NCT05560074 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Ballard A, Khadra C, Adler S, Trottier ED, Le May S
Efficacy of the Buzzy Device for Pain Management During Needle-related Procedures: A Systematic Review and Meta-Analysis. Clin J Pain. 2019 Jun;35(6):532-543. doi: 10.1097/AJP.0000000000000690.
Birnie KA, Chambers CT, Fernandez CV, Forgeron PA, Latimer MA, McGrath PJ, Cummings EA, Finley GA
Hospitalized children continue to report undertreated and preventable pain. Pain Res Manag. 2014 Jul-Aug;19(4):198-204. Epub 2014 May 7.
Gerçeker GÖ, Binay S, Bilsin E, Kahraman A, Yilmaz HB
Effects of Virtual Reality and External Cold and Vibration on Pain in 7- to 12-Year-Old Children During Phlebotomy: A Randomized Controlled Trial. J Perianesth Nurs. 2018 Dec;33(6):981-989. doi: 10.10
McMurtry CM, Noel M, Chambers CT, McGrath PJ
Children's fear during procedural pain: preliminary investigation of the Children's Fear Scale. Health Psychol. 2011 Nov;30(6):780-8. doi: 10.1037/a0024817. Epub 2011 Aug 1.
Sivri Bilgen B, Balci S
The Effect on Pain of Buzzy® and ShotBlocker® during the Administration of Intramuscular Injections to Children: A Randomized Controlled Trial. J Korean Acad Nurs. 2019 Aug;49(4):486-494. doi: 10.4040/jkan.2019.49.4.486.
Walco GA
Needle pain in children: contextual factors. Pediatrics. 2008 Nov;122 Suppl 3:S125-9. doi: 10.1542/peds.2008-1055d. Review.

The Effect of Two Different Non-pharmacologic Methods (Buzzy® and DistrACTION® Cards) for Pain and Fear Relief During Blood Specimen Collection in Children: A Randomized Controlled Trial

Details for clinical trial NCT05560074

Clinical trial NCT05560074 - References