Development of an Informed Consent Statement Which Communicates the Risk of Adverse Events Associated With Dry Needling
Completed
Conditions studied: Dry Needling
In brief
As Dry Needling (DN) continues to see increased use in the clinic, there is a need to establish adverse events that could occur as a result of DN intervention. The adverse events are important to consider when an individual needs to make an informed decision regarding their care. It is important to consider how such information should be presented during the informed consent process to improve an individual's ability to make a sound decision regarding their own personal care.
Key facts
- Study ID
- NCT05560100
- Run by
- Youngstown State University
- People needed
- 5
- Starts
- 2022-09-19
- Expected to finish
- 2022-10-31
- Last updated by the study team
- 2023-06-13
Who can join
Age: 18 and older, up to 100. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Participants must be 18 years old or above and be able to read/write in English Participants must provide informed consent Participants must meet the criteria of one of the previously defined cohort groups used in the study
- Dry Needling Experts
- (1) Must have >= 5 years of clinical practice performing dry needling and at least ONE of the following secondary criteria:
- Certification in Dry Needling
- Completion of a manual therapy fellowship that included dry needling training
- >= 1 total scholarly product (poster presentation, author of a peer-reviewed publication) involving the use of dry needling
- Legal Expert
- An individual who is an attorney and who has had training in health law as evidenced by at least ONE of the following criteria:
- Training in health law as evidenced by ONE of the following:
- Concentration/Certification in Health Law
- L.L.M in health or medical law
- SJD in health law
- Experience in litigating medical malpractice cases involving failure to obtain informed consent
- Published scholarship on informed consent in an academic journal (>= 1) Policy Expert
- An individual who has a degree in bioethics with at least ONE of the following criteria:
- >= 5 years of experience in obtaining informed consent or an advanced graduate degree in bioethics
- Has served on ethics related committee in a healthcare institution or healthcare society/professional association
- Is or has been a member of a state licensing board
- Patient Must have participated in >= 1 session of dry needling treatment and not be a healthcare provider
You may not qualify if…
- Participants who did not provide informed consent Participants who did not meet the inclusion criteria of one of the four cohort groups defined in the study.
Where it is running
- Youngstown State University — Youngstown, Ohio, United States
Full record on ClinicalTrials.gov
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