NCT02119936 - 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)

Beckham AJ, Greene TB, Meltzer-Brody S
A pilot study of heart rate variability biofeedback therapy in the treatment of perinatal depression on a specialized perinatal psychiatry inpatient unit. Arch Womens Ment Health. 2013 Feb;16(1):59-65. doi: 10.1007/
Brandon AR, Trivedi MH, Hynan LS, Miltenberger PD, Labat DB, Rifkin JB, Stringer CA
Prenatal depression in women hospitalized for obstetric risk. J Clin Psychiatry. 2008 Apr;69(4):635-43.
MacMullen N, Dulski LA, Pappalardo B
Antepartum vulnerability: stress, coping, and a patient support group. J Perinat Neonatal Nurs. 1992 Dec;6(3):15-25.
Poehlmann J, Fiese BH
The interaction of maternal and infant vulnerabilities on developing attachment relationships. Dev Psychopathol. 2001 Winter;13(1):1-11.

Feasibility of Heart Rate Variability Biofeedback as a Stress Reduction Tool for Hospitalized Pregnant Women at the University of North Carolina at Chapel Hill (UNC-CH)

Details for clinical trial NCT02119936

Clinical trial NCT02119936 - References