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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Louise Lamb, McGill University Health Center
ClinicalTrials.gov Identifier:
NCT00901082
First received: May 11, 2009
Last updated: October 2, 2015
Last verified: October 2015
  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:


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 (numerical rating scale) [ 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 ]

Enrollment: 60
Study Start Date: April 2009
Study Completion Date: February 2012
Primary Completion Date: April 2011 (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   (Adult, Senior)
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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00901082

Locations
Canada, Quebec
MUHC, Montreal General Hospital
Montreal, Quebec, Canada, H3G 1A4
Sponsors and Collaborators
Louise Lamb
  More Information

Responsible Party: Louise Lamb, Nurse, McGill University Health Center
ClinicalTrials.gov Identifier: NCT00901082     History of Changes
Other Study ID Numbers: GEN08-051 
Study First Received: May 11, 2009
Last Updated: October 2, 2015
Health Authority: Canada: Ethics Review Committee

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

Additional relevant MeSH terms:
Chronic Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on July 25, 2016