Exhaustion; SyndromeNCT03245034
Assessing the Impact of Acupuncture Therapy on Medical Resident Well-Being: Feasibility and Acceptance
A study testing Auricular Acupuncture Therapy in people with Exhaustion; Syndrome, run by NYU Langone Health at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 25 to 44 yearsHealthy volunteers can take part
- Conditions the study is for
- Exhaustion; Syndrome
- What is being tested?
- Auricular Acupuncture Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2017to 1 Sep 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 44 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Enrollment in NYU Lutheran Obstetrics \& Gynecology Residency program
Who cannot join
- Women currently pregnant or attempting to conceive
Trial locations and contacts
1 site in 1 country.
United States1 site
New York University School of Medicine
New York, New York, 10016
About this study
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.
- Conditions
- Exhaustion; Syndrome
- Being tested
- Auricular Acupuncture Therapy
- Keywords
- Medical Residents, Well-Being, Stress/Burnout in Medical Residents
- Medical subject headings
- Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Auricular Acupuncture TherapyBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| fourth-year Obstetrics and Gynecology residents | Experimental | The intervention will be three sessions of auricular acupuncture therapy; there will be no control intervention. Receives: Behavioral: Auricular Acupuncture Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Professional Quality of Life (ProQOL)
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.
Measured: 4 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2017
- Study start1 Jun 2017
- Primary completion1 Sep 2017
- Study completion1 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Exhaustion; SyndromeStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Meera Kesavan, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03245034
- Sponsor's protocol ID
- 16-02292
- Status last verified
- Oct 2017
- First submitted
- 7 Aug 2017
- Last updated
- 9 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Impact of Acupuncture Therapy on Medical Resident Well-Being: Feasibility and Acceptance
- ClinicalTrials.gov ID
- NCT03245034
- Acronym / sponsor ID
- 16-02292
- Conditions
- Exhaustion; Syndrome
- Keywords
- Medical Residents, Well-Being, Stress/Burnout in Medical Residents
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 1 Sep 2017 (actual)
- Study completion
- 1 Sep 2017 (actual)
- First posted
- 10 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| fourth-year Obstetrics and Gynecology residents | Experimental | Behavioral: Auricular Acupuncture TherapyThe intervention will be three sessions of auricular acupuncture therapy; there will be no control intervention. |
Who may qualify
- Ages
- 25 to 44 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Enrollment in NYU Lutheran Obstetrics \& Gynecology Residency program
Key exclusion criteria (1 listed)
- Women currently pregnant or attempting to conceive
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Auricular Acupuncture TherapyAcupuncture 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). | Behavioural | fourth-year Obstetrics and Gynecology residents |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2017.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Meera Kesavan, MD principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Auricular Acupuncture Therapy in people with Exhaustion; Syndrome, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Professional Quality of Life (ProQOL) (time frame: 4 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2017.