Importance: Attention is being focused on improving mothers' positive experiences of childbirth while reducing the negative ones. Cesarean section is a known factor able to increase maternal anxiety.
Objective: To determine whether a new binaural beat-based technique can reduce the preoperative discomfort of the elective surgical patient.
Methods: Prospective, randomized double-blind controlled study: 60 women scheduled to undergo elective cesarean section. Women with a low risk pregnancy were recruited and enrolled at the time of the "37 weeks" visit. Exclusion criteria were: psychiatric disorders, neurological impairment, epilepsy, deafness, use of drugs/alcohol during pregnancy, insufficient reading level. Participants will be contestually allocated to one of three groups according to a predetermined computer-generated random sequence: (1) "binaural" group, (2) "normal music" group, and (3) "control" group. Participants of groups 1 and 2 will be unaware of the type of audio heard.
Intervention: According to the allocation arm, participants were asked to listen an engineered audio track (binaural beat arm) created with the novel algorithm "Dynamic Spectrum Phase Shift" (DMSPS), or an identical soundtrack without DMSPS in it (music arm), or no specific intervention, representing standard practice. The feeling of anxiety has been measured by the State-Trait Anxiety Inventory (STAI-Y) questionnaire.Conclusions and Relevance: Binaural beat audio created with DMSPS algorithm provides superior changes in reported anxiety in comparison to normal music and above all to standard care.This technique does not need extra staff or extra staying time for the patients, so it could be a cost-effective way to manage preoperative anxiety in women undergoing elective cesarean section, with a potential impact to the mother's positive experiences and care of the newborn. The EudraCT number: 2019-000743-27.
Keywords: Pregnancy; complementary therapies; psychological wellbeing; stress; women.