Effect of Video -Based vs Standard ınformation on Maternal Anxiety and Procedure Decision in Pregnant Woman Offered Amniocentesis or Cvs

NCT07876726 — Not applicable, Recruiting, 250 participants, Ankara City Hospital Bilkent

ClinicalTrials Daily  ·  Areas  ·  Conditions  ·  Drugs  ·  Sponsors  ·  

Effect of Video Based and Standard Information on Maternal Anxiety Levels and Procedure Decision in Pregnant Woman Offered Amniocentesis and Chorionic Villus Sampling: a 4 Group Prospective Study

RegistryNCT07876726
StatusRecruiting
PhaseNot applicable
Study typeInterventional; non randomized, parallel, masking: none, supportive care
Enrollment250 (Estimated)
SponsorAnkara City Hospital Bilkent (Other)
ConditionsMaternal Anxiety, Prenatal Diagnosis, Amniocentesis, Chorionic Villus Sampling
InterventionsMultilingual Video-Based Patient Education, Standard Verbal Informed Consent (Behavioral)
Datesstart 2026-10-09, primary completion 2027-04-30 (estimated), completion 2027-07-30 (estimated), first posted 2026-10-15, last updated 2026-10-21
Locations1 site in Turkey (Türkiye)

Related Papers Related Patents Related Grants Related Experts
All trials for Maternal Anxiety All trials for Prenatal Diagnosis All trials of Multilingual Video-Based Patient Education All trials of Standard Verbal Informed Consent

-Summary

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.

Expand all sections  ·  Collapse all

+Detailed description

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.

+Arms and interventions

ArmTypeInterventionsDescription
Group 1: Video Education - Accepted ProcedureExperimentalBehavioral: Multilingual Video-Based Patient EducationPregnant women who received video-based educational material prior to informed consent and decided to undergo the offered invasive prenatal diagnostic procedure (amniocentesis or CVS).
Group 2: Video Education - Declined ProcedureExperimentalBehavioral: Multilingual Video-Based Patient EducationPregnant women who received video-based educational material prior to informed consent and decided to decline the offered invasive prenatal diagnostic procedure (amniocentesis or CVS).
Group 3: Standard Counseling - Accepted ProcedureActive comparatorBehavioral: Standard Verbal Informed ConsentPregnant women who received standard verbal informed consent and decided to undergo the offered invasive prenatal diagnostic procedure (amniocentesis or CVS).
Group 4: Standard Counseling - Declined ProcedureActive comparatorBehavioral: Standard Verbal Informed ConsentPregnant women who received standard verbal informed consent and decided to decline the offered invasive prenatal diagnostic procedure (amniocentesis or CVS).
  • Multilingual Video-Based Patient Education (Behavioral): A standardized, multi-language educational video explaining the procedure, risks, benefits, and alternatives of invasive prenatal diagnostic tests.
  • Standard Verbal Informed Consent (Behavioral): Routine clinical practice involving verbal discussion and standard printed informed consent documents.

+Outcome measures

Primary outcomes

  • Change in Maternal State Anxiety Level [Immediately before and after counseling on the same day (baseline and post-intervention)]: 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.
  • Procedure Acceptance Rate [Immediately following the counseling session (Day 1)]: Percentage of pregnant women who decide to undergo or decline the offered invasive prenatal diagnostic procedure (amniocentesis or CVS) following the counseling session.

Secondary outcomes

  • Baseline Trait Anxiety Level [Baseline (Day 1, prior to counseling)]: 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.
  • Intolerance of Uncertainty Score [Baseline (Day 1, prior to counseling)]: 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.
  • Impact of Primary Language Video Counseling on Anxiety Reduction [Immediately after counseling on the same day (baseline to post-intervention)]: 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.
  • Influence of Obstetric History on Anxiety and Decision-Making [Baseline (Day 1, prior to counseling)]: 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.

+Eligibility

Sex: Female, ages: 18 Years to 45 Years, accepts healthy volunteers

Inclusion Criteria

* Presenting to the Perinatology Unit,
* Aged between 18 and 45 years,
* Having a singleton and live pregnancy,
* Recommended for invasive prenatal diagnostic testing due to medical indications,
* Proficient in reading, writing, and understanding the Turkish language,
* Willing to participate in the study (consenting to informed consent).

Exclusion Criteria:

* Having a history of psychiatric disorders or depression,
* Currently using psychiatric/psychotropic medication,
* Having a history of invasive procedures in previous pregnancies,
* Having a multiple pregnancy,
* Having visual, auditory, or cognitive impairments,
* Leaving more than 3 questions unanswered in the data collection tools (scales and forms) or withdrawing/dropping out of the study before completion.

+Locations (1)

FacilityCityCountryStatus
Ankara Bilkent City HospitalAnkara, AnkaraTurkey (Türkiye)Recruiting

+Investigators

  • beste taş, md, Principal investigator, Ankara Bilkent City Hospital, Department of Obstetrics and Gynecology
  • elif gül yapar eyi, md professor, Study director, Ankara City Hospital Bilkent