None listed
Conditions
Brief summary
In this study, we are trying to find out if a novel, inexpensive, non-invasive medical device might reduce pain associated with blood test. We are aiming to recruit participants who are undergoing regular blood tests in the setting of a fertility clinic. Given this is a pilot trial, we plan to recruit up to 40 participants and randomise them into the medical device group, or the control group. We hypothesise that our non-invasive device will reduce or eliminate pain associated with venepuncture, whilst not compromising the success probability of obtaining adequate blood sample.
Interventions
We are testing the efficacy of a novel, inexpensive, non-invasive device for the purpose of reducing pain associated with venepuncture. The device employs a detachable ‘distractor tip’ proximal to the needle tip of a phlebotomy device, wherein the distractor tip is configured to contact the tissue surface once only, lasting for a few seconds, before and during insertion of the phlebotomy needle; thereby providing a stimulant to the non-nociceptive nerve fibres and, in effect, inhibiting adjacent
We are testing the efficacy of a novel, inexpensive, non-invasive device for the purpose of reducing pain associated with venepuncture. The device employs a detachable ‘distractor tip’ proximal to the needle tip of a phlebotomy device, wherein the distractor tip is configured to contact the tissue surface once only, lasting for a few seconds, before and during insertion of the phlebotomy needle; thereby providing a stimulant to the non-nociceptive nerve fibres and, in effect, inhibiting adjacent pain fibres. Adherence to the intervention will be directly monitored by research staff.
Sponsors
Prudenfort Pty Ltd
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject)
Eligibility
Sex/Gender
All
Age
18 Years to 48 Years
Healthy volunteers
Yes
Inclusion criteria
Patients undergoing routine blood testing for the purpose of cycle tracking, at the time of fertility treatment.
Exclusion criteria
Patients who are attending phlebotomy for non cycle-tracking purposes.
Outcome results
None listed