The Effectiveness of Information and Relaxation on Pre-procedural Block Anxiety and Procedural Discomfort During Medial Branch Block
TIRAP
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable chronic-pain
Started Apr 2009
Typical duration for not_applicable chronic-pain
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2009
CompletedFirst Submitted
Initial submission to the registry
May 11, 2009
CompletedFirst Posted
Study publicly available on registry
May 13, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2012
CompletedOctober 6, 2015
October 1, 2015
2 years
May 11, 2009
October 2, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in the anxiety level prior to the nerve block as per the state trait anxiety questionnaire
5-7 days (Second visit and Day of block)
Secondary Outcomes (4)
Perceived pain as measured by NRS (numerical rating scale)
Throughout the study (Baseline, day of block and 1 month after)
Unchanged catastrophization level
Baseline and day of block
Satisfaction level of the overall experience
Day after the block
Ease of performing the nerve block
Day of block
Study Arms (2)
information and relaxation
ACTIVE COMPARATORwill receive the intervention that consist of information and relaxation
No intervention
NO INTERVENTIONNo specific intervention before the medial branch block.
Interventions
Relaxation and information session before the medial branch block
Eligibility Criteria
You may qualify if:
- patient scheduled to have a medial branch block
- over 18 years of age
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Louise Lamblead
Study Sites (1)
MUHC, Montreal General Hospital
Montreal, Quebec, H3G 1A4, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- CARE PROVIDER
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Nurse
Study Record Dates
First Submitted
May 11, 2009
First Posted
May 13, 2009
Study Start
April 1, 2009
Primary Completion
April 1, 2011
Study Completion
February 1, 2012
Last Updated
October 6, 2015
Record last verified: 2015-10