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STOP-4P for Reducing Anxiety Before Amniocentesis
Sponsor: Hung Vuong Hospital
Summary
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.
Official title: Effectiveness of STOP-4P in Reducing Anxiety Among Pregnant Women Undergoing Amniocentesis: A Randomized Controlled Trial at Hung Vuong Hospital
Key Details
Gender
FEMALE
Age Range
Any - Any
Study Type
INTERVENTIONAL
Enrollment
240
Start Date
2026-09-01
Completion Date
2026-12-31
Last Updated
2026-09-23
Healthy Volunteers
Yes
Conditions
Interventions
STOP4P
STOP-4P is a brief, web-based psychological intervention delivered in an interactive, game-like format and completed in about 10 minutes. It includes eight steps: (1) rating the current emotional state on a 1-10 scale; (2) tapping a virtual bell as a cue to stop and pause briefly; (3) practicing slow breathing with a longer exhalation; (4) noticing areas of discomfort or tension in the body, then relaxing the whole body from head to toe; (5) identifying the current emotion by selecting the closest match from six basic emotions; (6) noticing a worrying thought and imagining letting it go; (7) reconnecting with the baby and writing a short loving message to the baby; and (8) rating the emotional state again on the same 1-10 scale. Participants complete STOP-4P while waiting for amniocentesis.
Informational Video and Supportive Activities
Participants watch a short informational video explaining the amniocentesis procedure. They then write a wish for their baby to place on the "Wish Tree" and create a card for themselves or their baby. These brief activities are intended to provide information and supportive emotional expression before amniocentesis.
Locations (1)
Hung Vuong Hospital
Ho Chi Minh City, Ho Chi Minh, Vietnam