Acupuncture for Pre-Procedure Anxiety

Anxiety Clinical Trial

Official title:

Shen Men Acupuncture for Anxiety Preceding Lumbar Epidural Injections in Acupuncture-naive Patients: a Randomized Controlled Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03480919
• Other study ID #: 2017-1525
• Status: Terminated
• Phase: N/A
• Start date: March 20, 2018
• Est. completion date: July 31, 2018

Study information

• Verified date: November 2019
• Source: Hospital for Special Surgery, New York
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: July 31, 2018
• Est. primary completion date: July 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders

Intervention

Device:
• Shen Men acupuncture
20-minute acupuncture session

Procedure:
• Epidural injection
Epidural injection for the relief of back pain

Locations

Country	Name	City	State
United States	Hospital for Special Surgery	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Hospital for Special Surgery, New York

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anxiety	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.	Up to 30 min post-acupuncture intervention
Secondary	Belief of Acupuncture	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)	Up to 30 min post-acupuncture intervention
Secondary	Anxiety Medication Use	Any use of medication use following the acupuncture intervention and before the epidural injection will be documented.	Up to 30 min post-acupuncture intervention.