Acupuncture for Pre-Procedure Anxiety

NCT ID: NCT03480919

Last Updated: 2019-11-12

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-20

Study Completion Date

2018-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Anxiety

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Shen Men acupuncture

Intervention Type DEVICE

20-minute acupuncture session

Epidural injection

Intervention Type PROCEDURE

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.

Group Type SHAM_COMPARATOR

Epidural injection

Intervention Type PROCEDURE

Epidural injection for the relief of back pain

Simulated acupuncture

Acupuncture will be simulated with a paper clip.

Group Type PLACEBO_COMPARATOR

Epidural injection

Intervention Type PROCEDURE

Epidural injection for the relief of back pain

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Shen Men acupuncture

20-minute acupuncture session

Intervention Type DEVICE

Epidural injection

Epidural injection for the relief of back pain

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Hospital for Special Surgery, New York

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Hospital for Special Surgery

New York, New York, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2017-1525

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.