We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00901082
Recruitment Status : Completed
First Posted : May 13, 2009
Last Update Posted : October 6, 2015
Sponsor:
Information provided by (Responsible Party):

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
Chronic Pain Behavioral: Relaxation and information session

Study Design

Study Type : Interventional  (Clinical Trial)
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 : April 2009
Primary Completion Date : April 2011
Study Completion Date : February 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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 [ Time Frame: 5-7 days (Second visit and Day of block) ]

Secondary Outcome Measures :
  1. Perceived pain as measured by NRS (numerical rating scale) [ Time Frame: Throughout the study (Baseline, day of block and 1 month after) ]
  2. Unchanged catastrophization level [ Time Frame: Baseline and day of block ]
  3. Satisfaction level of the overall experience [ Time Frame: Day after the block ]
  4. Ease of performing the nerve block [ Time Frame: Day of block ]

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Posted: May 13, 2009    Key Record Dates
Last Update Posted: October 6, 2015
Last Verified: October 2015

Keywords provided by Louise Lamb, 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