An interventional study of Multilingual Video-Based Patient Education and Standard Verbal Informed Consent in Maternal Anxiety, Prenatal Diagnosis and Amniocentesis, sponsored by Ankara City Hospital Bilkent. Recruiting at 1 site in Turkey (Türkiye). Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-21.
Sponsored by Ankara City Hospital Bilkent · Not applicable, Interventional, and Supportive care
This prospective study evaluates the impact of video-based patient education compared to standard verbal informed consent on state anxiety levels and procedure acceptance rates in pregnant women undergoing invasive prenatal diagnostic testing (amniocentesis or chorionic villus sampling). Participants are assigned to four groups based on their video preference and procedural recommendation to assess changes in anxiety scores (STAI-S) before and after counseling, as well as final decisions regarding the procedure.
Invasive prenatal diagnostic procedures, such as Amniocentesis and Chorionic Villus Sampling (CVS), are associated with significant maternal anxiety driven by fear of procedural complications, pregnancy loss, and uncertainty regarding fetal health. Standard verbal informed consent processes may sometimes fail to fully address patient concerns due to time constraints or complex medical terminology.
This prospective study aims to investigate whether standardized, multilingual video-based educational material enhances patient comprehension, reduces state anxiety, and influences procedure acceptance rates among women offered invasive prenatal testing.
The study includes four distinct arms/groups based on the intervention type (video-assisted vs. standard consent) and the recommended procedure (amniocentesis vs. CVS). Baseline maternal characteristics, state-trait anxiety levels (STAI-T and STAI-S), and Intolerance of Uncertainty Scale (IUS-27) scores are evaluated at baseline (T0). Post-counseling anxiety levels (STAI-S) and the final decision to undergo or decline the recommended procedure (T1) are subsequently recorded and analyzed across groups.
Ankara City Hospital Bilkent is the lead sponsor of 437 studies on the registry; 109 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Pregnant women who received video-based educational material prior to informed consent and decided to undergo the offered invasive prenatal diagnostic procedure (amniocentesis or CVS).
Behavioral: Multilingual Video-Based Patient Education
Pregnant women who received video-based educational material prior to informed consent and decided to decline the offered invasive prenatal diagnostic procedure (amniocentesis or CVS).
Behavioral: Multilingual Video-Based Patient Education
Pregnant women who received standard verbal informed consent and decided to undergo the offered invasive prenatal diagnostic procedure (amniocentesis or CVS).
Behavioral: Standard Verbal Informed Consent
Pregnant women who received standard verbal informed consent and decided to decline the offered invasive prenatal diagnostic procedure (amniocentesis or CVS).
Behavioral: Standard Verbal Informed Consent
A standardized, multi-language educational video explaining the procedure, risks, benefits, and alternatives of invasive prenatal diagnostic tests.
Routine clinical practice involving verbal discussion and standard printed informed consent documents.
Change in Maternal State Anxiety Level
Assessed using the State-Trait Anxiety Inventory-State (STAI-S) subscale (scores range from 20 to 80, with higher scores indicating higher state anxiety). Measured before and immediately after the educational intervention or standard counseling.
Time frame: Immediately before and after counseling on the same day (baseline and post-intervention)
Procedure Acceptance Rate
Percentage of pregnant women who decide to undergo or decline the offered invasive prenatal diagnostic procedure (amniocentesis or CVS) following the counseling session.
Time frame: Immediately following the counseling session (Day 1)
Baseline Trait Anxiety Level
Evaluated using the State-Trait Anxiety Inventory-Trait (STAI-T) subscale (scores range from 20 to 80, higher scores indicate greater dispositional anxiety) to assess its baseline influence on maternal decision-making and response to video education.
Time frame: Baseline (Day 1, prior to counseling)
Intolerance of Uncertainty Score
Assessed using the Intolerance of Uncertainty Scale (IUS-27) to evaluate baseline individual tolerance to uncertain outcomes and its potential mediating effect on procedure decision and post-counseling state anxiety.
Time frame: Baseline (Day 1, prior to counseling)
Impact of Primary Language Video Counseling on Anxiety Reduction
Comparison of post-counseling state anxiety score (STAI-S) changes across patient subgroups receiving video-based education in their primary language (including Turkish, English, and Arabic) versus standard consent procedures.
Time frame: Immediately after counseling on the same day (baseline to post-intervention)
Influence of Obstetric History on Anxiety and Decision-Making
Evaluation of the association between baseline state anxiety (STAI-S) and procedure acceptance rates with maternal demographic and obstetric factors, including gestational age, gravidity, parity, prior history of invasive diagnostic procedures, and specific indication for prenatal testing.
Time frame: Baseline (Day 1, prior to counseling)
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Ankara City Hospital Bilkent →