The effect of auricular acupuncture on anxiety in pregnant women

Authors
Category Primary study
Registry of TrialsBrazilian Registry of Clinical Trials
Year 2023
INTERVENTION: Pregnant women in the municipality will be screened, and those who meet the inclusion criteria will be invited to participate in the study. After assessments of anxiety, quality of life, fear of covid‐19 and social and obstetric characterization, the envelope containing the randomization will be opened and the pregnant woman will be allocated to one of the groups: auricular acupuncture (50 women) and placebo group (50 women). There will be 4 sessions with auricular acupuncture protocol for anxiety in pregnant women, previously validated by specialists. E02.190.204 CONDITION: Anxiety F01.470.132 PRIMARY OUTCOME: Anxiety reduction, assessed using the State‐Trait Anxiety Inventory (STAI). The same classifies anxiety as mild (20 to 40 points), moderate (40 to 60 points), and high (60 to 80 points). The evaluation will be carried out in the first and fourth session, in addition to the 30‐day follow‐up. The intervention is intended to reduce moderate to high scores. SECONDARY OUTCOME: Secondary outcome 1. Quality of life will be assessed using the World Health Organization Quality of Life‐Bref (WHOQOL‐Bref). The instrument has 26 questions, which assess the individual's physical and mental health through 24 questions that encompass the physical, social, psychological and environmental domains, in addition to 2 questions about the perception of quality of life and satisfaction with health. The intervention is intended to increase the scores obtained in the initial assessment. The questionnaire will be applied in the first and fourth session and in the follow‐up. Secondary outcome 2. Fear of covid‐19 in the perinatal period will be measured by the COVID‐19 Fear Scale in the Perinatal Period (EMC19‐9). It is self‐completed and has nine items with 5‐point Likert scale responses, from “strongly disagree” to “strongly agree”. It is intended that there is a reduction in the total sum after the intervention. The scale will be applied in the first and fourth session and in the follow‐up period. INCLUSION CRITERIA: Pregnant women over 18 years old; up to the gestational age of 37 weeks; availability of time for treatment; and clinically relevant anxiety.
Epistemonikos ID: 45288e7b9c8d6e5a46d57ab5e81cb305fe88c180
First added on: Oct 02, 2023