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The Effectiveness of Information and Relaxation on Pre-procedural Block Anxiety and Procedural Discomfort During Medial Branch Block (TIRAP)

This study is currently recruiting participants.
Verified July 2011 by McGill University Health Center
Sponsor:
Information provided by:
McGill University Health Center
ClinicalTrials.gov Identifier:
NCT00901082
First received: May 11, 2009
Last updated: July 19, 2011
Last verified: July 2011
History of Changes

May 11, 2009
July 19, 2011
April 2009
July 2012   (final data collection date for primary outcome measure)
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) ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00901082 on ClinicalTrials.gov Archive Site
  • Perceived pain as measured by NRS [ Time Frame: Throughout the study (Baseline, day of block and 1 month after) ] [ Designated as safety issue: No ]
  • Unchanged catastrophization level [ Time Frame: Baseline and day of block ] [ Designated as safety issue: No ]
  • Satisfaction level of the overall experience [ Time Frame: Day after the block ] [ Designated as safety issue: No ]
  • Ease of performing the nerve block [ Time Frame: Day of block ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
The Effectiveness of Information and Relaxation on Pre-procedural Block Anxiety and Procedural Discomfort During Medial Branch Block
The Effectiveness of Information and Relaxation on Pre-procedural Block Anxiety and Procedural Discomfort During Medial Branch Block: a Randomized Controlled Trial

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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Caregiver)
Primary Purpose: Supportive Care
Chronic Pain
Behavioral: Relaxation and information session
Relaxation and information session before the medial branch block
  • Active Comparator: information and relaxation
    will receive the intervention that consist of information and relaxation
    Intervention: Behavioral: Relaxation and information session
  • No Intervention: No intervention
    No specific intervention before the medial branch block.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
80
July 2012
July 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years
No
Contact: Louise Lamb, R.N. B.Sc.N. 514.934.1934 ext 43597 louise.lamb@muhc.mcgill.ca
Canada
 
NCT00901082
GEN08-051
No
Louise Lamb, MUHC, Montreal General Hospital
McGill University Health Center
Not Provided
Not Provided
McGill University Health Center
July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP