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

Not Applicable
Completed
Conditions
Anxiety in Pregnancy
Amniocentesis Affecting Fetus or Newborn
Pregnancy Related
Interventions
Other: Informative video
Registration Number
NCT05463549
Lead Sponsor
Wolfson Medical Center
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
Female
Target Recruitment
100
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Informative videoInformative videoThe research group will be exposed to an informative instructional film before the procedure.
Primary Outcome Measures
NameTimeMethod
Assessment of change in anxiety levels between before and after undergoing the amniocentesisEach 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 Outcome Measures
NameTimeMethod
Intensity of pain, discomfort, satisfaction with the video and satisfaction in generalThe questionnaire will be filled within 30 minutes after performing amniocentesis

These parameters will be measured using the item visual analog scales 11 questionnaire containing questions reflecting pain, discomfort and satisfaction levels. Each statement scores between 0-10 as a reflection of the patients' identification with the statement- each statement reflecting different aspects of the patients' experience:

question 1- pain during the procedure question 2- pain 10 minutes after the procedure question 3- general unpleasantness question 4- anxiety during procedure question 5- satisfaction with information about procedure question 6- overall satisfaction with treatment question 7- level of discomfort as a result of informative video prior to the amniocentesis question 8- level of anxiety caused by watching the informative video question 9-importance of informative video for understanding the amniocentesis procedure

Trial Locations

Locations (1)

Edith Wolfson Medical Center

🇮🇱

H̱olon, Israel

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