NCT04975659 - 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)

Dutt-Gupta J, Bown T, Cyna AM
Effect of communication on pain during intravenous cannulation: a randomized controlled trial. Br J Anaesth. 2007 Dec;99(6):871-5. doi: 10.1093/bja/aem308. Epub 2007 Oct 30.
Moerman N, van Dam FS, Muller MJ, Oosting H
The Amsterdam Preoperative Anxiety and Information Scale (APAIS). Anesth Analg. 1996 Mar;82(3):445-51. doi: 10.1097/00000539-199603000-00002.
Mohd Fahmi Z, Lai LL, Loh PS
Validation of the Malay version of the Amsterdam Preoperative Anxiety and Information Scale (APAIS). Med J Malaysia. 2015 Aug;70(4):243-8.
Varelmann D, Pancaro C, Cappiello EC, Camann WR
Nocebo-induced hyperalgesia during local anesthetic injection. Anesth Analg. 2010 Mar 1;110(3):868-70. doi: 10.1213/ANE.0b013e3181cc5727. Epub 2009 Dec 30.

Placebo Versus Nocebo: Effects on Pain and Anxiety During Local Anaesthetic Infiltration in Parturient Undergoing Elective Caesarean Delivery

Clinical trial NCT04975659 - References