Auriculotherapy in the treatment of gestational nausea and vomiting: a randomized clinical trial

Category Primary study
Registry of TrialsBrazilian Registry of Clinical Trials
Year 2022
INTERVENTION: D055097 Participants will be allocated into one of four groups: treated (semi‐permanent needle and low‐power laser), placebo (cotton microspheres), and control. There is no identification in DeCS for semi‐permanent needle or cotton microspheres. CONDITION: Study performed with pregnant women who report pregnancy‐related nausea and vomiting in the first trimester of pregnancy. Auriculotherapy and laser puncture will be applied to treat these symptoms. PRIMARY OUTCOME: The primary outcome is the reduction in nausea and vomiting during pregnancy, assessed using the Pregnancy Score Unique Quantification of Emesis (PUQE) instrument, a Likert scale with 5 options, answering 3 basic questions related to gestational nausea and vomiting. It will also be evaluated by reactivity to palpation at the points, classified as Grade I (the participant verbally reports the pain), II (the participant expresses pain through the face), and III (the participant tries to prevent the examination by removing the head or bringing your hand to the examiner's hand).; ; The secondary outcome is the quality of life of pregnant women with gestational nausea and vomiting, verified through the instrument Health‐Related Quality of Life Questionnaire for Nausea and Vomiting of Pregnancy (NVPQOL) – translated and validated version in Portuguese. INCLUSION CRITERIA: Pregnant women referred to the AEHU from prenatal care at usual risk will be included, and pregnant women at usual risk attended at UBS in the city of Londrina‐PR, with a chronological age above 18 years; gestational age between 5 and 16 weeks proven by USG, regardless of parity, who report symptoms of nausea and/or vomiting as mild (PUQUE score <6) or moderate (PUQUE score between 7 and 11).
Epistemonikos ID: baf2e426c449275065c8cda1e689fb5026c28e08
First added on: Aug 25, 2024