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

Completed

• Conditions: Video Information; Amniocentesis
• Interventions: Other: Video based multimedia information

• Registration Number: NCT06555653
• Lead Sponsor: Başakşehir Çam & Sakura City Hospital

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

Detailed Description

Amniocentesis is the most commonly used invasive prenatal diagnostic test. This study aimed to investigate the effect of video-based multimedia information (MMI) on the anxiety and pain levels of patients undergoing amniocentesis.

All consecutive women aged 18-45 years scheduled for amniocentesis were included in this prospective randomized controlled study. 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. 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, and a visual analog scale was used to evaluate pain. Pregnancy results and amniocentesis results were noted

Study Timeline

• Study Start: 2023-12-01
• Primary Completion: 2024-04-01
• Study Completion: 2024-06-20
• Status Verified: 2024-08
• Study First Submitted: 2024-08-02
• Study First Submitted QC: 2024-08-14
• Last Update Submitted: 2024-08-14
• Study First Posted: 2024-08-15
• Last Update Posted: 2024-08-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 160

Inclusion Criteria

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

Exclusion Criteria

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Subjects received video-based multmedia information	Video based multimedia information	-

Primary Outcome Measures

Name	Time	Method
To assess the effect of video based information on pain levels	01.12.2023- 01.04.2024	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.
To assess the effect of video based information on anxiety	01.12.2023- 01.04.2024	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.
To assess the effect of video based information on pregnancy outcome	01.12.2023- 01.04.2024	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.
To assess the effect of video based information on ease of procedure	01.12.2023- 01.04.2024	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,

Trial Locations

Locations (1)

Basaksehir Cam and Sakura City Hospital; 🇹🇷 İstanbul, Turkey