NCT02802839 - 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)

Ayers S, Muller I, Mahoney L, Seddon P
Understanding needle-related distress in children with cystic fibrosis. Br J Health Psychol. 2011 May;16(Pt 2):329-43. doi: 10.1348/135910710X506895. Epub 2011 Mar 9.
Bisogni S, Dini C, Olivini N, Ciofi D, Giusti F, Caprilli S, Gonzalez Lopez JR, Festini F
Perception of venipuncture pain in children suffering from chronic diseases. BMC Res Notes. 2014 Oct 18;7:735. doi: 10.1186/1756-0500-7-735.
Duff AJ
Psychological interventions in cystic fibrosis and asthma. Paediatr Respir Rev. 2001 Dec;2(4):350-7. Review.
Gold JI, Kim SH, Kant AJ, Joseph MH, Rizzo AS
Effectiveness of virtual reality for pediatric pain distraction during i.v. placement. Cyberpsychol Behav. 2006 Apr;9(2):207-12.
Sermet-Gaudelus I, De Villartay P, de Dreuzy P, Clairicia M, Vrielynck S, Canoui P, Kirzsenbaum M, Singh-Mali I, Agrario L, Salort M, Charron B, Dusser D, Lenoir G, Hubert D
Pain in children and adults with cystic fibrosis: a comparative study. J Pain Sy

The Use of Virtual Reality in the Reduction of Pain and Anxiety During Venipuncture in Children With Cystic Fibrosis: a Randomized Controlled Trial

Clinical trial NCT02802839 - References