Needle PhobiaPhase 4NCT01623583
Effect of Including Synera® in Discussions on Dialysis Access Conversion in Patients With Needle Phobias
A Phase 4 study testing Enhanced Needle Phobia Intervention and Standard Needle Phobia Intervention in people with Needle Phobia and Phobic Disorders, run by Davita Clinical Research at 3 sites in United States.
Trial summary
An arteriovenous fistula or graft access (AVF/AVG) for dialysis is often considered a superior option for delivery of dialysis, but requires needles to be inserted. Patients on dialysis who indicate fear of needles as the reason for not switching from a long-term central venous catheter (CVC) access to a fistula or… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Needle Phobia, Phobic Disorders
- What is being tested?
- Enhanced Needle Phobia Intervention and Standard Needle Phobia Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 3 sitesUnited States
- Study dates
- Apr 2014to Mar 2015
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient receiving hemodialysis at a DaVita clinic/dialysis center
- Receiving in-center hemodialysis thrice weekly
- Central venous catheter (CVC) use for > 180 days
- Patients report a fear of needles as a top-3-reason for failure to get an arteriovenous fistula/graft
Who cannot join
- Patients have a known intolerance or hypersensitivity to Synera
- Patient with a history of or past diagnosis of severe hepatic disease
- Patient is currently receiving any class 1 antiarrhythmic drugs (i.e., tocainide, mexiletine, etc)
- Patient has a clinically significant illness within 14 days of Screening/Day 1 that, in the opinion of the investigator, would preclude the subject from participating in the study
- Patient has an AVF or AVG in place or is scheduled for placement
- Women and men whose partners are of childbearing potential (defined as premenopausal and not surgically sterilized [ie, bilateral tubal ligation, bilateral oophorectomy, or hysterectomy] or postmenopausal for < 2 years) agree to practice 1 of the following medically acceptable methods of birth control and agree to continue with the regimen throughout the duration of the study: Oral, implantable, or injectable contraceptives for 3 consecutive months before the Screening Visit; Intrauterine device (IUD); and double barrier method (ie, condom, sponge, diaphragm, or vaginal ring with spermicidal jellies or cream)
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- Patient has significant disease or condition that, in the PI's opinion, may interfere with protocol adherence or subjects' ability to provide informed consent
- Patient is unable to read or comprehend English at a 6th grade level
- Patient has a visual impairment and is unable to read the survey instruments
- Patient has a suspected or known access-related infection at the time of enrollment
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Asheville Kidney Center
Asheville, North Carolina, 28805
Sunset Dialysis Center
Rancho Cordova, California, 95670
Natomas Dialysis
Sacramento, California, 95834
About this study
Official title: A Randomized Controlled Study of the Effect of a Needle Phobia or Apprehension Intervention With or Without Synera® on Conversion From Central Venous Catheters to Arteriovenous Fistula or Graft
An arteriovenous fistula or graft access (AVF/AVG) for dialysis is often considered a superior option for delivery of dialysis, but requires needles to be inserted. Patients on dialysis who indicate fear of needles as the reason for not switching from a long-term central venous catheter (CVC) access to a fistula or graft access and who otherwise meet the eligibility criterial will be asked to participate. Patients will receive either a standard or an enhanced intervention to address their fear of needles. The enhanced intervention includes the standard intervention plus video training about Synera and trying out an actual patch. Over the 4 months following the intervention, how many patients sign up to switch access will be tracked.
Read the detailed description
Patients with long-term CVCs (> 180 days) will be recruited for study participation by being asked "Why haven't you gotten a graft or fistula?" Those who indicate fear or discomfort with needles in the top 3 reasons will be consented into the study and administered the AVF/AVG Stages of Change Questionnaire.
The Stages of Change questionnaire has been used extensively in research and has been shown to be highly predictive of people engaging in the behavior of interest. The five stages of change include: 1) Precontemplation: Patient doesn't know about, or knows about but doesn't want to think about, a behavior change; 2) Contemplation: Patients knows about and is beginning to consider behavior change; 3) Planning: Patient is actively investigating and making plans for behavior change; 4) Action: Patient is committed to make the change and/or has taken concrete steps to change behavior; and 5) Maintenance: Patient has made the behavior change and is trying maintain that change.
Patients will be cluster-randomized to receive a standard needle phobia intervention (n = 32), or an enhanced intervention consisting of a standard intervention plus a demonstration of the Synera patch (n = 32) within 15 days of baseline. The intervention will be administered by a study team member. In clinics where there is more than 1 patient randomized to a group, the intervention can be administered to multiple patients simultaneously. The standard intervention will last approximately 20 to 30 minutes. During this time, patients will receive information about the advantages of arteriovenous fistula or graft over central-venous catheter, be taught basic relaxation breathing, see a brief video of a patient overcoming needle fear, and have the opportunity to safely interact with a cannulation needle. In the enhanced intervention, the patient will receive the standard intervention with 2 enhancements: (1) the video will include a segment in which a patient experiences the analgesic effects of the a Synera patch and (2) a Synera patch will be applied at the beginning of the intervention, and 30 minutes later the patient will be given the chance to explore the analgesic effects of Synera.
Patients will complete a Stages of Change questionnaire 1 week after the intervention. Patients will then be followed for 4 months to determine whether or not they have scheduled a vein mapping appointment or have had a fistula or graft access placed.
- Conditions
- Needle Phobia, Phobic Disorders
- Being tested
- Enhanced Needle Phobia Intervention, Standard Needle Phobia Intervention
- Keywords
- lidocaine, tetracaine, Renal dialysis
- Medical subject headings
- Phobic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced Needle Phobia InterventionOther
The enhanced intervention will include the standard intervention, with two enhancements:
- The video will include a segment with a patient using and discussing the analgesic effects of the Synera patch
- Before the intervention, a nurse will explain how Synera works and demonstrate its efficacy by having the patient apply it to the non-dominant forearm and leave it in place for 30 minutes, during the intervention. The patient will then be given the opportunity to gently poke 3 times an area of the forearm at least 3 inches from where the patch was applied, and then poke 3 times the center of the area where the patch was applied. The patient may repeat this process up to 3 times. The patient will be asked if he or she can feel the difference in sensitivity.
Standard Needle Phobia InterventionOther
The standard intervention will include the following components:
- Educational material and discussion with the social worker about the benefits of AVF/AVG over catheter.
- Basic training on relaxation breathing
- Brief video of a patient overcoming needle phobia
- Exposure to a cannulation needle while practicing relaxation breathing, ending in the patients physically holding the needle
| Study group | Role | What they receive |
|---|---|---|
| Enhanced Needle Phobia Intervention | Experimental | Patients will receive enhanced needle phobia intervention comprising the standard intervention plus demonstration of Synera Receives: Other: Enhanced Needle Phobia Intervention |
| Standard Needle Phobia Intervention | Active comparator | Patients will receive the standard intervention for needle phobia Receives: Other: Standard Needle Phobia Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients achieving a score of 3 or 4 on the stages of change questionnaire
The primary outcome measure is how many patients progress from a score of 1 or 2 on the questionnaire (precontemplation or contemplation) as measured before the intervention to a score of 3 or 4 (planning or action) after the intervention, and it is measured one week after the intervention.
Measured: One week after intervention meeting
Secondary outcomes (1)
Proportion of patients for whom the intervention was successful
The secondary outcome measure will be assessed as a two-stage dichotomous indicator of intervention success. Stage 1 will assess if a patient has had dialysis treatment with a fistula or graft as primary access. If yes, the intervention will be considered a success; if no, stage 2 will ask if the patient has had a vein mapping procedure, which would be considered a success.
Measured: Four months after intervention meeting
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2012 (estimated)
- Study startApr 2014
- Primary completionMar 2015
- Study completionMar 2015
Why it stopped: limited qualifying patient population
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Needle PhobiaStudies 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 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Davita Clinical Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Nuvo Research Inc.
- Responsible party
- Sponsor
- Investigators
- Mahesh Krishnan, MD, MPH, MBA, Principal investigator, Davita Clinical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01623583
- Sponsor's protocol ID
- 2012-02-02-NVO-MI
- Status last verified
- Apr 2015
- First submitted
- 31 May 2012
- Last updated
- 16 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Study of the Effect of a Needle Phobia or Apprehension Intervention With or Without Synera® on Conversion From Central Venous Catheters to Arteriovenous Fistula or Graft
- ClinicalTrials.gov ID
- NCT01623583
- Acronym / sponsor ID
- 2012-02-02-NVO-MI
- Conditions
- Needle Phobia, Phobic Disorders
- Keywords
- lidocaine, tetracaine, Renal dialysis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: limited qualifying patient population
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Davita Clinical ResearchIndustry (pharma, biotech, devices)
- Collaborators
- Nuvo Research Inc.
- Study start
- Apr 2014
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 20 Jun 2012 (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.
An arteriovenous fistula or graft access (AVF/AVG) for dialysis is often considered a superior option for delivery of dialysis, but requires needles to be inserted. Patients on dialysis who indicate fear of needles as the reason for not switching from a long-term central venous catheter (CVC) access to a fistula or graft access and who otherwise meet the eligibility criterial will be asked to participate. Patients will receive either a standard or an enhanced intervention to address their fear of needles. The enhanced intervention includes the standard intervention plus video training about Synera and trying out an actual patch. Over the 4 months following the intervention, how many patients sign up to switch access will be tracked.
Detailed description
Patients with long-term CVCs (> 180 days) will be recruited for study participation by being asked "Why haven't you gotten a graft or fistula?" Those who indicate fear or discomfort with needles in the top 3 reasons will be consented into the study and administered the AVF/AVG Stages of Change Questionnaire.
The Stages of Change questionnaire has been used extensively in research and has been shown to be highly predictive of people engaging in the behavior of interest. The five stages of change include: 1) Precontemplation: Patient doesn't know about, or knows about but doesn't want to think about, a behavior change; 2) Contemplation: Patients knows about and is beginning to consider behavior change; 3) Planning: Patient is actively investigating and making plans for behavior change; 4) Action: Patient is committed to make the change and/or has taken concrete steps to change behavior; and 5) Maintenance: Patient has made the behavior change and is trying maintain that change.
Patients will be cluster-randomized to receive a standard needle phobia intervention (n = 32), or an enhanced intervention consisting of a standard intervention plus a demonstration of the Synera patch (n = 32) within 15 days of baseline. The intervention will be administered by a study team member. In clinics where there is more than 1 patient randomized to a group, the intervention can be administered to multiple patients simultaneously. The standard intervention will last approximately 20 to 30 minutes. During this time, patients will receive information about the advantages of arteriovenous fistula or graft over central-venous catheter, be taught basic relaxation breathing, see a brief video of a patient overcoming needle fear, and have the opportunity to safely interact with a cannulation needle. In the enhanced intervention, the patient will receive the standard intervention with 2 enhancements: (1) the video will include a segment in which a patient experiences the analgesic effects of the a Synera patch and (2) a Synera patch will be applied at the beginning of the intervention, and 30 minutes later the patient will be given the chance to explore the analgesic effects of Synera.
Patients will complete a Stages of Change questionnaire 1 week after the intervention. Patients will then be followed for 4 months to determine whether or not they have scheduled a vein mapping appointment or have had a fistula or graft access placed.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Enhanced Needle Phobia Intervention | Experimental | Other: Enhanced Needle Phobia InterventionPatients will receive enhanced needle phobia intervention comprising the standard intervention plus demonstration of Synera |
| Standard Needle Phobia Intervention | Active comparator | Other: Standard Needle Phobia InterventionPatients will receive the standard intervention for needle phobia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient receiving hemodialysis at a DaVita clinic/dialysis center
- Receiving in-center hemodialysis thrice weekly
- Central venous catheter (CVC) use for > 180 days
- Patients report a fear of needles as a top-3-reason for failure to get an arteriovenous fistula/graft
Key exclusion criteria (10 listed)
- Patients have a known intolerance or hypersensitivity to Synera
- Patient with a history of or past diagnosis of severe hepatic disease
- Patient is currently receiving any class 1 antiarrhythmic drugs (i.e., tocainide, mexiletine, etc)
- Patient has a clinically significant illness within 14 days of Screening/Day 1 that, in the opinion of the investigator, would preclude the subject from participating in the study
- Patient has an AVF or AVG in place or is scheduled for placement
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 |
|---|---|---|
| Enhanced Needle Phobia InterventionThe enhanced intervention will include the standard intervention, with two enhancements: * The video will include a segment with a patient using and discussing the analgesic effects of the Synera patch * Before the intervention, a nurse will explain how Synera works and demonstrate its efficacy by having the patient apply it to the non-dominant forearm and leave it in place for 30 minutes, during the intervention. The patient will then be given the opportunity to gently poke 3 times an area of the forearm at least 3 inches from where the patch was applied, and then poke 3 times the center of the area where the patch was applied. The patient may repeat this process up to 3 times. The patient will be asked if he or she can feel the difference in sensitivity. | Other | Enhanced Needle Phobia Intervention |
| Standard Needle Phobia InterventionThe standard intervention will include the following components: 1. Educational material and discussion with the social worker about the benefits of AVF/AVG over catheter. 2. Basic training on relaxation breathing 3. Brief video of a patient overcoming needle phobia 4. Exposure to a cannulation needle while practicing relaxation breathing, ending in the patients physically holding the needle | Other | Standard Needle Phobia Intervention |
Primary outcome
Proportion of patients achieving a score of 3 or 4 on the stages of change questionnaire
Time frame: One week after intervention meeting
The primary outcome measure is how many patients progress from a score of 1 or 2 on the questionnaire (precontemplation or contemplation) as measured before the intervention to a score of 3 or 4 (planning or action) after the intervention, and it is measured one week after the intervention.
1 secondary outcome
Proportion of patients for whom the intervention was successful
Time frame: Four months after intervention meeting
Results and safety
The study was stopped early (reason given: limited qualifying patient population). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2016.
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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.
Mahesh Krishnan, MD, MPH, MBA principal investigator
Davita Clinical Research
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Enhanced Needle Phobia Intervention and Standard Needle Phobia Intervention in people with Needle Phobia and Phobic Disorders, run by Davita Clinical Research at 3 sites in United States.
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 4 inclusion and 10 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: stopped early, as of the sponsor's last update on 16 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: limited qualifying patient population). Results are not available in the source record.
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?
Proportion of patients achieving a score of 3 or 4 on the stages of change questionnaire (time frame: One week after intervention meeting). 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 16 Aug 2016.