STOP-4P for Reducing Anxiety Before Amniocentesis

NCT07835464 | Not Yet Recruiting

• 1 other identifier: HV-STOP4P-AMNIO-2026
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Anxiety

Keywords

Amniocentesis; Psychological intervention

Outcome Measures

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.

  From the waiting period before amniocentesis to 30 minutes after amniocentesis.

Secondary Outcomes (3)

• Well-being Scores Before and After Amniocentesis

  During the waiting period before amniocentesis and 30 minutes after amniocentesis.

• Pain Intensity After Amniocentesis Measured by the Visual Analog Scale

  30 minutes after amniocentesis

• Changes in Heart Rate and Blood Pressure at Three Time Points

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

Study Arms (3)

STOP-4P With Video and Supportive Activities

EXPERIMENTAL

Participants receive routine care, watch a short informational video about amniocentesis, complete simple supportive activities, and practice the web-based STOP-4P intervention before amniocentesis.

Behavioral: STOP4P

Video and Supportive Activities Without STOP-4P

OTHER

Participants receive routine care, watch the same informational video about amniocentesis, and complete the same supportive activities as the STOP-4P group, but do not practice STOP-4P before amniocentesis.

Behavioral: Informational Video and Supportive Activities

Routine Care Only

NO INTERVENTION

Participants receive routine care only before the main post-procedure assessment and do not receive the study video, supportive activities, or STOP-4P during this period.

Interventions

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.

STOP-4P With Video and Supportive Activities

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.

Video and Supportive Activities Without STOP-4P

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hung Vuong Hospital: lead

Study Sites (1)

Hung Vuong Hospital

Ho Chi Minh City, Ho Chi Minh, 70000, Vietnam

Location

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• Callioglu N, Yildirim ZK, Tuna G. The effect of video-based multimedia information before amniocentesis on pain, anxiety, and pregnancy outcomes. Sci Rep. 2025 Mar 5;15(1):7742. doi: 10.1038/s41598-025-90929-w.

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MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Thong V Nguyen

  Hung Vuong Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Thong V Nguyen

CONTACT

+84 903194666; bsngvanthong@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Participants are unaware of their study group assignment. The physician performing amniocentesis is also unaware of group assignment and assesses procedural difficulty and clinical signs of anxiety during and immediately after the procedure.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Medical Genetics Department

Model Details: The study includes two parallel randomized groups and one additional non-randomized observational comparison group. Participants in all three groups are stratified by clinical indication for amniocentesis. Participants in the randomized component are assigned 1:1 to the STOP-4P or control group, while the observational group is enrolled separately during prespecified study sessions.

Study Record Dates

• First Submitted: September 8, 2026
• First Posted: September 23, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: September 25, 2026

Record last verified: 2026-09

Locations

VN (1)