Auriculotherapy in labor pain: randomized clinical trial

Authors
Category Primary study
Registry of TrialsBrazilian Registry of Clinical Trials
Year 2023
INTERVENTION: This was a randomized, randomized, controlled clinical trial with quantitative analysis, in accordance with the Consolidated Standards of Reporting Trials (CONSORT) guidelines. The concept is that the calculation of the research sample size contemplates the idea that 2 study groups were considered: Group A (patients who received a 30‐minute intervention) and a group B (patients who received a 60‐minute intervention) . The sample size calculation will consider a 95% confidence level, 90% statistical power, and an allocation ratio. After calculating each arm, the sample size for this research was arranged n= 80 for the intervention group and n= 80 for the control group, totaling 160 participants, however with a loss of 20%, leaving the final sample to be collected from 192 pregnant women. The recruited patients will be hospitalized at the Hospital Instituto Cândida Vargas – ICV, at the Obstetric Center, in active labor. The study will take place on the premises of the institute. The research is linked to the Research Group on Integrative and Complementary Health Practices (GPICs) in the line of research on Application of Pics in clinical research. Women aged over 18 years will be included, in active labor with spontaneous dilation >4cm, of any parity, with two or more contractions in 10 min, with the presence of pain, regardless of the mode of delivery, with intact skin in the auricular pavilion and whose fetus was alive, in cephalic verte Xpresentation and with good conditions of vitality, who agreed to participate in the research, with subsequent signing of the Informed Consent Term (TCLE) and without serious illnesses and/or complications that he considers his high‐risk delivery and excluded those who had a history of excessive psychiatric or neurological disorders CONDITION: G08.686.784.769.326 Labor Pain PRIMARY OUTCOME: It is expected to find a decrease in the level of pain in parturients submitted to auriculotherapy compared to the control group from the verification of a variation of at least 5% in the pre‐ and post‐intervention measurements. SECONDARY OUTCOME: It is expected to observe a minimization of discomfort and evolution to surgical delivery between the intervention and control groups. INCLUSION CRITERIA: Women aged over 18 years; in active labor with spontaneous dilation >4cm, of any parity, with two or more contractions in 10 min; with intact skin in the auricle; whose fetus is alive, in verte Xcephalic presentation and with good conditions of vitality; who agree to participate in the research, with subsequent signing of the Informed Consent Form (TCLE); without serious illnesses and/or complications that consider their delivery to be high risk
Epistemonikos ID: 78c8d148c4d24cdcb3e74dac025aed5b75b35560
First added on: Aug 26, 2024