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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05463549
Other study ID # 0169-21-WOMC
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 8, 2022
Est. completion date December 30, 2022

Study information

Verified date March 2023
Source Wolfson Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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 information / eligibility

Status Completed
Enrollment 100
Est. completion date December 30, 2022
Est. primary completion date October 30, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility 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


Related Conditions & MeSH terms


Intervention

Other:
Informative video
An informative instructional film regarding the amniocentesis procedure including answers to frequently asked questions.

Locations

Country Name City State
Israel Edith Wolfson Medical Center H_olon

Sponsors (1)

Lead Sponsor Collaborator
Wolfson Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type Measure Description Time frame Safety issue
Primary Assessment of change in anxiety levels between before and after undergoing the amniocentesis 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. 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
Secondary Intensity of pain, discomfort, satisfaction with the video and satisfaction in general 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
The questionnaire will be filled within 30 minutes after performing amniocentesis
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