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Completed

NCT Number: NCT06555653

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

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

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Key information

Conditions

Amniocentesis Video Information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

Basaksehir Cam and Sakura City Hospital

Istanbul, Turkey (Türkiye)

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

-

Treatment and study plan

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

Primary outcomes

  1. To assess the effect of video based information on pain levels

    Time frame: 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.

  2. To assess the effect of video based information on anxiety

    Time frame: 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.

  3. To assess the effect of video based information on ease of procedure

    Time frame: 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,

  4. To assess the effect of video based information on pregnancy outcome

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Başakşehir Çam & Sakura City Hospital

Other Gov

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Aug 15, 2024
Registry last updated
Aug 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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