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

Chronic Pain Clinical Trial

— TIRAP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00901082
• Other study ID #: GEN08-051
• Status: Completed
• Phase: N/A
• First received: May 11, 2009
• Last updated: October 2, 2015
• Start date: April 2009
• Est. completion date: February 2012

Study information

• Verified date: October 2015
• Source: McGill University Health Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: February 2012
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Caregiver), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Chronic Pain

Intervention

Behavioral:
• Relaxation and information session
Relaxation and information session before the medial branch block

Locations

Country	Name	City	State
Canada	MUHC, Montreal General Hospital	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Louise Lamb

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	Perceived pain as measured by NRS (numerical rating scale)		Throughout the study (Baseline, day of block and 1 month after)	No
Secondary	Unchanged catastrophization level		Baseline and day of block	No
Secondary	Satisfaction level of the overall experience		Day after the block	No
Secondary	Ease of performing the nerve block		Day of block	No