Acupuncture for Pre-Procedure Anxiety

Not Applicable

Terminated

• Conditions: Anxiety

• 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

Study Timeline

• Study Start: 2018-03-20
• Study First Submitted: 2018-03-20
• Study First Submitted QC: 2018-03-26
• Study First Posted: 2018-03-29
• Primary Completion: 2018-07-31
• Study Completion: 2018-07-31
• Results First Submitted: 2019-09-06
• Results First Submitted QC: 2019-09-06
• Results First Posted: 2019-10-01
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-08
• Last Update Posted: 2019-11-12

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

Primary Outcome Measures

Name	Time	Method
Anxiety	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 (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

Name	Time	Method
Anxiety Medication Use	Up 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 Acupuncture	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)

Trial Locations

Locations (1)

Hospital for Special Surgery; 🇺🇸 New York, New York, United States