STOP-4P for Reducing Anxiety Before Amniocentesis
ConditionAnxiety
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
AgeNot listed
SponsorHung Vuong Hospital
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Pregnant women in the second trimester who are scheduled to undergo diagnostic amniocentesis at Hung Vuong Hospital.
Able to read and understand Vietnamese, complete the study questionnaires, and follow study instructions.
Willing to participate and provide written informed consent after receiving a full explanation of the study.
Disqualifiers
Previous diagnosis of a psychiatric disorder, such as generalized anxiety disorder, major depression, or schizophrenia.
Current use of psychiatric medication or receipt of psychological intervention during the current pregnancy.
Unable to understand or complete the study questionnaires because of cognitive limitations.
Obstetric emergency at the time of enrollment.
Trial design
Design model
Parallel
Treatments tested in this trial
STOP4P
BehavioralSTOP-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
BehavioralParticipants 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.
Treatment groups
240 Participants
are divided into 3 treatment groupsGroup A: STOP-4P With Video and Supportive ActivitiesExperimental treatment 1 intervention
Group B: Video and Supportive Activities Without STOP-4POther 1 intervention
Group C: Routine Care OnlyNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Changes in State and Trait Anxiety Scores Before and After Amniocentesis
Anxiety is assessed using the 10-item short form of the State-Trait Anxiety Inventory (STAI). It includes two five-item subscales: state anxiety (STAIS-5) and trait anxiety (STAIT-5). Each subscale has a score range of 5 to 20, with higher scores indicating greater anxiety. Both subscales are scored before amniocentesis and 30 minutes after the procedure. For each subscale, the change is calculated as the score after the procedure minus the score before the procedure. A negative change indicates a decrease in anxiety. Changes in state and trait anxiety scores will be compared separately among the STOP-4P, control, and observational groups.
Time frame
From the waiting period before amniocentesis to 30 minutes after amniocentesis.Secondary outcomes
1
Well-being Scores Before and After Amniocentesis
Well-being is assessed using a one-item measure adapted from the Cantril Self-Anchoring Striving Scale. Scores range from 1 to 10, with higher scores indicating greater well-being and a more positive emotional state. Scores are measured before amniocentesis and 30 minutes after the procedure and compared among the STOP-4P, control, and observational groups.
Time frame
During the waiting period before amniocentesis and 30 minutes after amniocentesis.2
Pain Intensity After Amniocentesis Measured by the Visual Analog Scale
Participants rate the pain they experienced during amniocentesis using a Visual Analog Scale (VAS) ranging from 0 to 10. A score of 0 indicates no pain, and 10 indicates the worst pain imaginable. Higher scores indicate greater perceived pain. Scores will be compared among the STOP-4P, control, and observational groups.
Time frame
30 minutes after amniocentesis3
Changes in Heart Rate and Blood Pressure at Three Time Points
Heart rate is measured in beats per minute at three time points: during the waiting period before amniocentesis, when the participant gets onto the procedure table, and 30 minutes after amniocentesis. Systolic and diastolic blood pressure are measured at the same three time points, and mean arterial pressure (MAP) is calculated at each time point. For each participant, two changes are calculated separately for heart rate and blood pressure: the value when the participant gets onto the procedure table minus the value during the waiting period, and the value 30 minutes after amniocentesis minus the value during the waiting period. These changes will be compared among the STOP-4P, control, and observational groups.
Time frame
During the waiting period before amniocentesis; when the participant gets onto the procedure table; and 30 minutes after amniocentesis.Sponsors and contacts
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Source ClinicalTrials.gov
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