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

NCT ID: NCT06555653

Last Updated: 2024-08-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

160 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-12-01

Study Completion Date

2024-06-20

Brief Summary

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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

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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

Conditions

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Amniocentesis Video Information

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Subjects received video-based multmedia information

Video based multimedia information

Intervention Type 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 traditional written information

No interventions assigned to this group

Interventions

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Video based multimedia information

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

\-
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Başakşehir Çam & Sakura City Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nihal Callıoglu

Role: STUDY_DIRECTOR

Başakşehir Çam & Sakura City Hospital

Locations

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Basaksehir Cam and Sakura City Hospital

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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2023-571

Identifier Type: -

Identifier Source: org_study_id

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