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NCT Number: NCT07835464

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.

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Key information

Conditions

Anxiety Anxiety Disorders Mental Disorders

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

STOP4P

Behavioral

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

Behavioral

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.

Primary outcomes

  1. Changes in State and Trait Anxiety Scores Before and After Amniocentesis

    Time frame: From the waiting period before amniocentesis to 30 minutes 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.

Secondary outcomes

  1. Well-being Scores Before and After Amniocentesis

    Time frame: During the waiting period before amniocentesis and 30 minutes 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.

  2. Pain Intensity After Amniocentesis Measured by the Visual Analog Scale

    Time frame: 30 minutes after amniocentesis

    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.

  3. Changes in Heart Rate and Blood Pressure at Three Time Points

    Time frame: During the waiting period before amniocentesis; when the participant gets onto the procedure table; and 30 minutes after amniocentesis.

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Thong V Nguyen

CONTACT

[email protected]

+84 903194666

Sponsors and collaborators

Lead sponsor

Hung Vuong Hospital

Other

Registry information

Official study title

Effectiveness of STOP-4P in Reducing Anxiety Among Pregnant Women Undergoing Amniocentesis: A Randomized Controlled Trial at Hung Vuong Hospital

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Sep 23, 2026
Registry last updated
Sep 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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