The Effect of Exposure to an Informative Video About Amniocentesis Before the Procedure on Maternal Anxiety

NCT ID: NCT05463549

Last Updated: 2023-03-14

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

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-08

Study Completion Date

2022-12-30

Brief Summary

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The effect of exposure to an informative video about amniocentesis before the procedure on maternal anxiety

Detailed Description

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Amniocentesis is a common sonography-guided procedure that is usually preformed during the second trimester of pregnancy in order to obtain neonatal genetic information. Previous studies have shown that although the risk of a major complication is small, many women experience profound anxiety regarding the procedure.

Many stress-relieving techniques have been proposed and studied concerning stress-related interventions during pregnancy. However, the use of an informative video that is a simple, accessible, widely accepted tool has not been tested in the context of amniocentesis. In this interventional study the investigators aim to examine the effect of an informative pre-procedural video on anxiety and pain levels in women undergoing amniocentesis.

Conditions

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Pregnancy Related Anxiety in Pregnancy Amniocentesis Affecting Fetus or Newborn

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Women assigned to undergo amniocentesis during the trail time-period will be invited to participate in the study and will be signed a consent form.The randomization will be based on different days for each intervention - a day specified to women comprising of the research group while the following clinic day will be dedicated to women from the control group.

The study group will watch an informative video while waiting for amniocentesis, and the control group will not watch the video while waiting.
Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors
Data regarding maternal characteristics, anxiety and pain levels as reported by the patients via the questioners will be stored according to random serial numbers without intervention type. The investigator handling the statistical analysis will be unaware of the patient's exposure.

Study Groups

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Informative video

The research group will be exposed to an informative instructional film before the procedure.

Group Type EXPERIMENTAL

Informative video

Intervention Type OTHER

An informative instructional film regarding the amniocentesis procedure including answers to frequently asked questions.

No video

The control group will undergo amniocentesis with information given as accepted by standard-of-care.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Informative video

An informative instructional film regarding the amniocentesis procedure including answers to frequently asked questions.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Women who come for amniocentesis in the Edith Wolfson Medical Center
* Women who sign a consent form to enroll to the study.

Exclusion Criteria

* Women under 18 years of age.
* Women who do not speak Hebrew
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Wolfson Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Or Marom, Dr

Role: PRINCIPAL_INVESTIGATOR

Edith Wolfson Medical center

Locations

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Edith Wolfson Medical Center

Holon, , Israel

Site Status

Countries

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Israel

References

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Marom O, Weiner E, Gindes L, Mor L, Gury M, Toledano E, Alon AS, Miremberg H, Shalev J, Levy M. The effect of watching an informational video prior amniocentesis on maternal anxiety: a randomized controlled trail. Arch Gynecol Obstet. 2024 Aug;310(2):1001-1008. doi: 10.1007/s00404-023-07288-y. Epub 2023 Dec 7.

Reference Type DERIVED
PMID: 38060016 (View on PubMed)

Other Identifiers

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0169-21-WOMC

Identifier Type: -

Identifier Source: org_study_id

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