Chronic PainTIRAPNCT00901082
The Effectiveness of Information and Relaxation on Pre-procedural Block Anxiety and Procedural Discomfort During Medial Branch Block
A study testing Relaxation and information session in people with Chronic Pain, run by Louise Lamb at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Chronic Pain
- What is being tested?
- Relaxation and information session
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2009to Feb 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patient scheduled to have a medial branch block
- over 18 years of age
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effectiveness of Information and Relaxation on Pre-procedural Block Anxiety and Procedural Discomfort During Medial Branch Block: a Randomized Controlled Trial
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.
- Conditions
- Chronic Pain
- Being tested
- Relaxation and information session
- Keywords
- chronic pain, anxiety, intervention, information, relaxation
- Medical subject headings
- Chronic Pain, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Relaxation and information sessionBehavioural
Relaxation and information session before the medial branch block
| Study group | Role | What they receive |
|---|---|---|
| information and relaxation | Active comparator | will receive the intervention that consist of information and relaxation Receives: Behavioral: Relaxation and information session |
| No intervention | No intervention | No specific intervention before the medial branch block. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the anxiety level prior to the nerve block as per the state trait anxiety questionnaire
Measured: 5-7 days (Second visit and Day of block)
Secondary outcomes (4)
Perceived pain as measured by NRS (numerical rating scale)
Measured: Throughout the study (Baseline, day of block and 1 month after)
Unchanged catastrophization level
Measured: Baseline and day of block
Satisfaction level of the overall experience
Measured: Day after the block
Ease of performing the nerve block
Measured: Day of block
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2009 (estimated)
- Study startApr 2009
- Primary completionApr 2011
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Louise Lamb
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Louise Lamb, McGill University Health Centre/Research Institute of the McGill University Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00901082
- Sponsor's protocol ID
- GEN08-051
- Acronym
- TIRAP
- Status last verified
- Oct 2015
- First submitted
- 11 May 2009
- Last updated
- 6 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Information and Relaxation on Pre-procedural Block Anxiety and Procedural Discomfort During Medial Branch Block: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT00901082
- Acronym / sponsor ID
- TIRAP / GEN08-051
- Conditions
- Chronic Pain
- Keywords
- chronic pain, anxiety, intervention, information, relaxation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Louise LambUniversity, hospital or other
- Study start
- Apr 2009
- Primary completion
- Apr 2011 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 13 May 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| information and relaxation | Active comparator | Behavioral: Relaxation and information sessionwill receive the intervention that consist of information and relaxation |
| No intervention | No intervention | –No specific intervention before the medial branch block. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patient scheduled to have a medial branch block
- over 18 years of age
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Relaxation and information sessionRelaxation and information session before the medial branch block | Behavioural | information and relaxation |
Primary outcome
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)
4 secondary outcomes
Perceived pain as measured by NRS (numerical rating scale)
Time frame: Throughout the study (Baseline, day of block and 1 month after)
Unchanged catastrophization level
Time frame: Baseline and day of block
Satisfaction level of the overall experience
Time frame: Day after the block
Ease of performing the nerve block
Time frame: Day of block
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Relaxation and information session in people with Chronic Pain, run by Louise Lamb at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2015.