STOP-4P for Reducing Anxiety Before Amniocentesis
The goal of this clinical trial is to learn if STOP-4P can lower anxiety in pregnant women having amniocentesis. Amniocentesis is a prenatal test. A doctor uses a needle to collect a small amount of fluid around the baby. The main question this trial aims to answer is: Does STOP-4P lower anxiety compared with other forms of support and routine care? Researchers will compare three groups: (1) The STOP-4P group will receive routine care, watch a short video about amniocentesis, take part in simple support activities, and practice STOP-4P before the procedure, (2) The control group will receive the same care, video, and support activities but will not practice STOP-4P and (3) The observational group will receive routine care only. Participants in the STOP-4P and control groups will be assigned at random. Those in the observational group will be enrolled separately without random assignment. Researchers will also look at well-being, pain, heart rate, and blood pressure. Participants will: (1) Answer short questions about anxiety and well-being before amniocentesis and 30 minutes after the procedure, (2) Have their heart rate and blood pressure measured before amniocentesis, at the start of the procedure, and 30 minutes afterward, (3) Complete the activities assigned to their study group and (4) Rate the pain they felt during amniocentesis. After the main study assessments are completed, all participants will be offered access to STOP-4P and may practice it at home if they choose. About 2 weeks after amniocentesis, the study team will record the test result, any complications, and how often participants practiced STOP-4P at home. Participants can also talk with the study team about psychological or medical concerns if needed.
Pregnant women in the second trimester who are scheduled to undergo diagnostic a... [+2]
Previous diagnosis of a psychiatric disorder, such as generalized anxiety disord... [+3]