Acupuncture for Pre-Procedure Anxiety

NCT03480919 | Terminated Results FDA Device

• 1 other identifier: 2017-1525
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Belief of Acupuncture

  Up to 30 min post-acupuncture intervention

• Anxiety Medication Use

  Up to 30 min post-acupuncture intervention.

Study Arms (3)

Shen Men acupuncture

EXPERIMENTAL

Single acupuncture needles will be placed bilaterally onto the patient's Shen Men acupuncture point in the ear for a duration of 20 minutes.

Device: Shen Men acupuncture; Procedure: Epidural injection

Sham acupuncture

SHAM COMPARATOR

Single acupuncture needles will be placed bilaterally onto a sham location in the ear for a duration of 20 minutes.

Procedure: Epidural injection

Simulated acupuncture

PLACEBO COMPARATOR

Acupuncture will be simulated with a paper clip.

Procedure: Epidural injection

Interventions

Shen Men acupuncture DEVICE

20-minute acupuncture session

Shen Men acupuncture

Epidural injection PROCEDURE

Epidural injection for the relief of back pain

Sham acupuncture; Shen Men acupuncture; Simulated acupuncture

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital for Special Surgery, New York: lead

Study Sites (1)

Hospital for Special Surgery

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Injections, Epidural

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Injections, Spinal; Injections; Drug Administration Routes; Drug Therapy; Therapeutics

Results Point of Contact

• Title: Jonathan Kirschner
• Organization: Hospital for Special Surgery

kirschnerj@hss.edu

6467146327

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2018
• First Posted: March 29, 2018
• Study Start: March 20, 2018
• Primary Completion: July 31, 2018
• Study Completion: July 31, 2018
• Last Updated: November 12, 2019
• Results First Posted: October 1, 2019

Record last verified: 2019-11

Locations

US (1)