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

Pregnancy Related Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05463549
• Other study ID #: 0169-21-WOMC
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Amniocentesis Affecting Fetus or Newborn
• Anxiety Disorders
• Pregnancy Related

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