NCT04886648 - 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)

Alipour Z, Eskandari N, Ahmari Tehran H, Eshagh Hossaini SK, Sangi S
Effects of music on physiological and behavioral responses of premature infants: a randomized controlled trial. Complement Ther Clin Pract. 2013 Aug;19(3):128-32. doi: 10.1016/j.ctcp.20
Keith DR, Russell K, Weaver BS
The effects of music listening on inconsolable crying in premature infants. J Music Ther. 2009 Fall;46(3):191-203.
Liaw JJ, Yang L, Lee CM, Fan HC, Chang YC, Cheng LP
Effects of combined use of non-nutritive sucking, oral sucrose, and facilitated tucking on infant behavioural states across heel-stick procedures: a prospective, randomised controlled trial. Int J Nurs
Peng NH, Chen LL, Li TC, Smith M, Chang YS, Huang LC
The effect of positioning on preterm infants' sleep-wake states and stress behaviours during exposure to environmental stressors. J Child Health Care. 2014 Dec;18(4):314-25. doi: 10.1177/13674935134966
Robertson AM, Detmer MR
The Effects of Contingent Lullaby Music on Parent-Infant Interaction and Amount of Infant Crying in the First Six Weeks of Life. J Pediatr Nurs. 2019 May - Jun;46:33-38. doi: 10.1016/j.pedn.2019.02.025. Epub 2019 Feb 28.

THE EFFECT OF MOTHER'S VOICE AND LULLABY ON PRETERM INFANTS' PHYSIOLOGICAL PARAMETERS, STRESS AND SLEEPING- WAKING STATE

Clinical trial NCT04886648 - References