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Trial Outcomes & Findings for Acupuncture for Pre-Procedure Anxiety (NCT NCT03480919)

NCT ID: NCT03480919

Last Updated: 2019-11-12

Results Overview

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.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

4 participants

Primary outcome timeframe

Up to 30 min post-acupuncture intervention

Results posted on

2019-11-12

Participant Flow

Participant milestones

Participant milestones
Measure
Shen Men Acupuncture
Single 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 acupuncture: 20-minute acupuncture session Epidural injection: Epidural injection for the relief of back pain
Sham Acupuncture
Single acupuncture needles will be placed bilaterally onto a sham location in the ear for a duration of 20 minutes. Epidural injection: Epidural injection for the relief of back pain
Simulated Acupuncture
Acupuncture will be simulated with a paper clip. Epidural injection: Epidural injection for the relief of back pain
Overall Study
STARTED
1
2
1
Overall Study
COMPLETED
1
2
1
Overall Study
NOT COMPLETED
0
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Acupuncture for Pre-Procedure Anxiety

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Shen Men Acupuncture
n=1 Participants
Single 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 acupuncture: 20-minute acupuncture session Epidural injection: Epidural injection for the relief of back pain
Sham Acupuncture
n=2 Participants
Single acupuncture needles will be placed bilaterally onto a sham location in the ear for a duration of 20 minutes. Epidural injection: Epidural injection for the relief of back pain
Simulated Acupuncture
n=1 Participants
Acupuncture will be simulated with a paper clip. Epidural injection: Epidural injection for the relief of back pain
Total
n=4 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
Age, Categorical
Between 18 and 65 years
1 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
1 Participants
n=4 Participants
Age, Categorical
>=65 years
0 Participants
n=5 Participants
2 Participants
n=7 Participants
1 Participants
n=5 Participants
3 Participants
n=4 Participants
Age, Continuous
36 years
STANDARD_DEVIATION 0 • n=5 Participants
65 years
STANDARD_DEVIATION 0 • n=7 Participants
87 years
STANDARD_DEVIATION 0 • n=5 Participants
63 years
STANDARD_DEVIATION 21 • n=4 Participants
Sex: Female, Male
Female
0 Participants
n=5 Participants
2 Participants
n=7 Participants
1 Participants
n=5 Participants
3 Participants
n=4 Participants
Sex: Female, Male
Male
1 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
1 Participants
n=4 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants
n=5 Participants
1 Participants
n=7 Participants
0 Participants
n=5 Participants
1 Participants
n=4 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
1 Participants
n=5 Participants
1 Participants
n=7 Participants
1 Participants
n=5 Participants
3 Participants
n=4 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
Region of Enrollment
United States
1 participants
n=5 Participants
2 participants
n=7 Participants
1 participants
n=5 Participants
4 participants
n=4 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Shen Men Acupuncture
n=1 Participants
Single 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 acupuncture: 20-minute acupuncture session Epidural injection: Epidural injection for the relief of back pain
Sham Acupuncture
n=2 Participants
Single acupuncture needles will be placed bilaterally onto a sham location in the ear for a duration of 20 minutes. Epidural injection: Epidural injection for the relief of back pain
Simulated Acupuncture
n=1 Participants
Acupuncture will be simulated with a paper clip. Epidural injection: Epidural injection for the relief of back pain
Anxiety
0 score on a scale
Standard Deviation 0
0.2 score on a scale
Standard Deviation 4.5
-6 score on a scale
Standard Deviation 0

SECONDARY outcome

Timeframe: 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)

Outcome measures

Outcome measures
Measure
Shen Men Acupuncture
n=1 Participants
Single 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 acupuncture: 20-minute acupuncture session Epidural injection: Epidural injection for the relief of back pain
Sham Acupuncture
n=2 Participants
Single acupuncture needles will be placed bilaterally onto a sham location in the ear for a duration of 20 minutes. Epidural injection: Epidural injection for the relief of back pain
Simulated Acupuncture
n=1 Participants
Acupuncture will be simulated with a paper clip. Epidural injection: Epidural injection for the relief of back pain
Belief of Acupuncture
8 units on a scale
Standard Deviation 0
8 units on a scale
Standard Deviation 4
7 units on a scale
Standard Deviation 0

SECONDARY outcome

Timeframe: Up to 30 min post-acupuncture intervention.

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

Outcome measures

Outcome measures
Measure
Shen Men Acupuncture
n=1 Participants
Single 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 acupuncture: 20-minute acupuncture session Epidural injection: Epidural injection for the relief of back pain
Sham Acupuncture
n=2 Participants
Single acupuncture needles will be placed bilaterally onto a sham location in the ear for a duration of 20 minutes. Epidural injection: Epidural injection for the relief of back pain
Simulated Acupuncture
n=1 Participants
Acupuncture will be simulated with a paper clip. Epidural injection: Epidural injection for the relief of back pain
Anxiety Medication Use
0 Participants
0 Participants
0 Participants

Adverse Events

Shen Men Acupuncture

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Sham Acupuncture

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Simulated Acupuncture

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Jonathan Kirschner

Hospital for Special Surgery

Phone: 6467146327

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place