A Pilot Randomized Controlled Trial to Assess the Impact of Acupuncture on Post-mastectomy Pain, Nausea, Anxiety and Ability to Cope.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Breast Cancer
- Sponsor
- Allina Health System
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Number of Patients Eligible Compared to the Number Approached and Enrolled
- Status
- Completed
- Last Updated
- 8 years ago
Overview
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.
Detailed Description
About 40 subjects will be participating in this study. Following qualification for the study, participants will be randomly assigned by chance to receive either acupuncture or to receive the standard of care without an integrative medicine session. * One group will receive acupuncture after surgery. Acupuncture involves inserting thin, sterile needles at certain points on your body. * The other group will receive the standard of care without an acupuncture session. Before surgery participants will complete a demographics questionnaire. After surgery, participants will be visited in their hospital room by either an acupuncturist or another member of the research team. For those assigned to the acupuncture group, participants will receive up to two sessions of acupuncture, at least twelve hours apart. For those assigned to the control group, a research team member will visit the participant in their room up to two times, at least twelve hours apart. During those visits, participants will be asked about pain, nausea, anxiety, and ability to cope at the beginning and end of each treatment or visit. Additional information will be gathered from participants hospital charts, such as the type of surgery that was performed, length of hospital stay, and the costs associated with the hospital stay.
Investigators
Eligibility Criteria
Inclusion Criteria
- •18 years or older
- •Undergoing mastectomy surgery
Exclusion Criteria
- •Non-English speaking
- •Also undergoing an oophorectomy, TRAM or Latissimus flap surgery
Outcomes
Primary Outcomes
Number of Patients Eligible Compared to the Number Approached and Enrolled
Time Frame: One year
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.
Secondary Outcomes
- 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)