Skip to main content
Clinical Trials/NCT00901082
NCT00901082
Completed
Not Applicable

The Effectiveness of Information and Relaxation on Pre-procedural Block Anxiety and Procedural Discomfort During Medial Branch Block: a Randomized Controlled Trial

Louise Lamb1 site in 1 country60 target enrollmentStarted: April 2009Last updated:
ConditionsChronic Pain

Overview

Phase
Not Applicable
Status
Completed
Sponsor
Louise Lamb
Enrollment
60
Locations
1
Primary Endpoint
Change in the anxiety level prior to the nerve block as per the state trait anxiety questionnaire

Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
Single (Care Provider)

Eligibility Criteria

Ages
18 Years to 70 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

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 Outcomes

  • Ease of performing the nerve block(Day of block)
  • Perceived pain as measured by NRS (numerical rating scale)(Throughout the study (Baseline, day of block and 1 month after))
  • Satisfaction level of the overall experience(Day after the block)
  • Unchanged catastrophization level(Baseline and day of block)

Investigators

Sponsor
Louise Lamb
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Louise Lamb

Nurse

McGill University Health Centre/Research Institute of the McGill University Health Centre

Study Sites (1)

Loading locations...

Similar Trials