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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Pain
• Intervention / Treatment: Behavioral: Relaxation and information session

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada, H3G 1A4
      • MUHC, Montreal General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Louise Lamb

Study record dates

Study Major Dates

• Study Start: April 1, 2009
• Primary Completion (Actual): April 1, 2011
• Study Completion (Actual): February 1, 2012

Study Registration Dates

• First Submitted: May 11, 2009
• First Submitted That Met QC Criteria: May 12, 2009
• First Posted (Estimate): May 13, 2009

Study Record Updates

• Last Update Posted (Estimate): October 6, 2015
• Last Update Submitted That Met QC Criteria: October 2, 2015
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Keywords: chronic pain; anxiety; intervention; relaxation; information
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain
• Other Study ID Numbers: GEN08-051