Viewing Study NCT02122796



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Last Modification Date: 2024-10-26 @ 11:23 AM
Study NCT ID: NCT02122796
Status: COMPLETED
Last Update Posted: 2018-04-02
First Post: 2014-04-16

Brief Title: A Pilot Trial to Assess the Impact of Acupuncture on Post-mastectomy Pain Nausea Anxiety and Ability to Cope
Sponsor: Allina Health System
Organization: Allina Health System

Study Overview

Official Title: A Pilot Randomized Controlled Trial to Assess the Impact of Acupuncture on Post-mastectomy Pain Nausea Anxiety and Ability to Cope
Status: COMPLETED
Status Verified Date: 2017-09
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None