Back to resultsPeri-procedural Smoking Cessation Program in Patients With Chronic Pain
Primary Purpose
Chronic Pain, Smoking
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Smoking cessation counseling
Sponsored by
About this trial
This is an interventional other trial for Chronic Pain
Eligibility Criteria
Inclusion Criteria:
- Chronic Pain of 3 months or greater
- Scheduled for interventional pain procedure
Exclusion Criteria:
- Cancer related pain
- Current participation in smoking abstinence program
- History of schizophrenia or other pyschotic disorder
- History of dementing illness
- Pregnant patients
- Diagnosis of depression or anxiety
Sites / Locations
- Cooper University Hospital
Outcomes
Primary Outcome Measures
Pain
Visual analogue pain score
Secondary Outcome Measures
Full Information
NCT ID
NCT04605744
First Posted
October 22, 2020
Last Updated
January 11, 2022
Sponsor
The Cooper Health System
1. Study Identification
Unique Protocol Identification Number
NCT04605744
Brief Title
Peri-procedural Smoking Cessation Program in Patients With Chronic Pain
Official Title
Implementation of a Peri-procedural Smoking Cessation Program in Patients With Chronic Pain Undergoing Interventional Pain Management Procedures
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Terminated
Why Stopped
the investigators were unable to recruit a sufficient number of participants
Study Start Date
February 18, 2020 (Actual)
Primary Completion Date
December 6, 2021 (Actual)
Study Completion Date
December 6, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Cooper Health System
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
This single arm study will assess whether smoking cessation counseling offered to chronic pain patients is effective in reducing pain and cigarette use.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain, Smoking
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
11 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
Smoking cessation counseling
Intervention Description
Patients will be given a briefing on the benefits of smoking cessation in the peri-procedural period around their interventional pain procedure. They will also be provided an informational sheet from the American Society of Anesthesiologists promoting cessation. The sheet will contain the 1-800-QUITNOW national hotline phone number.
Additional an enrollment folder will provided that contains referral information to Cooper's Tobacco Cessation program. This service, free of charge to Cooper Health patients consists of 5 tobacco cessation counselors who use personalized cessation plans, individual and group counseling cessations, Chantix, and education to promote smoking cessation.
Primary Outcome Measure Information:
Title
Pain
Description
Visual analogue pain score
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Chronic Pain of 3 months or greater
Scheduled for interventional pain procedure
Exclusion Criteria:
Cancer related pain
Current participation in smoking abstinence program
History of schizophrenia or other pyschotic disorder
History of dementing illness
Pregnant patients
Diagnosis of depression or anxiety
Facility Information:
Facility Name
Cooper University Hospital
City
Camden
State/Province
New Jersey
ZIP/Postal Code
08103
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Peri-procedural Smoking Cessation Program in Patients With Chronic Pain
We'll reach out to this number within 24 hrs