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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
  Purpose

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.


Condition Intervention
Chronic Pain
 Behavioral: Relaxation and information session

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Caregiver)
Primary Purpose: Supportive Care
Official Title: The Effectiveness of Information and Relaxation on Pre-procedural Block Anxiety and Procedural Discomfort During Medial Branch Block: a Randomized Controlled Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by McGill University Health Center:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 80
Study Start Date: April 2009
Estimated Study Completion Date: July 2012
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: information and relaxation
will receive the intervention that consist of information and relaxation
 Behavioral: Relaxation and information session
Relaxation and information session before the medial branch block
No Intervention: No intervention
No specific intervention before the medial branch block.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00901082

Contacts
Contact: Louise Lamb, R.N. B.Sc.N. 514.934.1934 ext 43597 louise.lamb@muhc.mcgill.ca

Locations
Canada, Quebec
MUHC, Montreal General Hospital Recruiting
Montreal, Quebec, Canada, H3G 1A4
Contact: Louise Lamb, R.N. B.Sc.N.         louise.lamb@muhc.mcgill.ca    
Principal Investigator: Louise Lamb, R.N. B.Sc.N.            
Sponsors and Collaborators
McGill University Health Center
  More Information

No publications provided

Responsible Party: Louise Lamb, MUHC, Montreal General Hospital
ClinicalTrials.gov Identifier: NCT00901082     History of Changes
Other Study ID Numbers: GEN08-051
Study First Received: May 11, 2009
Last Updated: July 19, 2011
Health Authority: Canada: Ethics Review Committee

Keywords provided by McGill University Health Center:
chronic pain
anxiety
intervention
information
relaxation

Additional relevant MeSH terms:
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 16, 2013