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

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

Study Overview

• Status: Completed
• Conditions: Pregnancy Related; Anxiety in Pregnancy; Amniocentesis Affecting Fetus or Newborn
• Intervention / Treatment: Other: Informative video

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.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • H̱olon, Israel, 5822012
    • Edith Wolfson Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Informative video; The research group will be exposed to an informative instructional film before the procedure.	Other: Informative video; An informative instructional film regarding the amniocentesis procedure including answers to frequently asked questions.
No Intervention: No video; The control group will undergo amniocentesis with information given as accepted by standard-of-care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Wolfson Medical Center
• Investigators: Principal Investigator: Or Marom, Dr, Edith Wolfson Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): February 8, 2022
• Primary Completion (Actual): October 30, 2022
• Study Completion (Actual): December 30, 2022

Study Registration Dates

• First Submitted: March 27, 2022
• First Submitted That Met QC Criteria: July 17, 2022
• First Posted (Actual): July 19, 2022

Study Record Updates

• Last Update Posted (Actual): March 14, 2023
• Last Update Submitted That Met QC Criteria: March 13, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: pregnancy; explanatory video; anxiety reduction; amniocentesis
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: 0169-21-WOMC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Unidentified patient data will be shared between researchers for statistical analysis, other unidentified data will be published.
• IPD Sharing Time Frame: Within the first 5 years from publication.
• IPD Sharing Access Criteria: Researches in need of data will request permission from study organizers by mail including data needed, purpose of data sharing and data protection steps.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No