anxiety
Conditions
Interventions
This is a randomized controlled trial, with masking of participants, assessors, and analysts, with two arms (experimental and control). A total of 150 postpartum women will be enrolled, stratified by
Sponsors
Universidade Federal de Santa Catarina
Universidade Federal de Santa Catarina
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Postpartum women with vaginal delivery or cesarean section performed at the University Hospital of the Federal University of Santa Catarina (HU-UFSC) less than 24 hours before enrollment in rooming-in care; singleton term pregnancy; individuals with full civil capacity aged 18 years or older in full exercise of their mental faculties and capable of consenting to participate in the research; presence of a companion or professional able to attend to and/or care for the newborn during the treatment
Exclusion criteria
Exclusion criteria: Maternal clinical or obstetric conditions that prevent self-care such as going to the bathroom bathing and ambulating; neonatal conditions that prevent full-time rooming-in; communication difficulties; maternal hypertension even if controlled with medication; maternal cardiac conditions; asthma or symptomatic and/or medicated obstructive pulmonary disease at the time of the research; surgical reintervention for any reason after vaginal delivery or cesarean section; infection or any condition of the auricular pavilion; use of pacemaker implantable cardioverter-defibrillator or insulin pump; use of beta-blockers; coagulation disorders; expected hospital discharge less than 16 hours after participation in the research
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assess pain intensity in the immediate postpartum period, measured 12 to 18 hours after the second auricular vagal nerve stimulation session (approximately 30 to 52 hours after the first session, depending on the timing of the second session). Verified using the Visual Analog Scale (VAS), validated for use in the postoperative and postpartum period. A 10-cm line will be used, anchored at the extremes by the expressions "no pain" and "worst pain imaginable," with a score ranging from 0 to 100 mm | — |
Secondary
| Measure | Time frame |
|---|---|
| Assess autonomic modulation before, during, and after the second auricular vagal nerve stimulation session. Verified using heart rate variability (HRV), with continuous 20-minute recording during the session, using the Polar H10 heart rate monitor (Polar Electro, Kempele, Finland) and analysis through the Kubios software. Time-domain parameters will be analyzed, including mean heart rate, standard deviation of RR intervals, and root mean square of successive differences between adjacent RR intervals, as well as frequency-domain parameters, including spectral power in the low- and high-frequency bands and their ratio, in addition to Poincaré plot analysis and Mayer wave analysis;Assess the evolution of pain throughout the immediate postpartum period, at five time points: before and after the first auricular vagal nerve stimulation session (T0), before and after the second session (T1), and at the time of the final interviews (T2). Verified using the Visual Analog Scale (VAS), with a score ranging from 0 to 100 mm. The variation in scores across time points will be analyzed, allowing the acute effect of each session to be distinguished from the sustained effect of the intervention;Assess obstetric recovery quality in the immediate postpartum period. Verified using the Obstetric Quality of Recovery-10 instrument (ObsQoR-10©), validated for Brazilian Portuguese, administered at the time of the final interviews (T2). Scores will be analyzed across the dimensions of pain, nausea, malaise, ability to care for the newborn, mobility, communication, emotional well-being, and anxiety, with a total score ranging from 0 to 100;Assess generalized anxiety symptoms in the immediate postpartum period. Verified using the Generalized Anxiety Disorder-7 scale (GAD-7), validated for Brazilian Portuguese, administered at the time of the final interviews (T2). The total score, calculated as the sum of the seven items on a Likert scale from 0 to 3, will be analyzed;Assess state anxiety in | — |
Countries
BR
Contacts
Public ContactRoxana Knobel
Universidade Federal de Santa Catarina
Outcome results
None listed