MedPath

Acupuncture for Pre-Procedure Anxiety

Not Applicable
Terminated
Conditions
Anxiety
Interventions
Device: Shen Men acupuncture
Procedure: Epidural injection
Registration Number
NCT03480919
Lead Sponsor
Hospital for Special Surgery, New York
Brief Summary

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.

Detailed Description

Not available

Recruitment & Eligibility

Status
TERMINATED
Sex
All
Target Recruitment
4
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Shen Men acupunctureEpidural injectionSingle acupuncture needles will be placed bilaterally onto the patient's Shen Men acupuncture point in the ear for a duration of 20 minutes.
Shen Men acupunctureShen Men acupunctureSingle acupuncture needles will be placed bilaterally onto the patient's Shen Men acupuncture point in the ear for a duration of 20 minutes.
Sham acupunctureEpidural injectionSingle acupuncture needles will be placed bilaterally onto a sham location in the ear for a duration of 20 minutes.
Simulated acupunctureEpidural injectionAcupuncture will be simulated with a paper clip.
Primary Outcome Measures
NameTimeMethod
AnxietyUp 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 (STAI). The STAI is a psychological inventory based on a 4-point Likert scale and consists of 40 questions on a self-report basis. The STAI is one of the first tests to assess both state and trait anxiety separately. Each type of anxiety has its own scale of 20 different questions that are scored. Scores range from 20 to 80, with higher scores correlating with greater anxiety. Low scores indicate a mild form of anxiety whereas median scores indicate a moderate form of anxiety and high scores indicate a severe form of anxiety. The 4-point scale for S-anxiety is as follows: 1.) not at all, 2.) somewhat, 3.) moderately so, 4.) very much so. The 4-point scale for T-anxiety is as follows: 1.) almost never, 2.) sometimes, 3.) often, 4.) almost always.

Secondary Outcome Measures
NameTimeMethod
Anxiety Medication UseUp to 30 min post-acupuncture intervention.

Any use of medication use following the acupuncture intervention and before the epidural injection will be documented.

Belief of AcupunctureUp 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)

Trial Locations

Locations (1)

Hospital for Special Surgery

🇺🇸

New York, New York, United States

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