The Effectiveness of Information and Relaxation on Pre-pr... | NCT00901082

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

NCT00901082

Sponsor

Louise Lamb

Status

Completed

Last Update Posted

Oct 6, 2015Estimated

Enrollment

60Actual

Phase

Not Applicable

Conditions

Chronic Pain

Interventions

Relaxation and information session

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2009

Primary Completion Date

Apr 2011Actual

Completion Date

Feb 2012Actual

First Submitted Date

May 11, 2009

First Submission Date that Met QC Criteria

May 12, 2009

First Posted Date

May 13, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 2, 2015

Last Update Posted Date

Oct 6, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Louise Lamb, Nurse, McGill University Health Centre/Research Institute of the McGill University Health CentreSponsor-Investigator

Lead Sponsor

Louise LambOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
information and relaxation	Active Comparator	will receive the intervention that consist of information and relaxation	Behavioral: Relaxation and information session
No intervention	No Intervention	No specific intervention before the medial branch block.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Relaxation and information session	Behavioral	Relaxation and information session before the medial branch block	information and relaxation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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 Outcomes

Measure	Description	Time Frame
Perceived pain as measured by NRS (numerical rating scale)		Throughout the study (Baseline, day of block and 1 month after)
Unchanged catastrophization level		Baseline and day of block

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
MUHC, Montreal General Hospital		Montreal	Quebec	H3G 1A4	Canada

Condition Browse Module

MeSH Terms

ID	Term
D059350	Chronic Pain
D001008	Anxiety Disorders

Ancestor Terms

ID	Term
D010146	Pain
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided