None listed
Conditions
Brief summary
NeedleCalm is a single-use disposable medical device to alleviate pain associated with injections and assist with the reduction of fear of injections. The NeedleCalm™ technology uses the gate control theory of pain awareness and transmission.The device will be intended for use for all blood collections, intravenous cannula insertion, IM and SC injections.
Interventions
Study Day 1 – In House
At Approximately 8 am, a study nurse will document participants’ vital signs (blood pressure, heart rate, temperature, respiration rate). Participants will be randomised to the treatment that is first administered. Subsequently, participants will be asked to sit on a chair and extend their dominant arm underneath a barrier which prevents them from watching the procedure. NeedleCalm™ or a placebo will be applied to the area where the venepuncture is to be performed. The nu
Study Day 1 – In House At Approximately 8 am, a study nurse will document participants’ vital signs (blood pressure, heart rate, temperature, respiration rate). Participants will be randomised to the treatment that is first administered. Subsequently, participants will be asked to sit on a chair and extend their dominant arm underneath a barrier which prevents them from watching the procedure. NeedleCalm™ or a placebo will be applied to the area where the venepuncture is to be performed. The nurse will then administer a standard venepuncture procedure on the participant’s cubital fossa and collect 5 ml of blood while another registered nurse is sitting by the participant side to monitor for adverse events. All blood samples collected from participants will be discarded and will not be used for analysis. After the procedure, the needle will be disposed of in a sharps bin and the body of the device is removed and disposed of as medical waste. The adhesive remaining on the skin includes a flap which is folded over and adheres to the injection site, replacing the need for a cotton wool ball and separate band-aid. Immediately after the needle and the device have been removed, participants will be asked to complete the Southampton Needle Sensation Questionnaire to evaluate procedure-related needle sensation and pain. Vital signs will be measured after the completion of the questionnaire. Four hours after the first venepuncture has been performed, the exact same procedure is to be repeated using the remaining Investigational Product. Participants vital signs will be measured before and after. Once more, participants will be asked to complete the Southampton Needle Sensation Questionnaire after the second venepuncture . Participants will be kept under observation for one hour after the second procedure has been performed for the emergence of new symptoms and will subsequently be able to leave the facility provided that there are no health and safety concerns (between approximately 1:30 and 4:30 pm). Study Day 2 – Home Twenty-four hours after the administration of the second intervention, study staff will contact participants via telephone to follow-up on the treatments received and ensure that there are no health and safety concerns. Therefore, participants will be closely monitored for adverse events from the signing of the informed consent until 24 hours after the administration of the second intervention. Placebo is a standard band-aid which consists of a small gauze pad and adhesive bandage. The Needlecalm device is applied to the skin approximately 30 seconds prior to venepuncture. The Needlecalm device comprises of a medical grade nylon material. It is intended for use in venepuncture, Intravenous cannulation, intramuscular and sub cutaneous injections.
Sponsors
Needlecalm Pty Ltd
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject)
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
1) Participants between 18 and 60 years of age at time of entry on study; 2) Cognitive ability to understand informed consent process and to give informed consent to the experimental treatment; 3) Participants agree to undergo a venepuncture procedure once per procedure in the cubital fossa of the dominant arm and have 5 ml of blood collected; (i.e 10ml of blood will be collected). 4) Participants agree to adhere to the study protocol; 5) No history of illicit intravenous drug use; 6) No history of needle-phobia (trypanophobia); 7) No history of any chronic diseases.
Exclusion criteria
1) Any clinically relevant abnormal findings which, in the opinion of the investigators / clinicians, may put the participant at risk of adverse events because of participation in the clinical trial including: physical examination, medical history, clinical chemistry, haematology, urinalysis, vital signs; 2) Current or previous allergies or allergic responses to latex; 3) Current use of any intravenously administered, prescribed or illicit drugs; 4) Any history of moderate to severe needle-phobia (trypanophobia); 5) Pregnant or nursing an infant; 6) Any psychiatric disorders by history or examination that would prevent completion of the venepuncture procedure or result in possible adverse events for the participant; 7) The current use of any prescribed or over the counter analgesia (7 days wash-out period required); 8) Not have received more than two needle procedures in the past 12 months.
Outcome results
None listed