Back to resultsThe Effectiveness of Information and Relaxation on Pre-procedural Block Anxiety and Procedural Discomfort During Medial Branch Block (TIRAP)
Primary Purpose
Chronic Pain
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Relaxation and information session
Sponsored by
About this trial
This is an interventional supportive care trial for Chronic Pain focused on measuring chronic pain, anxiety, intervention, information, relaxation
Eligibility Criteria
Inclusion Criteria:
- patient scheduled to have a medial branch block
- over 18 years of age
Exclusion Criteria:
- adult able to give their own consent
- patients who had a previous nerve block
- patients who have a major psychiatric illness
- patients who do not understand English or French
Sites / Locations
- MUHC, Montreal General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
information and relaxation
No intervention
Arm Description
will receive the intervention that consist of information and relaxation
No specific intervention before the medial branch block.
Outcomes
Primary Outcome Measures
Change in the anxiety level prior to the nerve block as per the state trait anxiety questionnaire
Secondary Outcome Measures
Perceived pain as measured by NRS (numerical rating scale)
Unchanged catastrophization level
Satisfaction level of the overall experience
Ease of performing the nerve block
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00901082
Brief Title
The Effectiveness of Information and Relaxation on Pre-procedural Block Anxiety and Procedural Discomfort During Medial Branch Block
Acronym
TIRAP
Official Title
The Effectiveness of Information and Relaxation on Pre-procedural Block Anxiety and Procedural Discomfort During Medial Branch Block: a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
April 2009 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
February 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Louise Lamb
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Patient presenting to chronic pain clinics frequently undergo diagnostic and therapeutic spinal injections as part of their treatment. These procedures can cause significant level of apprehension in patients, which can lead to increased procedural times, increased procedural pain and reluctance to continue with the treatment program. It appears that certain interventions could reduce the anxiety and catastrophization levels and modify pain perception during medical procedures. The investigators therefore sought to evaluate the effect of a single 30 minutes information session which includes relaxation training administered 5 to 6 days before the nerve block procedure on patient's anxiety and catastrophization levels prior to the procedure and pain scores during the procedure, as well as the overall level of satisfaction with care received.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain
Keywords
chronic pain, anxiety, intervention, information, relaxation
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
information and relaxation
Arm Type
Active Comparator
Arm Description
will receive the intervention that consist of information and relaxation
Arm Title
No intervention
Arm Type
No Intervention
Arm Description
No specific intervention before the medial branch block.
Intervention Type
Behavioral
Intervention Name(s)
Relaxation and information session
Intervention Description
Relaxation and information session before the medial branch block
Primary Outcome Measure Information:
Title
Change in the anxiety level prior to the nerve block as per the state trait anxiety questionnaire
Time Frame
5-7 days (Second visit and Day of block)
Secondary Outcome Measure Information:
Title
Perceived pain as measured by NRS (numerical rating scale)
Time Frame
Throughout the study (Baseline, day of block and 1 month after)
Title
Unchanged catastrophization level
Time Frame
Baseline and day of block
Title
Satisfaction level of the overall experience
Time Frame
Day after the block
Title
Ease of performing the nerve block
Time Frame
Day of block
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patient scheduled to have a medial branch block
over 18 years of age
Exclusion Criteria:
adult able to give their own consent
patients who had a previous nerve block
patients who have a major psychiatric illness
patients who do not understand English or French
Facility Information:
Facility Name
MUHC, Montreal General Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3G 1A4
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
The Effectiveness of Information and Relaxation on Pre-procedural Block Anxiety and Procedural Discomfort During Medial Branch Block
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