Development of an Informed Consent Statement Which Communicates the Risk of Adverse Events Associated With Dry Needling

NCT05560100 | Completed

• 1 other identifier: 2022-173
• Study Type: observational
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Dry Needling

Keywords

informed consent; adverse event; nominal group technique

Outcome Measures

Primary Outcomes (2)

• Demographic Information Form

  Contains questions about the characteristics of the participants

  Up to 2 hours

• Ranking of Statements

  Participants will rank statements generated during the meeting to determine which statement best meets consensus within the group

  A 2 hour virtual meeting for participants to rank statements

Study Arms (4)

Patients

Must have participated in \>= 1 session of dry needling treatment and not be a healthcare provider.

Other: Nominal Group Technique - 2 to 3 hour virtual meeting

Dry Needling Experts

(1) Must have \>= 5 years of clinical practice performing dry needling and at least ONE of the following secondary criteria: 1. Certification in Dry Needling 2. Completion of a manual therapy fellowship that included dry needling training 3. \>= 1 total scholarly product (poster presentation, author of a peer-reviewed publication) involving the use of dry needling

Other: Nominal Group Technique - 2 to 3 hour virtual meeting

Policy Experts

An individual who has a degree in bioethics with at least ONE of the following criteria: 1. \>= 5 years of experience in obtaining informed consent or an advanced graduate degree in bioethics 2. Has served on ethics related committee in a healthcare institution or healthcare society/professional association 3. Is or has been a member of a state licensing board

Other: Nominal Group Technique - 2 to 3 hour virtual meeting

Legal Experts

An individual who is an attorney and who has had training in health law as evidenced by at least ONE of the following criteria: 1. Evidence of training based on ONE of the follow: 1. Concentration/Certification in Health Law 2. L.L.M in health or medical law 3. SJD in health law 2. Experience in litigating medical malpractice cases involving failure to obtain informed consent 3. Published scholarship on informed consent in an academic journal (\>= 1)

Other: Nominal Group Technique - 2 to 3 hour virtual meeting

Interventions

Nominal Group Technique - 2 to 3 hour virtual meeting OTHER

Participants will be invited to a 2-3 online virtual online meeting with the goal of constructing and defining elements for producing a risk statement for dry needling that can be used for informed consent.

Dry Needling Experts; Legal Experts; Patients; Policy Experts

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Dry Needling Experts, Legal Experts, Policy Experts, and Patients (Defined with inclusion criteria above).

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:

Sponsors & Collaborators

• Youngstown State University: lead

Study Sites (1)

Youngstown State University

Youngstown, Ohio, 44555, United States

Location

Related Publications (2)

• Whitney SN, McGuire AL, McCullough LB. A typology of shared decision making, informed consent, and simple consent. Ann Intern Med. 2004 Jan 6;140(1):54-9. doi: 10.7326/0003-4819-140-1-200401060-00012.

  PMID: 14706973 BACKGROUND

• Ickert EC, Griswold D, Learman K, Cook C. Creation of a risk of harms informed consent form for dry needling: A nominal group technique. Musculoskelet Sci Pract. 2023 Aug;66:102778. doi: 10.1016/j.msksp.2023.102778. Epub 2023 May 24.

  PMID: 37290346 DERIVED

Study Officials

• Edmund C Ickert, PhD

  Youngstown State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2022
• First Posted: September 29, 2022
• Study Start: September 19, 2022
• Primary Completion: October 31, 2022
• Study Completion: October 31, 2022
• Last Updated: June 13, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)