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Clinical Trials/NCT05463549
NCT05463549
Completed
Not Applicable

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

Wolfson Medical Center1 site in 1 country100 target enrollmentFebruary 8, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pregnancy Related
Sponsor
Wolfson Medical Center
Enrollment
100
Locations
1
Primary Endpoint
Assessment of change in anxiety levels between before and after undergoing the amniocentesis
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

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

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
February 8, 2022
End Date
December 30, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Assessment of change in anxiety levels between before and after undergoing the amniocentesis

Time Frame: Each patient will answer the STAI questionnaire twice - within 2 hours before the operation and watching the video (S1) and within 30 minutes after performing amniocentesis (S2) to assess the change in anxiety levels before and after the operation

Women recruited to the study will answer the Spielberger's state-trait anxiety inventory questionnaire- a validated questionnaire for assessing anxiety which includes 20 statements expressing different states of anxiety. The patients will be asked to rate to what extent they currently relate to the statement written on a scale of 1 to 4 (1- does not agree at all and 4- strongly agrees). The final score in each questionnaire is obtained by summing the scores of each statement, while the scores of positive statements reflecting anxiety-free behavior will be reversely summed. Higher scores indicate higher level of anxiety.

Secondary Outcomes

  • Intensity of pain, discomfort, satisfaction with the video and satisfaction in general(The questionnaire will be filled within 30 minutes after performing amniocentesis)

Study Sites (1)

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