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

NCT ID: NCT00901082

Last Updated: 2015-10-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-04-30

Study Completion Date

2012-02-29

Brief Summary

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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.

Detailed Description

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Conditions

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Chronic Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Caregivers

Study Groups

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information and relaxation

will receive the intervention that consist of information and relaxation

Group Type ACTIVE_COMPARATOR

Relaxation and information session

Intervention Type BEHAVIORAL

Relaxation and information session before the medial branch block

No intervention

No specific intervention before the medial branch block.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Relaxation and information session

Relaxation and information session before the medial branch block

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Louise Lamb

OTHER

Sponsor Role lead

Responsible Party

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Louise Lamb

Nurse

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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MUHC, Montreal General Hospital

Montreal, Quebec, Canada

Site Status

Countries

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Canada

Other Identifiers

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GEN08-051

Identifier Type: -

Identifier Source: org_study_id

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