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

NCT07876726 | Not Yet Recruiting

• 1 other identifier: 1-26-3248
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Maternal Anxiety; Prenatal Diagnosis; Amniocentesis; Chorionic Villus Sampling

Keywords

Video-Based Patient Education; Informed Consent; STAI Score; Prenatal Genetic Testing; Decision Making

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Immediately following the counseling session (Day 1)

Secondary Outcomes (4)

• Baseline Trait Anxiety Level

  Baseline (Day 1, prior to counseling)

• Intolerance of Uncertainty Score

  Baseline (Day 1, prior to counseling)

• Impact of Primary Language Video Counseling on Anxiety Reduction

  Immediately after counseling on the same day (baseline to post-intervention)

• Influence of Obstetric History on Anxiety and Decision-Making

  Baseline (Day 1, prior to counseling)

Study Arms (4)

Group 1: Video Education - Accepted Procedure

EXPERIMENTAL

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

Group 2: Video Education - Declined Procedure

EXPERIMENTAL

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

Group 3: Standard Counseling - Accepted Procedure

ACTIVE COMPARATOR

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

Group 4: Standard Counseling - Declined Procedure

ACTIVE COMPARATOR

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

Interventions

Multilingual Video-Based Patient Education BEHAVIORAL

A standardized, multi-language educational video explaining the procedure, risks, benefits, and alternatives of invasive prenatal diagnostic tests.

Group 1: Video Education - Accepted Procedure; Group 2: Video Education - Declined Procedure

Standard Verbal Informed Consent BEHAVIORAL

Routine clinical practice involving verbal discussion and standard printed informed consent documents.

Group 3: Standard Counseling - Accepted Procedure; Group 4: Standard Counseling - Declined Procedure

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: pregnant woman
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ankara City Hospital Bilkent: lead

Study Sites (1)

Ankara Bilkent City Hospital

Ankara, Ankara, 06800, Turkey (Türkiye)

Location

Study Officials

• beste taş, md

  Ankara Bilkent City Hospital, Department of Obstetrics and Gynecology

  PRINCIPAL INVESTIGATOR

• elif gül yapar eyi, md professor

  Ankara City Hospital Bilkent

  STUDY DIRECTOR

Central Study Contacts

beste taş, md

CONTACT

5389797766; besteklc50@gmail.com

elif gül yapar eyi, md professor

CONTACT

5324096890; elifgulyapar@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A 4-Group Prospective Study

Study Record Dates

• First Submitted: October 9, 2026
• First Posted: October 15, 2026
• Study Start: October 9, 2026
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): July 30, 2027
• Last Updated: October 15, 2026

Record last verified: 2026-10

Locations

TU (1)