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

• Sponsor: Louise Lamb (Other)
• Overall Status: Completed
• CT.gov ID: NCT00901082
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arms: 2
• Duration (Months): 34
• Patients Per Site Per Month: 1.8

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Pain	Behavioral: Relaxation and information session	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Care Provider)
• 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
• Study Start Date: Apr 1, 2009
• Actual Primary Completion Date: Apr 1, 2011
• Actual Study Completion Date: Feb 1, 2012

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. 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

1. Perceived pain as measured by NRS (numerical rating scale) [Throughout the study (Baseline, day of block and 1 month after)]

2. Unchanged catastrophization level [Baseline and day of block]

3. Satisfaction level of the overall experience [Day after the block]

4. Ease of performing the nerve block [Day of block]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	MUHC, Montreal General Hospital	Montreal	Quebec	Canada	H3G 1A4

Sponsors and Collaborators

• Louise Lamb

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Louise Lamb, Nurse, McGill University Health Centre/Research Institute of the McGill University Health Centre
• ClinicalTrials.gov Identifier: NCT00901082
• Other Study ID Numbers: GEN08-051
• First Posted: May 13, 2009
• Last Update Posted: Oct 6, 2015
• Last Verified: Oct 1, 2015

• Keywords provided by Louise Lamb, Nurse, McGill University Health Centre/Research Institute of the McGill University Health Centre: chronic pain; anxiety; intervention; information; relaxation
• Additional relevant MeSH terms: Chronic Pain

Study Results

No Results Posted as of Oct 6, 2015