STOP-4P for Reducing Anxiety Before Amniocentesis

Overview

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.

Amniocentesis may cause short-term anxiety because pregnant women may worry about the procedure, possible pain or complications, fetal safety, and uncertainty about the test result. The waiting period before amniocentesis was chosen as the intervention window because these concerns are already present before the procedure. It also gives participants time to receive a brief psychological intervention with minimal disruption to routine clinical care. At enrollment, participants in all three study groups are stratified according to the clinical indication for amniocentesis. Different diagnoses and indications may be associated with different levels of anxiety before the procedure. Stratification helps control these baseline differences and improves comparability among the groups within each stratum before the next group allocation steps. The protocol also includes a non-randomized observational comparison group receiving routine care alone. This group is enrolled during separate prespecified study sessions. Including this group helps distinguish the added effect of STOP-4P from the effects of other study-related supportive activities and from routine care alone. All participants are offered access to STOP-4P after the main post-procedure assessment has been completed. This delayed access allows participants who did not receive STOP-4P before amniocentesis to use it while waiting for the test result, without affecting the main study comparison. Anxiety and well-being are not reassessed at the two-week follow-up because participants' emotional responses may be strongly influenced by the amniocentesis result, especially if the result is abnormal. The later follow-up therefore focuses on clinical information and the use of STOP-4P rather than on evaluating its main anxiety-reduction effect.