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Completed

NCT Number: NCT00901082

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

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.

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Key information

Conditions

Chronic Pain Anxiety Disorders Mental Disorders Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

MUHC, Montreal General Hospital

Montreal, Quebec, H3G 1A4, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Relaxation and information session

Behavioral

Relaxation and information session before the medial branch block

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Louise Lamb

Other

Registry information

Official study title

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

Acronym: TIRAP

Important dates

Study start
2009
Primary completion
2011
Study completion
2012
First posted
May 13, 2009
Registry last updated
Oct 6, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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