Nausea Post Intervention | Change in nausea on a single question 11-point Numeric Rating Scale (NRS) where 0 equals no nausea and 10 equals most severe nausea. The score is derived by subtracting the pre-intervention score from the post-intervention score within the same day (e.g. Post-Nausea Day 1 - Pre-Nausea Day 1). A lower score indicates better outcomes. Outcomes were obtained on both post-op Day 1 and Day 2. | Participants will be followed on post operations day 1 and 2 of their hospital stay | |
Secondary | Change in Ability to Cope Post Intervention | Change in ability to cope on a single question 11-point Numeric Rating Scale (NRS) where 0 equals absence of an ability to cope and 10 equals complete ability to cope. The score is derived by subtracting the pre-intervention score from the post-intervention score within the same day (e.g. Post-Coping Day 1 - Pre-Coping Day 1). . A higher score indicates better outcomes. Outcomes were obtained on both post-op Day 1 and Day 2. | Participants will be followed on post operations day 1 and 2 of their hospital stay |
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