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Acupuncture for Pre-Procedure Anxiety

Primary Purpose

Anxiety

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Shen Men acupuncture
Epidural injection
Sponsored by
Hospital for Special Surgery, New York
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anxiety

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital for Special Surgery

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Sham Comparator

Placebo Comparator

Arm Label

Shen Men acupuncture

Sham acupuncture

Simulated acupuncture

Arm Description

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

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

Acupuncture will be simulated with a paper clip.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
March 20, 2018
Last Updated
November 8, 2019
Sponsor
Hospital for Special Surgery, New York
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1. Study Identification

Unique Protocol Identification Number
NCT03480919
Brief Title
Acupuncture for Pre-Procedure Anxiety
Official Title
Shen Men Acupuncture for Anxiety Preceding Lumbar Epidural Injections in Acupuncture-naive Patients: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Terminated
Why Stopped
Limited resources
Study Start Date
March 20, 2018 (Actual)
Primary Completion Date
July 31, 2018 (Actual)
Study Completion Date
July 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital for Special Surgery, New York

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
4 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Shen Men acupuncture
Arm Type
Experimental
Arm Description
Single acupuncture needles will be placed bilaterally onto the patient's Shen Men acupuncture point in the ear for a duration of 20 minutes.
Arm Title
Sham acupuncture
Arm Type
Sham Comparator
Arm Description
Single acupuncture needles will be placed bilaterally onto a sham location in the ear for a duration of 20 minutes.
Arm Title
Simulated acupuncture
Arm Type
Placebo Comparator
Arm Description
Acupuncture will be simulated with a paper clip.
Intervention Type
Device
Intervention Name(s)
Shen Men acupuncture
Intervention Description
20-minute acupuncture session
Intervention Type
Procedure
Intervention Name(s)
Epidural injection
Intervention Description
Epidural injection for the relief of back pain
Primary Outcome Measure Information:
Title
Anxiety
Description
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.
Time Frame
Up to 30 min post-acupuncture intervention
Secondary Outcome Measure Information:
Title
Belief of Acupuncture
Description
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)
Time Frame
Up to 30 min post-acupuncture intervention
Title
Anxiety Medication Use
Description
Any use of medication use following the acupuncture intervention and before the epidural injection will be documented.
Time Frame
Up to 30 min post-acupuncture intervention.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Hospital for Special Surgery
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States

12. IPD Sharing Statement

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Acupuncture for Pre-Procedure Anxiety

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