- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03245034
Assessing the Impact of Acupuncture Therapy on Medical Resident Well-Being: Feasibility and Acceptance
October 6, 2017 updated by: NYU Langone Health
This feasibility study develops methods for larger-scale research, evaluating the acceptability and perceived impact of a group acupuncture and acupressure intervention, as well as suitability of a self-report instrument.
During their weekly training program, eleven OB residents at NYU Lutheran Medical Center will receive three sessions of auricular acupuncture therapy.
(This resident population was previously anonymously surveyed and all expressed interest in participating in such a study).
The Professional Quality of Life Scale (ProQOL) will be administered at 6 time points.
A brief survey will also be given to assess participants' acceptance of the intervention as well as applicability of the ProQOL instrument.
Additional feasibility-related outcomes include protocol compliance/withdrawals, adverse events, and time taken to complete intervention and surveys.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
12
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New York
-
New York, New York, United States, 10016
- New York University School of Medicine
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
25 years to 44 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Enrollment in NYU Lutheran Obstetrics & Gynecology Residency program
Exclusion Criteria:
- Women currently pregnant or attempting to conceive
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: fourth-year Obstetrics and Gynecology residents
The intervention will be three sessions of auricular acupuncture therapy; there will be no control intervention.
|
Acupuncture treatment will be the NADA protocol, a well-known and commonly used protocol that has previously been studied for stress relief in health care workers.In this protocol, 5, ½" needles are inserted in each auricle and retained while the group relaxes for 20 minutes.
It will be conducted by two acupuncturists credentialed at NYU Lutheran (TK and AG).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Professional Quality of Life (ProQOL)
Time Frame: 4 Weeks
|
he ProQOL is the most commonly used measure of the negative and positive affects of helping others who experience suffering and trauma.
The ProQOL has sub-scales for compassion satisfaction, burnout and compassion fatigue.
|
4 Weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Meera Kesavan, MD, NYU Langone Health
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 1, 2017
Primary Completion (Actual)
September 1, 2017
Study Completion (Actual)
September 1, 2017
Study Registration Dates
First Submitted
August 7, 2017
First Submitted That Met QC Criteria
August 7, 2017
First Posted (Actual)
August 10, 2017
Study Record Updates
Last Update Posted (Actual)
October 9, 2017
Last Update Submitted That Met QC Criteria
October 6, 2017
Last Verified
October 1, 2017
More Information
Terms related to this study
Other Study ID Numbers
- 16-02292
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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