The Effect of Video-based Multimedia Information Before Amniocentesis on Pain, Anxiety and Pregnancy Outcomes

NCT06555653 | Completed

• 1 other identifier: 2023-571
• Study Type: observational
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to assess the effect of video-based multimedia information before amniocentesis on pain, anxiety and pregnancy outcomes

Conditions

Amniocentesis; Video Information

Keywords

Video-based information, amniocentesis

Outcome Measures

Primary Outcomes (4)

• To assess the effect of video based information on pain levels

  Subjects were assigned to receive video-based MMI or traditional written information (controls). A standard amniocentesis procedure was performed on all patients by the same perinatology physicians. After amniocentesis a visual analog scale was used to evaluate pain.

  01.12.2023- 01.04.2024

• To assess the effect of video based information on anxiety

  Subjects were assigned to receive video-based MMI or traditional written information (controls). Anxiety levels were assessed at the first admission using the State and Trait Anxiety Inventory-State (STAI-S). After MMI and written information, STAI-S was repeated before the procedure.

  01.12.2023- 01.04.2024

• To assess the effect of video based information on ease of procedure

  Subjects were assigned to receive video-based MMI or traditional written information (controls). A standard amniocentesis procedure was performed on all patients by the same perinatology physicians. After amniocentesis, a Likert scale was used to evaluate the ease of the procedure and patient satisfaction,

  01.12.2023- 01.04.2024

• To assess the effect of video based information on pregnancy outcome

  Subjects were assigned to receive video-based MMI or traditional written information (controls).The birth outcomes were compared between the two groups in terms of live birth, termination of pregnancy, and intrauterine death.

  01.12.2023- 01.04.2024

Study Arms (2)

Subjects received video-based multmedia information

Other: Video based multimedia information

Subjects received traditional written information

Interventions

Video based multimedia information OTHER

The intervention group was shown a 5 minute informational video before amniocentesis including definition of amniocentesis, its indications, the setup of amniocentesis room, the purpose and steps of the procedure, potential complications and how to manage them

Subjects received video-based multmedia information

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: All consecutive women aged 18-45 years scheduled for amniocentesis
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Women who received video based multimedia information about amniocentesis

You may qualify if:

• All consecutive women aged 18-45 years scheduled for amniocentesis

Sponsors & Collaborators

• Başakşehir Çam & Sakura City Hospital: lead

Study Sites (1)

Basaksehir Cam and Sakura City Hospital

Istanbul, Turkey (Türkiye)

Location

Study Officials

• Nihal Callıoglu

  Başakşehir Çam & Sakura City Hospital

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2024
• First Posted: August 15, 2024
• Study Start: December 1, 2023
• Primary Completion: April 1, 2024
• Study Completion: June 20, 2024
• Last Updated: August 15, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)