None listed
Conditions
Brief summary
This study is testing whether a hand-held light device can reduce the pain of needle injections into the skin. Each participant will have the light device placed briefly on one forearm, and a different, inactive-looking light device placed on the other forearm, before receiving a small injection on each arm. We expect that the arm treated with the active device will feel less pain during the needle insertion and injection than the arm treated with the inactive device. Pain will be measured straight after each injection using a simple 0–10 pain rating scale, and participants will also be asked about any side effects up to one week later. We hope this study will show whether this light-based device is a safe and effective way to reduce pain from injections.
Interventions
What is the intervention
A multi-wavelength light-emitting diode (LED) device (700–1100nm, spanning visible and near-infrared light), applied to the skin to induce photobiomodulation-based analgesia prior to intradermal injection.
Who delivers it and their relevant expertise
The device is applied and the procedure conducted by the site investigators (dermatology medical clinicians) at Westmead Hospital Dermatology Outpatient Clinic that have been trained in the use of the device.
How it is del
What is the intervention A multi-wavelength light-emitting diode (LED) device (700–1100nm, spanning visible and near-infrared light), applied to the skin to induce photobiomodulation-based analgesia prior to intradermal injection. Who delivers it and their relevant expertise The device is applied and the procedure conducted by the site investigators (dermatology medical clinicians) at Westmead Hospital Dermatology Outpatient Clinic that have been trained in the use of the device. How it is delivered Face-to-face, individual (one-on-one), in-person clinical procedure. The device is placed directly over a marked 1cm × 1cm site on the volar forearm. The participant will then receive an intradermal injection with a 30gauge needle with 0.1mL of 0.9% normal saline solution. The participant will then have a Telehealth phone call 1 week later to assess for any side effects. How often and for how long A single application per arm: the device is activated and held over the site for 60 seconds immediately before injection. Each participant receives this once on each forearm (one arm gets the intervention, the other the sham/control device) in a single study visit — i.e., 2 applications total (once per arm) within one session, of 60 seconds' duration each. No washout period is required as the previous device and injection will not have an effect on the other arm. The participant will then have a Telehealth phone call 1 week later to assess for any side effects. Where it is delivered Tertiary hospital setting: Dermatology Outpatient Clinic, Westmead Hospital, Sydney, Australia. Adherence As this is a single-session, investigator-administered procedure (not a self-administered or take-home intervention), adherence is ensured by direct investigator delivery and observation rather than participant reminders. Device application is standardised (60 seconds, over a marked and measured skin site) to ensure consistency across participants.
Sponsors
Dentroid
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Aged 18 years or older, able to provide consent Able to use both forearms Normal skin overlying both forearms Able to verbalise and report pain
Exclusion criteria
Known hypersensitivity to 0.9% sodium chloride and/or hypodermic needles Medical conditions that may be exacerbated by visible or near-infrared light devices Medical conditions that may alter ability to detect/report pain and sensation at injection sites Use of topical or systemic analgesia within 24 hours prior to the visit
Outcome results
None listed