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Acupuncture for Pre-Procedure Anxiety

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ClinicalTrials.gov Identifier: NCT03480919
Recruitment Status : Recruiting
First Posted : March 29, 2018
Last Update Posted : April 20, 2018
Sponsor:
Information provided by (Responsible Party):
Hospital for Special Surgery, New York

March 20, 2018
March 29, 2018
April 20, 2018
March 20, 2018
July 31, 2018   (Final data collection date for primary outcome measure)
Anxiety [ Time Frame: Up to 30 min post-acupuncture intervention ]
Change in anxiety from baseline (pre-acupuncture intervention) will be measured using the State subscale of the State Trait Anxiety Inventory.
Same as current
Complete list of historical versions of study NCT03480919 on ClinicalTrials.gov Archive Site
  • Belief of acupuncture [ Time Frame: Up to 30 min post-acupuncture intervention ]
    Patients will be asked "On a scale of 0-10, how much do you believe acupuncture to be a valid treatment for anxiety?" (0=do not believe at all; 10=fully believe)
  • Anxiety medication use [ Time Frame: Up to 30 min post-acupuncture intervention. ]
    Any use of medication use following the acupuncture intervention and before the epidural injection will be documented.
Same as current
Not Provided
Not Provided
 
Acupuncture for Pre-Procedure Anxiety
Shen Men Acupuncture for Anxiety Preceding Lumbar Epidural Injections in Acupuncture-naive Patients: a Randomized Controlled Trial
It is common for patients undergoing spinal injections to report anxiety prior to the injection. Although sedation, general anesthesia, and medications can be used to reduce anxiety, the use of sedative agents during the procedure can increase the risk of spinal cord injury. The purpose of this study is to see if receiving acupuncture before a spinal injection can effectively reduce patients' anxiety. Only patients who are scheduled to receive a spinal injection at this institution will be eligible for the study.
Not Provided
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Anxiety
  • Device: Shen Men acupuncture
    20-minute acupuncture session
  • Procedure: Epidural injection
    Epidural injection for the relief of back pain
  • Experimental: Shen Men acupuncture
    Single acupuncture needles will be placed bilaterally onto the patient's Shen Men acupuncture point in the ear for a duration of 20 minutes.
    Interventions:
    • Device: Shen Men acupuncture
    • Procedure: Epidural injection
  • Sham Comparator: Sham acupuncture
    Single acupuncture needles will be placed bilaterally onto a sham location in the ear for a duration of 20 minutes.
    Intervention: Procedure: Epidural injection
  • Placebo Comparator: Simulated acupuncture
    Acupuncture will be simulated with a paper clip.
    Intervention: Procedure: Epidural injection
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
99
Same as current
July 31, 2018
July 31, 2018   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age 18+
  • Spine pathology that meets criteria for lumbar epidural injection

Exclusion Criteria:

  • Unable to provide consent
  • Contraindications to acupuncture (e.g., rash, skin infection, sensory loss in ear)
  • Previous experience of acupuncture
  • Age <18
  • Pregnant women
  • Non-English or Non-Spanish speaking
Sexes Eligible for Study: All
18 Years to 100 Years   (Adult, Older Adult)
No
Contact: Jennifer Cheng 6467146870 chengj@hss.edu
United States
 
 
NCT03480919
2017-1525
Not Provided
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Product Manufactured in and Exported from the U.S.: No
Not Provided
Hospital for Special Surgery, New York
Hospital for Special Surgery, New York
Not Provided
Not Provided
Hospital for Special Surgery, New York
April 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP